Post on 07-Aug-2020
transcript
HY
PH
EN
Bio
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In V
itro
Dia
gnos
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(IV
D) R
eage
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Res
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ioch
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Kit
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HYP
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Bio
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Dear Valued Customers,
In the 14 years since its foundation in 1999 Hyphen Biomed has established itself as a key player in all areas of the Thrombosis and Heamostasis marketplace including routine and research biomedical laboratories, the biotech and pharmaceutical industries whether they are involved in drug discovery, marketing of extracted or recombinant blood derived products or anticoagulant anti-thrombotic treatments.
We continue in our commitment to offer highly innovative products, backed up by high quality and service that we bring to the scientific and medical fields. Hyphen is dedicated to use the best expertise and experience we have acquired to achieve these goals.
This catalogue contains not only unique products but also a comprehensive line of standardised and optimised diagnostic kits for diagnosis of Thrombosis and Hemostasis. These areas are complemented by custom manufacture to the specific needs of industry.
Please note in this catalogue special focus is given to the testing of the new anticoagulants with kits, calibrators and controls developed by us.
Discover all our innovations on our website at www.hyphen-biomed.com or contact us at +33 1 34 40 65 10.
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*Kits and biochemicals presentation in this catalogue are subjected to minor changes when required; this catalogue content presents our offer but is not contractual.
IntroductionTable of ContentsExplanation of symbols used
134
36373839
PART 5 : LUPUS ANTICOAGULANTS ANDANTI-PHOSPHOLIPID ANTIBODIES (ACA/APA) 35
43PART 6 : CALIBRATORS AND CONTROLS
PART 8 : EXPLORATION OF FIBRINOLYSIS 61
Assays for fibrinolysis proteinsCardiovascular (liquid technology)
6265
PART 7 : AUXILIARY REAGENTS 55
Plasma factors and cofactorsHeparin and analoguesFactor V-LDirect Thrombin InhibitorsDirect FXa inhibitorsNon titrated human plasmas (normal)Enzyme immuno-assaysELITEST line of cardiovascular assays
4445484950515154
Reference materialELISA SubstratesBuffers for chromogenic assaysBuffers and solutions for clotting assaysBuffers and solutions for ElisaSolutions for microparticles
565656575960
PART 1 : ROUTINE ASSAYS 5
PART 2 :MEASUREMENT OF PLASMA FACTORSand their activated forms 9
PART 3 : THROMBOPHILIA 20
Antithrombin III activity and antigen Protein C activity and antigen Protein S activity and Protein S Free and Total antigens Protein Z antigen Factor V-L (involved in APC resistance) Heparin CoFactor II activity D-Dimer Thrombin generation (release of FPA) Lupus anticoagulants Microparticles
2122
2324252526262626
PART 4 : ANTICOAGULANT DRUGS 28
Heparin and heparin like substancesHeparin Induced Thrombocytopenia (HIT)Monostrip HIT
293133
Prothrombin Time (PT) reagents Activated Partial Thrombin Time (aPTT) reagents Thrombin Time Fibrinogen
66, 7
78
Prothrombin activity Factor V activity and antigen Factor VII activity and antigen Factor VIIa activity Factor VII+X activity Factor VIII:C activity Auto-antibodies to Factor VIII:C Factor IX activity and antigen Factor IXa activity Factor X activity and antigen Factor XIa activity Factor XIII antigen Von Willebrand Factor antigen and activity Deficient plasmas, immuno depleted
1010111212121313141414151516
29Heparin
34New Oral anticoagulants (NOACs: dtiS, DiXAIs)
3434
Direct thrombin inhibitorsDirect FXa inhibitors
Table of Contents*Diagnostic and research reagents for Thrombosis, Hemostasis and Autoimmunity
Lupus anticoagulantsAnti-Cardiolipin/Anti-phopholipid antibodies (ACA/APA)Anti-β2GP1 auto-antibodies Auto-antibodies to Phospholipid cofactor proteins
Pricing and orderingTerms and conditions of saleIndex
959697
PART 9 : AGGREGOMETRY 66
Recombinant human proteins
IMMUNOCHEMICALS
ANIMAL MODELS
83
89
92
Human enzymes 84
Human enzymes 78
Bovine proteins
Polyclonal antibodies
Bovine enzymes
Monoclonal antibodies
Other proteins and enzymes
Miscellaneous
86
89
87
91
88
88
Cross-reactivities with homologous animalproteins for the various ZYMUTEST kits 93
Hemostasis and Fibrinolysis human proteinsMiscellaneous Vitamin K dependent proteinsPlatelet proteins
78818182
Rat �brinolysisRat biochemicalsRat immunochemicals
929293
ADPEpinephrineArachidonic AcidRistocetinCollagenLyophilized platelets
676767686868
94GENERAL INFORMATION
Substrates for ThrombinSubstrates for Factor XaSubstrate for Activated Protein CSubstrate for KallikreinSubstrate for Plasmin and Plasminogen – SKSubstrate for Factor IXaSubstrate for UrokinaseBroad spectrum substrate for tPA
7474757575767676
Chromogenic substrates 74
Other Hemostasis proteins 72
Thrombosis and vascular diseases 70
Table of proteins involved in Hemostasis and Fibrinolysis 77
Fluorogenic substrate for Factor Xa 76
Fluorogenic substrates 76
74BIOCHEMICALS
READY TO USE ASSAYS
BIOLOGICALS
EXPLANATION OF SYMBOLS
*Kits and biochemicals presentation in this catalogue are subjected to minor changes when required; this catalogue content presents our o�er but is not contractual.
The symbols below indicate the intended use and regulatory status of the products in various countries.
These kits are intended for In Vitro Diagnostic Use in countries where they are appropriately marked, cleared, approved, or licensed.
These kits are intended for Research Use Only in all countries and are not intended to be used for diagnostic procedures.
These kits are manufactured in compliance with the 98/79 CE Directive for In-Vitro Diagnostic devices. Only CE marked products can be used for diagnostic applications in Europe.
These kits are cleared by the US FDA for in vitro diagnostic use in the United States.
HYPHEN BioMed,An ISO 9001 and ISO 13485Certi�ed company
IVD
RUO
CE
510(k)
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PART 10 : RESEARCH KITS 69
High sensitivity C-Reactive Protein (CRP)Tissue FactorPlatelet markers
707071
Plasma factors(Annexin V, B2GPI, Fibrinogen, Fibronectin)
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PART 1 :
ROUTINE ASSAYS
Complete line of routine assays for hemostasis testing
PART
1 :
ROUT
INE A
SSAY
S
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PART 1: ROUTINE ASSAYS
Prothrombin Time (PT)
THROMBOPHENCalcium Thromboplastin CE
#CK550K / CK550M / #CK550L #CK551K / CK551M / #CK551L
Thromboplastin reagents (containing recombinant rabbit tissue factor) for the determination of Prothrombin Time (PT) on citrated human plasma, using a manual, semi-automated or automated clotting method. Two different ISI are proposed: Low ISI (THROMBOPHEN HS) or High ISI (THROMBOPHEN LS).
Pres
enta
tion
Ready to use reagents
THROMBOPHEN HS (Low ISI)6x2.5 mL (CK550K)6x5 mL (CK550M)6x10 mL (CK550L)
THROMBOPHEN LS (High ISI)6x2.5 mL (CK551K)12x5 mL (CK551M)6x10 mL (CK551L) A
ssay
cha
ract
eris
tics
Total Assay Time: < 5 min.Intra-Assay CV: < 3 %Inter-Assay CV: < 5%
Number of tests: 150 tests (CK550K) 300 tests (CK550M)
600 tests (CK550L)150 tests (CK551K)
600 tests (CK551M)600 tests (CK551L)
Established against the International Standard thromboplastin (rabbit).
Intended use : This test is used to explore a congenital or acquired bleeding tendency (in one of the factors associated with the coagulation extrinsic pathway: Factor II, V, VII, X), liver diseases, vitamin K deficiencies, fibrinolysis, DIC. PT test is the most commonly used coagulation assay for laboratory monitoring of anticoagulant therapy with vitamin K antagonists (VKA) such as dicumarol.
PT does not explore factor deficiencies of the intrinsic coagulation pathway (Factors VIII, IX, XI, and XII), platelets, Factor XIII or natural inhibitors of coagulation (antithrombin, Protein C and Protein S).
CEPHENLupus Anticoagulant ResistantAPTT (intrinsic pathway)
CE #CK511K / #CK512K#CK515K / #CK515L
Reagent, for the determination of Activated Partial Thromboplastin Time (APTT) on citrated human plasma, using a manual, semi-automated or automated clotting method. Low sensitivity to Lupus Anticoagulant.
Pres
enta
tion
Ready to use reagents
CEPHEN 16x1 mL (CK511K)
CEPHEN 2.56x2.5 mL (CK512K)
CEPHEN 58x5 mL (CK515K)12x5 mL (CK515L)
Ass
ay c
hara
cter
isti
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Total Assay Time: < 5 min.Intra-Assay CV: < 0.6 %Inter-Assay CV: < 2.5 %Number of tests: 6x10 tests (CK511K) 6x25 tests (CK512K) 8x50 tests (CK515K) 12x50 tests (CK515L)
Intended use : Measurement of the plasma recalcification time, in presence of the standardized APTT (Activated Partial Thromboplastin Time) reagent (cephalin and activator), on human citrated plasma, to explore the activity of the intrinsic pathway coagulation factors (II, V, VIII:C, IX, X, XI, XII) and “anticoagulant” activities.
Activated Partial Clotting Time (APTT)
IVD
IVD
HEMOCLOT Thrombin Time (T.T.)Thrombin Time (Conventional/Bovine Thrombin) CE #CK011K / #CK011L
Reagent for the determination of Thrombin Time (TT) on human citrated plasma, using a clotting method, which can be manual, semi-automatic or automatic. Measurement of the clotting time induced by bovine thrombin, in presence of calcium, on plasma, and exploration of the anti-thrombin activities. Excellent sensitivity to low concentrations of heparin in plasma (from 0.05 to 0.10 IU/mL Unfractionated Heparin (UFH), or from > 0.20 IU/mL Low Molecular Weight Heparin (LMWH) in plasma).
Pres
enta
tion
Highly purified bovine thrombin (a form)
6x2 mL (CK011K)
6x8 mL (CK011L)
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 2 min.Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: 6x20 tests (CK011K) 6x80 tests (CK011L)
Intended use : Conventional Thrombin Time, highly sensitive to heparins and thrombin inhibitors.
Thrombin Time (TT)
IVD
HEMOCLOT Thrombin (Human)Thrombin Time with Human ThrombinLow DTI concentrations
CE in progress #CK001K / #CK001L
Optimized Thrombin Time in presence of calcium, designed with highly purified human thrombin, mainly in the a-form, which is very stable (> 7 days at room temperature or > 3 weeks at 2-8°C). This thrombin is obtained by activation of purified human Prothrombin, in presence of factor Xa, Phospholipids, factor V and calcium, followed by the specific purification of thrombin and its stabilization. It is a «True Thrombin Time» using highly purified, fully active, human Thrombin.
Pres
enta
tion
Highly purifiedhuman thrombin (a-form)
6x2 mL (CK001K)
6x8 mL (CK001L)
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 2 min.Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: 6x20 tests (CK001K) 6x80 tests (CK001L)
Intended use : Assay proposed for the measurement of Thrombin Time in research applications.
RUO
CEPHEN LSLupus Anticoagulant SensitiveAPTT (intrinsic pathway)
CE #CK521K / #CK522K
Reagent, for the determination of Activated Partial Thromboplastin Time (APTT) on citrated human plasma, using a manual, semi-automated or automated clotting method. This reagent offers a good sensitivity to the presence of Lupus Anticoagulant.
Pres
enta
tion
Liquid reagent. Ready to use
CEPHEN 1 LS6x1 mL (CK521K)
CEPHEN 2.5 LS6x2.5 mL (CK522K)
Ass
ay c
hara
cter
isti
cs Total Assay Time: < 5 min.Intra-Assay CV: < 0.6%Inter-Assay CV: < 2.5%Number of tests: 6x10 tests (CK521K)
6x25 tests (CK522K)
Intended use : Measurement of the plasma recalcification time, in presence of the standardized APTT (Activated Partial Throm-boplastin Time) reagent (cephalin and activator), on human citrated plasma, to explore the activity of the intrinsic pathway coagulation factors (II, V, VIII:C, IX, X, XI, XII) and “anticoagulant” activities.
IVD
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CALIBRATORS AND CONTROLSRefer to page 43
FIBRIPHENFibrinogen Measurement in Plasma withthe Von Clauss Method
CE#CK571K
#CK572K / #CK575K
Thrombin reagent proposed for the quantitative determination of Fibrinogen in human citrated plasma using a clotting method (Clauss method).
Pres
enta
tion
Reagent containing calciumthrombin from bovine origin:about 100 NIH/ml.
FIBRIPHEN 16x1 mL (CK571K)
FIBRIPHEN 26x2 mL (CK572K)
FIBRIPHEN 58x5 mL (CK575K)
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 3 min.Intra-Assay CV: < 3%Inter-Assay CV: < 4%Dynamic range: 1–12 g/LNumber of tests: 6x10 tests (CK571K)
6x20 tests (CK572K)8x50 tests (CK575K)
Intended use : Measurement of fibrinogen in plasma.Detection of low fibrinogen concentrations.Detection of elevated fibrinogen concentrations (> 4g/L) : In clinical situations associated with inflammation ; Risk factor for cardiovascular disease and thrombosis ; Hypofibrinogenemia, mainly associated with severe liver disease, and excessive consumption of fibrinogen (DIC, hyperfibrinolysis).Numerous variants of fibrinogen described, associated to asymptomatic cases, or to cases with bleeding and/or thrombosis.
Fibrinogen (Von Claus method)
IVD
LIAPHEN Fibrinogen Fibrinogen Latex Immunoassay CE #120102
Latex immunoassay for measuring Fibrinogen in human citrated plasma or in purified milieu (cell culture supernatant), using a manual or automated method, in vitro exclusively.
Pres
enta
tion
4x5 mL Latex reagent4x25 tests
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 20 min.Detection Threshold: 1 µg/mLDynamic Range: 0-10 µg/mLIntra-Assay CV: < 4%Inter-Assay CV: < 8%No hook effect is observed for Fibrinogen concentra-tions < 100µg/mL
No interference is observed for Unfractionated Heparin concentrations < 2 IU/ml in plasma.
The presence of rheumatoid factor may result in an overestimation of the Fibrinogen concentration.
Intended use : Assay of Fibrinogen in human citrated plasma or in cell culture supernatants.
IVD
ZYMUTEST Fibrinogen Fibrinogen Immunoassay #RK024A
Two-site ELISA method for the measurement of Fibrinogen. Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.
Useful for testing low fibrinogen concentrations in culture media or cell exsudates, and for various research applications.
Pres
enta
tion
12x8 test kit2x B2F Sample Diluent3x Fibrinogen Standard1x high & low Fibrinogen controls3x Anti-h-Fibrinogen-HRP IC1x B2F Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h15Detection Threshold: 1 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 – 6%Inter-Assay CV: 5 – 8%
Specimen dilution must be adjusted to the expected concentration.Reactive with rat and mouse Fibrinogen.
Intended use : Assay proposed for the measurement of Fibrinogen in research applications.
RUO
9
PART 2 :
MEASUREMENT OF PLASMA FACTORS
and their activated forms
Measurement of plasma factors and some of their activated formsinvolved in coagulation and thrombosis using clotting,
chromogenic or immunological methods.
PART
2 :
PLAS
MA
FACT
ORS
10
PART 2 : PLASMA FACTORS
Biophen® ProthrombinProthrombin Chromogenic Assay #221605
Chromogenic assay for the quantitative determination of Prothrombin in human citrated plasma or in concentrates, using a manual or automated protocol.
Very useful assay for elevated Prothrombin concentrations.
Pres
enta
tion
R1: 4x2.5 mL Ecarin®, which specifically activates Prothrombin into meizothrombin
R2: 4x5 mg Chromogenicsubstrate, specific forThrombin (SIIa-01)
R3: 4x5 mL x10 concen-tratedTris-BSA buffer
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 5 min.Detection Threshold: ≤ 5%Dynamic Range: 5-200%Intra-Assay CV: 2 - 5%Inter-Assay CV: 3 - 6%
Not sensitive to the presence of heparin in plasma up to a concentration of at least 2 IU/mL.
Intended use : Assay proposed for the measurement of Prothrombin in research applications.
Prothrombin Activity
RUO
HEMOCLOT Factor V ReagentFactor V Clotting Test CE #CK071K
Assay designed with a Factor V deficient clotting mixture, containing highly purified Fibrinogen and a Prothrombin complex concentrate.
Must be used in combination with a commercially available Calcium Thromboplastin. Pr
esen
tati
on
FV deficient clotting mixture (Fibrinogen and Prothrombin complex concentrate)
6x1 mL
Ass
ay c
hara
cter
isti
cs Total Assay Time: < 3 min.Detection Threshold: < 1%Dynamic Range: 0 to 100%Intra-Assay CV: < 4%Inter-Assay CV: < 7%Number of tests: 6x10 tests
Intended use : FV deficiency, congenital or acquired.Hepatic disorders.DIC.
Factor V Activity and Antigen
IVD
ZYMUTEST Factor VFactor V immunoassay
#RK009A
Two-site ELISA method for the measurement of human factor V antigen. Assay designed with a monoclonal antibody specific for the factor V heavy chain, for coating the microplate (immunocapture), and a horse anti-factor V polyclonal antibody, coupled to peroxidase, for revelation. This assay preferentially measures native factor V, and is also reactive with factor Va, but with a decreased reactivity.
Pres
enta
tion
12x8 test kit2x FV Sample Diluent3x Plasma FV Calibrator1x high & low FV controls3x Anti-h-FV-HRP IC1x FV Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 4h05Detection Threshold: 2 ng/mLDynamic Range: 0 to 200 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%
Intended use : Assay proposed for the measurement of Factor V antigen in research applications.
RUO
11
HEMOCLOT Factor VII ReagentFactor VII Clotting Test CE #CK081K
Assay designed with a Factor VII deficient clotting mixture, containing highly purified bovine Fibrinogen and Factor V, human Prothrombin and Factor X complex concentrate.
Must be used in combination with a commercially available Calcium Thromboplastin.
Pres
enta
tion
FVII deficient clotting mixture (bovine Fibri-nogen and FV, human Prothrombin and FX complex concentrate)
6x1 mL
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 3 min.Detection Threshold: < 1%Dynamic Range: 0 to 100%Intra-Assay CV: < 4%Inter-Assay CV: < 7%Number of tests: 6x10 tests
Intended use : FVII deficiency, congenital or acquired. Vitamin K deficiency (hepatic diseases, primary biliary cirrhosis, deficiency in newborns, antibiotherapy) Vitamin K antagonists (dicoumarol therapy) Isolated deficiencies of factor VII. Accelerated clotting factor consumption (DIC)
Factor VII Activity and Antigen
IVD
ZYMUTEST Factor VIIFactor VII Immunoassay #RK036A
Two-site immuno-assay for measuring human Factor VII (FVII) Antigen in plasma, or in any fluid where FVII can be present.
Assay designed with a rabbit polyclonal antibody specific for FVII for coating the ELISA plate and preparation of horse radish peroxidase (HRP). Pr
esen
tati
on
12x8 test kit2x Sample Diluent3x Plasma FVII Calibrator1x high & low Plasma controls3x Anti-h-FVII-HRP IC 1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 1h30 (one step method)Detection Threshold: ≤ 5%Dynamic Range: 0 to 25 ng/mLIntra-Assay CV: 3-5%Inter-Assay CV: 3-8%
No Significant interference of Heparin up to 2 IU/mL
Reference Material: NIBSC International Standard
Intended use : Assay proposed for the measurement of Factor VII antigen in research applications.
RUO
Biophen® FVIIFactor VII Chromogenic Assay #221304
Chromogenic assay for the measurement of Factor VII activity in human plasma, Factor VII in concentrates or in biological fluids. Automatic or Manual method.
Pres
enta
tion
R1: 2 vials containing H FX
R2: 2 vials of rabbit brainThromboplastin, containingcalcium
R3: 2x8 mg Chromogenic substrate, specific for FXa (SXa-11)
R4 : 4x25 mL of Tris-BSA Buffer, at pH 7.40
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 12 min.Detection Threshold: 5%Dynamic Range: 5 to 200%Intra-Assay CV: 3 - 5%Inter-Assay CV: 4 – 7% Reference Material NIBSC International Standard
Intended use : Assay proposed for the measurement of Factor VII activity in research applications.
RUO
12
Biophen® Factor VIIa (Activated FVII) Factor VIIa Chromogenic Assay #221312
Chromogenic assay for the quantitative determination of Factor VIIa (Activated FVII, FVIIa) activity, in purified milieu (or biological fluids), using manual or automated method.
Pres
enta
tion
R1: 2 vials containing H FX
R2: 2 vials of FVIIa cofactor(rTTF) and syntheticphospholipids
R3: 2x Chromogenic substrate, specific for FXa (SXa-11)
R4 : 4x25 mL of Tris-BSA Buffer, at pH 7.50 A
ssay
cha
ract
eris
tics
Total Assay Time: 12 min.Detection Threshold: 1 ng/mLDynamic Range: 0 to 50 ng/mLIntra-Assay CV: < 6%Inter-Assay CV: < 10%
Intended use : Assay proposed for the measurement of Factor VIIa activity in research applications.
HEMOCLOT VII-XClotting Test for Combined Factor VII and X Activities CE #CK051K / #CK051L
Assay designed for the specific measurement of combined Factors VII+X in human citrated plasma. The assay measures Factors VII+X in human citrated plasma using a clotting method, triggered with calcium thromboplastin. It is proposed as screening for Factor VII or Factor X deficiency with a single test. Highly stable and fully reproducible assay from lot to lot.The ideal screening assay for the combined diagnosis of Factor VII and X clotting activity deficiencies.
Pres
enta
tion
Deficient FVII and FXclotting mixture (highlypurified bovine Prothrom-bin, Fibrinogen and FV)
6x1 mL (CK051K)20x1 mL (CK051L)
Ass
ay c
hara
cter
isti
csTotal Assay Time: < 4 min.Detection Threshold: < 5%Dynamic Range: 0 to 100%Intra-Assay CV: < 5%Inter-Assay CV: < 8%Number of tests: 6x10 tests (CK051K)
20x10 tests (CK051L)
Intended use : Vitamin K deficiency. Vitamin K antagonists.Isolated factor VII or X deficiency.Accelerated clotting factor consumption (DIC).
Factor VIIa Activity
Factors VII+X Activity
RUO
IVD
Biophen® FVIII:CFactor VIII:C Chromogenic Assay CE #221402 / #221406
Chromogenic assay for the measurement of Factor VIII:C activity in human plasma, factor VIII:C concentrates, or Factor VIII:C in biological fluids. Automatic or Manual method. Calibrator plasma and controls (at two levels) are available (see p XX). This assay offers two working ranges for factor VIII:C (Low: 0 to 25% and High: 0 to 200%).
It is indicated for measuring low (hemophilia A) or high (increased thrombotic risk) factor VIII:C concentrations in human citrated plasma, and in factor VIII:C concentrates.
Pres
enta
tion
R1: Human FX
R2: Activation Reagent
R3: FXa (SXa-11) Chro-mogenic substrate
R4: Tris-BSA Buffer
#221402 (2.5 mL) 2x2.5 mL: R1,R2,R34x25 mL: R4
#221406 (6 mL)2x6 mL: R1,R2,R34x25 mL: R4
Ass
ay c
hara
cter
isti
cs
Total Assay Time: ≤ 10 min.Detection Threshold: 10% (high range) 0.2% (low range)Dynamic Range: 5 to 200% (high range) < 1 to 25% (low range)Intra-Assay CV: 3 – 5%Inter-Assay CV: 4 – 7%
Reference Material : FVIII:C International Standard
Intended use : Diagnosis of congenital or acquired FVIII:C deficiencies (hemophilia A).Follow-up of FVIII:C recovery in treated patients.Measurement of high FVIII:C concentrations
IVD
FVIII:C activity
13
ZYMUTEST Anti-VIII Mono-strip, IgGFactor VIII Antibody Immunoassay #RK039A
The ZYMUTEST anti-VIII, IgG, a qualitative or quantitative Monostrip ELISA kit, is a standardised and optimised enzyme immuno-assay designed for measuring auto and allo-antibodies to Factor VIII, of the IgG isotype, in human plasma or serum or in any biological fluid where auto-antibodies to FVIII can be present.
IgM or IgA isotypes are not measured.
Pres
enta
tion
4 individual 8 well strips2x Sample Diluent4x Anti-FVIII, IgG, Positive control4x Negative control4x Anti-IgG (Fc)-HRP IC1x Conjugate Diluent2x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h15Intra-Assay CV: < 8%Inter-Assay CV: < 10%Semi quantitative Possibility of quantitation
Intended use : Assay proposed for the measurement of anti-VIII antibodies in research applications.
Auto-Antibodies to Factor VIII:C
RUO
Biophen® Factor IXFactor IX Chromogenic Assay #221802 / #221805
Chromogenic assay (high and low range) for measuring Factor IX activity in human citrated plasma (or in Factor IX concentrates), using a chromogenic method, manual or automated.
For purified Factor IX or concentrates, a pre-dilution in Factor IX deficient plasma is recommended.
Pres
enta
tion
R1: FX, and FVIII:CR2: FXIa (h), h Thrombin, calcium and syntheticPhospholipidsR3: Chromogenic substratespecific for FXa (SXa-11)R4: Tris-BSA Buffer
#221802 (2.5 mL)2x2.5 mL: R1, R2, R32x25 mL: R4#221805 (5 mL)2x5 mL: R1, R2, R34x25 mL: R4
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 10 min.Detection Threshold: 10%Dynamic Range: 10 – 100 ng/mLHigh Dynamic Range 20-200%Low Dynamic Range: 0.5-20%Intra-Assay CV: 3 - 5%Inter-Assay CV: 4 – 6%Reference Material: NIBSC International standard
Intended use : Assay proposed for the measurement of Factor IX activity in research applications.
ZYMUTEST Factor IXFactor IX Immunoassay #RK032A
Two-site ELISA method for the measurement of coagulation Factor IX, in human citrated plasma. Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x FIX Calibrator1x high & low FIX controls3x Anti-h-FIX-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs Total Assay Time: 1h05 (one step method)Detection Threshold: ≤ 5%Dynamic Range: 0 to 100 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%No Significant interference of Heparin up to 2 IU/mL
Reference Material : NIBSC International Standard
Intended use : Assay proposed for the measurement of Factor IX antigen in research applications.
Factor IX Activity and Antigen
RUO
RUO
14
Biophen® Factor IXa (Act FIX) Activated Factor IX (FIXa) Chromogenic Assay #221812
Chromogenic assay for measuring Factor IXa (Activated Factor IX) activity in human citrated plasma (or in Factor IX concentrates), using a chromogenic method, manual or automated.
For testing Factor IXa in purified Factor IX or concentrates, a pre-dilution in Factor IX deficient plasma or in R4 buffer can be performed.
Pres
enta
tion
R1: 2x2.5 mL FX and FVIII:CR2: 2x2.5 mL h Thrombin,calcium and synthetic PhospholipidsR3: 2x2.5 mL Chromogenicsubstrate specific for FXa (SXa-11)R4: 2x25 mL of Tris-BSA BufferCal: 2x1 mL FIXa Calibrator
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 10 min.Detection Threshold: 0.1 mIU/mL (0.1 ng/mL)Dynamic Range: 3-30 mIU/mLIntra-Assay CV: 3 - 5%Inter-Assay CV: 4 – 6%
Reference Material: NIBSC International Standard for FIXa
Intended use : Assay proposed for the measurement of Factor IXa activity in research applications.
Factor IXa Activity
RUO
Biophen® Factor XFactor X Chromogenic Assay #221705
Chromogenic assay for the quantitative determination of Factor X in human citrated plasma, or in concentrates, using a manual or automated protocol.
Pres
enta
tion
R1: 4x5mg Chromogenic substrate, specific for FXa (SXa-11)R2: 4 vials of highly purifiedFX activating enzyme (RVVextracted from snake venom)R3: 4x5 mL x10 concen-tratedTris-NaCl buffer. Contains sodium azide
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 3 min.Detection Threshold: ≤ 5%Dynamic Range: 5-200%Intra-Assay CV: 3 - 5%Inter-Assay CV: 4 – 7%
Not sensitive to the presence of heparin in plasma up to a concentration of at least 1 IU/mL.
Intended use : Assay proposed for the measurement of Factor X in research applications.
Factor X Activity and AntigenRUO
ZYMUTEST Factor XFactor X Immunoassay #RK033A
Two-site ELISA method for the measurement of coagulation Factor X, in human citrated plasma.
Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker. Pr
esen
tati
on
12x8 test kit2x Sample Diluent3x FX Calibrator1x high & low FX controls3x Anti-h-FX-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 1h05 (One Step Method)
Detection Threshold: ≤ 5%Dynamic Range: 0 to 200 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%
No Significant interference of Heparin up to 2 IU/mL
Reference Material : NIBSC International Standard
Intended use : Assay proposed for the measurement of Factor X antigen in research applications.
RUO
Biophen® FXIaFactor XIa Chromogenic Assay #220412
Chromogenic assay for measuring activated Factor XI (FXIa) activity through Factor IX activation and Factor Xa generation, using a manual or automated protocol.
Pres
enta
tion
R1A: 2x3 mL h FX and FVIII:CR1B: 2x3 mL h FIX(without FIXa)R2: 2x3 mL ActivationreagentR3: 2x3 mL FXa Chro-mogenic substrateR4: 2x25 mL Tris-BSA buffer(Contains sodium azide)R5 2x2 mL FXIa calibrator
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 10 min.Detection Threshold: < 0.25 ng/mLDynamic Range: 0.1 to 5 ng/mLIntra-Assay CV: < 4%Inter-Assay CV: < 6%
Intended use : Assay proposed for the measurement of Factor XIa activity in research applications.
Factor XIa Activity
RUO
15
ZYMUTEST Factor XIIIFactor XIII Immunoassay #RK034A
Two-site ELISA method for the measurement of coagulation human Factor XIII (subunit A) (FXIII-A) in plasma, or in any fluid where FXIII can be present.
Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x FXIII Calibrator1x high & low FXIII controls3x Anti-h-FXIII-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 1h05 (One Step Method)
Detection Threshold: ≤ 10%Dynamic Range: 0 to 200 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%
Intended use : Assay proposed for the measurement of Factor XIII-A in research applications.
ZYMUTEST vWFVon Willebrand Factor Immunoassay CE #RK030A
Two-site ELISA method for the measurement of vWF. Assay designed with specific rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker; contains calibrators, established against the NIBSC International Standard, and controls at 2 levels. This assay is indicated for measuring low (von Willebrand disease) or high (increased thrombotic risk) vWF concentrations in human citrated plasma.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x vWF Calibrator1x high & low vWF plasma controls3x Anti-h-vWF-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 3h05Detection Threshold: ≤ 5%Dynamic Range: 0 to About 150%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%
No Significant interference of Heparin up to 2 IU/mL, Bilirubin up to 0.05 mg/mL, Hemoglobin up to 10 mg/mL
Intended use : Diagnosis of von Willebrand disease (vWD).Assay of vWF in clinical samples, as a disease marker or as an indicator for cardiovascular diseases.
vWF deficiency associated with auto-antibodies to vWF (malignancy).
High vWF concentrations in cardiovascular diseases.
ZYMUTEST CBA (Collagen Binding Assay)Immunoassay for Von Willebrand FactorCollagen Binding Activity
CE #RK038A
The ZYMUTEST vWF:CBA kit is an enzyme-immuno-assay for measuring Collagen Binding Activity (CBA) of human von Willebrand Factor (vWF) in plasma, or in any fluid where this activity needs to be measured.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x vWF Calibrator1x high & low vWF plasma controls3x Anti-h-vWF-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 3h25Detection Threshold: ≤ 5%Dynamic Range: 0 to About 150%Intra-Assay CV: < 10%Inter-Assay CV: < 10%
Intended use : Diagnosis of von Willebrand disease (vWD).
Assay of vWF:CBA in clinical samples, as a disease marker or as an indicator for cardiovascular diseases.
Factor XIII Antigen
Von Willebrand Factor Antigen and Activity
RUO
IVD
IVD
16
Prothrombin Deficient Plasma CE #DP010A / #DP010K
Deficient plasma for the assay of Prothrombin. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FII, which is brought by the diluted tested plasma. Clotting is triggered with calcium thromboplastin. FII is the limiting factor and clotting time is inversely proportional to the concentration of FII.
Pres
enta
tion
Citrated h plasma,deficient for Prothrombin,immuno-depleted, lyophilized in the presence of glycine and stabilizers
1x 1 mL (DP010A)6x 1 mL (DP010K)
Ass
aych
arac
teri
stic
s
Plasma deficient for Prothrombin <1%Other coagulation factors > 50%
Intended use : Measurement of Factor II (FII or Prothrombin) activity in human citrated plasma using a clotting method, triggered with calcium thromboplastin.For any in vitro protocol or research study where a source of human Prothrombin deficient plasma is required
Deficient Plasmas, Immuno Depleted
IVD
Human citrated, immunodepleted, freeze dried plasmas for clotting assays or research applications where a source of deficient plasma is required. When used for testing coagulation factor activities these deficient plasmas must be used along with a commercially available Prothrombin Time (PT) reagent, for factors II, V, VII, X or with an Activated Partial Thromboplastin Time (APTT) reagent, for factors VIII:C, IX, XI, XII, Prekallikrein and HMW Kininogen.
Factor V Deficient Plasma CE #DP020A / #DP020K
Deficient plasma for the assay of Factor V. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FV, which is brought by the diluted tested plasma. Clotting is triggered with calcium thromboplastin. FV is the limiting factor and clotting time is inversely proportional to the concentration of FV.
Pres
enta
tion
Citrated h plasma, deficient for FV,immuno-depleted, lyophilized in the presence of glycine and stabilizers
1x 1 mL (DP020A)6x 1 mL (DP020K)
Ass
ay
char
acte
rist
ics
Plasma deficient for Factor V <1%Other coagulation factors > 50%
Intended use : Measurement of Factor V (FV or Proaccelerin) activity in human citrated plasma using a clotting method, triggered with calcium thromboplastin.For any in vitro protocol or research study where a source of human FV deficient plasma is required
IVD
Factor VII Deficient Plasma CE #DP030A / #DP030K
Deficient plasma for the assay of Factor VII. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FVII, which is brought by the diluted tested plasma, and clotting is triggered with calcium thromboplastin. FVII is the limiting factor and clotting time is inversely proportional to the concentration of FVII.
Pres
enta
tion
Citrated human plasma, deficient for Factor VII, immuno-depleted, lyophilized in the presence of glycine and stabilizers.
1x 1 mL (DP030A)6x 1 mL (DP030K)
Ass
ay
char
acte
rist
ics
Plasma deficient for FVII <1%Other coagulation factors > 50%
Intended use : Measurement of Factor VII (FVII or Proconvertin) activity in human citrated plasma using a clotting method, triggered with calcium thromboplastin.For any in vitro protocol or research study where a source of human FVII deficient plasma is required.
IVD
Factor VIII:C Deficient Plasma CE #DP040A / #DP040K
Deficient plasma for the assay of Factor VIII:C. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FVIII:C, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (APTT). FVIII:C is the limiting factor and clotting time is inversely proportional to the concentration of FVIII:C.
Pres
enta
tion
Citrated human plasma, deficient for Factor VIII:C, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.
1x 1 mL (DP040A)6x 1 mL (DP040K)
Ass
ay
char
acte
rist
ics
Plasma deficient for FVIII:C <1%Other coagulation factors > 50%
Intended use : Measurement of Factor VIII:C (FVIII:C) activity in human citrated plasma using a clotting method, in the presence of cephalin, activator and calcium (APTT reagent).For any in vitro protocol or research study where a source of human FVIII:C deficient plasma is required.
Factor IX Deficient Plasma CE #DP050A / #DP050K
Deficient plasma for the assay of Factor IX. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FIX, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (APTT). Pr
esen
tati
on
Citrated human plasma, deficient for Factor IX, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.
1x 1 mL (DP050A)6x 1 mL (DP050K)
Ass
ay c
hara
cter
isti
cs
Plasma deficient for FIX <1%Other coagulation factors >50%
Intended use : Measurement of Factor IX (FIX) activity in human citrated plasma using a clotting method, in the presence of cephalin, activator and calcium (APTT reagent).For any in vitro protocol or research study where a source of human FIX deficient plasma is required.
Factor X Deficient Plasma CE #DP060A / #DP060K
Deficient plasma for the assay of Factor X. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FX, which is brought by the diluted tested plasma, and clotting is triggered with calcium thromboplastin. FX is the limiting factor and clotting time is inversely proportional to the concentration of FX.
Pres
enta
tion
Citrated human plasma, deficient for Factor X, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.
1x 1 mL (DP060A)6x 1 mL (DP060K)
Ass
ay
char
acte
rist
ics
Plasma deficient for FX <1%Other coagulation factors >50%
Intended use : Measurement of Factor X (FX or Stuart Factor) activity in human citrated plasma using a clotting method, triggered with calcium thromboplastin.For any in vitro protocol or research study where a source of human FX deficient plasma is required
Factor XI Deficient Plasma CE #DP070A / #DP070K
Deficient plasma for the assay of Factor XI. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FXI, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (APTT). FXI is the limiting factor and clotting time is inversely proportional to the concentration of FXI.
Pres
enta
tion
Citrated human plasma, deficient for Factor XI, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.
1x 1 mL (DP070A)6x 1 mL (DP070K)
Ass
ay
char
acte
rist
ics
Plasma deficient for FXI <1%Other coagulation factors >50%
Intended use : Measurement of Factor XI (FXI or factor Rosenthal) activity in human citrated plasma using a clotting method, in the presence of cephalin, activator and calcium (APTT reagent).For any in vitro protocol or research study where a source of human FXI deficient plasma is required
IVD
IVD
IVD
IVD
17
18
Factor XII Deficient Plasma CE #DP080A / #DP080K
Deficient plasma for the assay of Factor XII. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FXII, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (APTT). FXII is the limiting factor and clotting time is inversely proportional to the concentration of FXII.
Pres
enta
tion
Citrated human plasma,deficient for Factor XII,immuno-depleted, lyo-philized in the presence of glycine and stabilizers.
1x 1 mL (DP080A)6x 1 mL (DP080K)
Ass
ay c
hara
cter
isti
cs
Plasma deficient for FXII <1%Other coagulation factors > 50%
Intended use : Measurement of Factor XII (FXII or factor Hageman) activity in human citrated plasma using a clotting method, in the presence of cephalin, activator and calcium (APTT reagent).For any in vitro protocol or research study where a source of human FXII deficient plasma is required.
Factor XIII Deficient Plasma #DP200A / #DP200K
Deficient plasma for Factor XIII.
Pres
enta
tion
Citrated human plasma,deficient for FXIII,immuno-depleted, lyo-philized in the presence of glycine and stabilizers.
1x 1 mL (DP200A)6x 1 mL (DP200K)
Ass
aych
arac
teri
stic
sPlasma deficient for FXIII <1%Other coagulation factors > 50%
Intended use : For any in vitro protocol or research study where a source of human FXIII deficient plasma is required.
Kininogen Deficient Plasma #DP300A / #DP300K
Deficient plasma for Kininogen.
Pres
enta
tion
Citrated human plasma, deficient for Kininogen, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.
1x 1 mL (DP300A)6x 1 mL (DP300K)
Ass
aych
arac
teri
stic
s
Plasma deficient for Kininogen <1%Other coagulation factors > 50%
Intended use : For any in vitro protocol or research study where a source of human Kininogen deficient plasma is required.
IVD
RUO
RUO
Prekallikrein Deficient Plasma #DP310A / #DP310K
Deficient plasma for Prekallikrein.
Pres
enta
tion
Citrated human plasma, deficient for Prekallikrein, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.
1x 1 mL (DP310A)6x 1 mL (DP310K)
Ass
aych
arac
teri
stic
s
Plasma deficient for Prekallikrein <1%Other coagulation factors > 50%
Intended use : For any in vitro protocol or research study where a source of human Prekallikrein deficient plasma is required.
RUO
19
Protein S Deficient Plasma #DP110A / #DP110K
Deficient plasma for Protein S.
Pres
enta
tion
Citrated human plasma, deficient for Protein S, im-muno-depleted, lyophilized in the presence of glycine and stabilizers.
1x 1 mL (DP110A)6x 1 mL (DP110K)
Ass
aych
arac
teri
stic
s Plasma deficient for Protein S <1%Other coagulation factors > 50%
Intended use : For any in vitro protocol or research study where a source of human Protein S deficient plasma is required.
RUO
Protein Z Deficient Plasma #DP120A / #DP120K
Deficient plasma for Protein Z.
Pres
enta
tion
Citrated human plasma, deficient for Protein Z, immu-no-depleted, lyophilized in the presence of glycine and stabilizers.
1x 1 mL (DP120A)6x 1 mL (DP120K)
Ass
aych
arac
teri
stic
s Plasma deficient for Protein Z <1%Other coagulation factors > 50%
Intended use : For any in vitro protocol or research study where a source of human Protein Z deficient plasma is required.
RUO
tPA/PAI-1 Deficient Plasma #DP210A / #DP210K
Deficient plasma for tPA and PAI-1.
Pres
enta
tion
Citrated human plasma, deficient for tPA/PAI-1, immu-no-depleted, lyophilized in the presence of glycine and stabilizers.
1x 1 mL (DP210A)6x 1 mL (DP210K)
Ass
aych
arac
teri
stic
s Plasma deficient for tPA and PAI-1 Ag <1ng/mLPlasma deficient for PAI-1 activity <1ng/mLOther coagulation factors > 50%
Intended use : For any in vitro protocol or research study where a source of human tPA/PAI-1 deficient plasma is required.
RUO
vWF Deficient Plasma #DP150A / #DP150K
Deficient plasma for vWF.
Pres
enta
tion
Citrated human plasma, deficient for vWF, immuno-depleted, lyophilized in the presence of glycine and stabilizers.
1x 1 mL (DP150A)6x 1 mL (DP150K)
Ass
ay
char
acte
rist
ics Plasma deficient for vWF <1%
Other coagulation factors >50%
Intended use : For any in vitro protocol or research study where a source of vWF deficient plasma is required.
RUO
Calibrators and ControlsRefer to page 43
Protein C Deficient Plasma #DP100A / #DP100K
Deficient plasma for Protein C.
Pres
enta
tion
Citrated human plasma,deficient for Protein C,immuno-depleted, lyo-philized in the presence of glycine and stabilizers.
1x 1 mL (DP100A)6x 1 mL (DP100K)
Ass
aych
arac
teri
stic
s Plasma deficient for Protein C <1%Other coagulation factors > 50%
Intended use : For any in vitro protocol or research study where a source of human Protein C deficient plasma is required.
RUO
PART 3 :THROMBOPHILIA
Measurement of plasma proteins controlling thrombosis and exhibiting antithrombotic properties (PC, PS, AT, etc...).
20
21
Biophen® AntithrombinAntithrombin (Anti-Xa) Chromogenic Assay CE 510(k) #221102 / #221105
Chromogenic assay for the measurement of antithrombin (AT) activity in human plasma, with an anti-Xa method. Automatic or manual method.
Pres
enta
tion
R1: Bovine Factor XaR2: Chromogenic substrate,specific for Factor Xa (SXa-11)R3 : Tris-Heparin Buffer
#2211022x2.5 mL: R1, R22x5 mL: R3
#2211054x5 mL: R1, R24x10 mL: R3
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 3 min.Detection Threshold: ≤ 5%Dynamic Range: 0 to 100%Intra-Assay CV: < 3%Inter-Assay CV: < 5%No known drug interference in the assay.No interference of Heparin Cofactor II, a2-acroglo-bulin or a1-Antitrypsin.No interference for hemoglobin concentrations up to 5 mg/mL, for Bilirubin concentrations up to0.1 mg/mL, and for plasma from hyperlipaemic patients.
Intended use : Diagnosis of congenital or acquired Antithrombin deficiencies.Measurement of ATIII activity in biological milieu or purified fractions.
Biophen® AT (LRT)Antithrombin Chromogenic Assay (anti-Xa)(Liquid technonogy)
CE #221111
Chromogenic assay for the measurement of antithrombin (AT) activity in human plasma, with an anti-Xa method. Liquid Reagent Technology(LRT).
Pres
enta
tion
All reagents are in the liquid presentation and ready to use
R1: 4x11 mL Bovine Factor Xa
Liquid ReagentTechnology (LRT).
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 3 min.Detection Threshold: ≤ 15%Dynamic Range: 0 to 100%Intra-Assay CV: < 3%Inter-Assay CV: ≤ 5%
No interference of Heparin Cofactor II, a2-macroglo-bulin or a1-Antitrypsin.
Intended use : Diagnosis of congenital or acquired Antithrombin deficiencies.Measurement of ATIII activity in biological milieu or purified fractions.
Biophen® AT (Anti-IIa)Antithrombin (Anti-IIa) Chromogenic Assay CE #221122
Chromogenic assay for the measurement of antithrombin (AT) activity in human plasma, with an anti-IIa method, in presence of an excess of heparin. All the reagents are optimized and ready to use, and are reconstituted with distilled water.
The assay of choice for measuring AT III based anti-IIa activity in plasma or concentrates.
Pres
enta
tion
R1: 2x2.5 mL Bovine Thrombin
R2: 2x2.5 mL Chromogenic substrate specific for Thrombin
R3: 2x25 mL Sample Diluent with heparin A
ssay
cha
ract
eris
tics
Total Assay Time: < 3 min.Detection Threshold: ≤ 15%Dynamic Range: 0 to 100%Intra-Assay CV: < 3%Inter-Assay CV: ≤ 5%
No interference of Heparin Cofactor II, a2-macroglo-bulin or a1-Antitrypsin.
Intended use : Diagnosis of congenital or acquired Antithrombin deficiencies.Measurement of ATIII activity in biological milieu or purified fractions.
Antithrombin III Activity and Antigen
IVD
IVD
IVD
PART 3 : THROMBOPHILIA
PART
3 :
THRO
MBO
PHIL
IA
22
Biophen® Protein CProtein C Chromogenic Assay CE 510(k) #221202 / #221205
Chromogenic assay for the measurement of Protein C (PC) activity in human plasma, following activation with Protac®, a specific enzymatic activator extracted from snake venom (Agkistrodon C. Contortrix). Automatic or Manual method.
Pres
enta
tion
R1: Protac®
R2: Chromogenic subs-trate, specific for Activated protein C (SaPC-21)
#2212023x2.5 mL: R13x4 mg: R2
#2212054x5 mL: R14x8 mg: R2
Ass
ay c
hara
cter
isti
cs
Total Assay Time: ≤ 10 min.Detection Threshold: ≤ 5%Dynamic Range: 0 to 100 %Intra-Assay CV: < 3%Inter-Assay CV: < 5%
No significant interference observed for heparin concentrations < 1 IU/mL, Bilirubin concentrations < 0.1 mg/mL, hemoglobin concentrations <1 mg/mL and triglycerides concentrations <1.25 mg/mL.
Intended use : Diagnosis of congenital or acquired Protein C deficiencies.Protein C concentrates.
Biophen® Protein C (LRT) Protein C Chromogenic Assay(Liquid Technology)
CE #221211
Chromogenic assay for the measurement of Protein C (PC) activity in human plasma, following activation with Protac®, a specific enzymatic activator extracted from snake venom (Agkistrodon C. Contortrix). Automatic or Manual method.
Liquid Reagent Technology (LRT): all the reagents are in the liquid presentation. Ready to use.
Pres
enta
tion
R1: Protac®
R2: Chromogenic subs-trate, specific for Activa-ted protein C (SaPC-21)
3x3 mL
Ass
ay c
hara
cter
isti
cs
Total Assay Time: ≤ 10 min.Detection Threshold: ≤ 5%Dynamic Range: 0 to 100 %Intra-Assay CV: < 3%Inter-Assay CV: < 5%
No significant interference observed for heparin concentrations < 1 IU/mL, Bilirubin concentrations < 0.1 mg/mL, hemoglobin concentrations <1 mg/mL and triglycerides concentrations<1.25 mg/mL.
Intended use : Diagnosis of congenital or acquired Protein C deficiencies.Protein C concentrates.
Protein C Activity and Antigen
IVD
IVD
LIAPHEN AT Antithrombin Latex Immunoassay CE #120002
Latex immunoassay for measuring Antithrombin (AT) in human citrated plasma or in purified milieu, using a manual or automated method, in vitro exclusively.
Pres
enta
tion
R1: 2x2 mL Latex reagent
R2: 2x10 mL Reaction Buffer
Ass
ay c
hara
cter
isti
cs
Total Assay Time: <10 min.Detection Threshold: ≤ 5%Dynamic Range: 0 to 150 %Intra-Assay CV: < 4%Inter-Assay CV: < 6%No hook effect is observed for ATIII concentrations ≤ 200% (7.5µg/ml of purified ATIII).
No interference is observed for Unfractionated and Low Molecular Weight Heparin concentrations ≤ 2 IU/ml added in plasma.
The presence of rheumatoid factor may result in an overestimation of the ATIII concentration.
Intended use : Assay of ATIII in human citrated plasma.AT concentrates
IVD
23
HEMOCLOT Protein CProtein C Clotting Assay CE # CK031K
Protein C is measured with a clotting method, following activation with Protac®, a specific activating enzyme extracted from snake venom (Agkistrodon C. Contortrix), in Protein C deficient plasma.
Pres
enta
tion
R1: 3x1 mL Protein C deficient plasma
R2: 3x1 mL Protein CActIvator (Protac®)
Ass
ay c
hara
cter
isti
cs Total Assay Time: 8 min.Detection Threshold: 10%Dynamic Range: 0 to 200%Intra-Assay CV: < 7%Inter-Assay CV: 5-8 %
No interference of heparin up to 1 IU/mL
Intended use : Diagnosis of congenital or acquired Protein C deficiencies.Protein C concentrates.
ZYMUTEST Protein CProtein C Immunoassay CE #RK027A
Two-site ELISA method for the measurement of coagulation Protein C, in human citrated plasma.
Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Plasma PC Calibrator1x high & low PC controls3x Anti-h-PC-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
csTotal Assay Time: 2h15 (Two Step Method)Detection Threshold: ≤ 5%Dynamic Range: 0 to About 130%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%
No Significant interference of Heparin up to 2 IU/mL, Bilirubin up to 0.05 mg/mL, hemoglobin up to 5 mg/mL
No interference of rheumatoid factorNo prozone effect observed for PC concentration up to 100 µg/mL Assay calibrated against the NIBSC International Standard for PC
Intended use : Diagnosis of congenital or acquired Protein C deficiencies.Protein C concentrates.
Protein S Activity and Protein S Free and Total Antigens
HEMOCLOT Protein S Protein S Clotting Assay CE
# CK041K
Clotting assay for Protein S anticoagulant activity : Protein S is measured with a clotting method using a Protein S deficient plasma, and coagulation is initiated with FIXa in presence of Activated Protein C (APC) in excess and calcium.
Pres
enta
tion
R1: 3x1 mL Protein S deficient plasma
R2: 3x1 mL Activator reagent
Ass
ay c
hara
cter
isti
cs Total Assay Time: 5 min.Detection Threshold: 10%Dynamic Range: 0 to 100%Intra-Assay CV: < 7%Inter-Assay CV: < 10%
No interference of heparin up to 1 IU/mL
Intended use : Diagnosis of congenital or acquired Protein S deficiencies, associated with an increase risk of thrombosis.
IVD
IVD
IVD
24
ZYMUTEST Free Protein S Free Protein S Immunoassay CE #RK015A
Two-site ELISA method for the measurement of free Protein S (form which supports the anticoagulant activity), in human citrated plasma.
Assay designed with two conformational Murine monoclonal antibodies, calcium dependent, the first one for coating the microplate (immunocapture) and the second one, labelled with a Horse Radish Peroxidase (HRP) marker.
Pres
enta
tion
12x8 test kit2x PS Sample Diluent3x Plasma PS Calibrator1x high & low PS controls3x Anti-h-Free PS-HRP IC1x PrS Conjugate Diluent1x PS Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 1h15 (One Step Method)Detection Threshold: ≤ 5%Dynamic Range: 0 to about 100%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%
No Significant interference of Heparin up to 2 IU/mL, Bilirubin up to 0.1 mg/mL, Hemoglobin up to 10 mg/mL
Reference Material : International Standard for PS (93/950) and normal plasma pools
Intended use : Diagnosis of Protein S deficiencies (congenital, acquired or transitory).• Type I deficiency: Partial deficiency of total and Free Protein S antigen.• Type II deficiency: Normal total and Free Protein S antigen, reduced activity.• Type III deficiency: Normal total antigen, decreased activity and free antigen.
Assay of Protein S in clinical studies.
ZYMUTEST Total Protein S Total Protein S Immunoassay CE #RK021A
Two-site ELISA method for the measurement of total Protein S (free or complexed with C4b-BP), in human citrated plasma.
Assay designed with two conformational Murine monoclonal antibodies, calcium dependent, the first one for coating the microplate (immunocapture) and the second one, labelled with a Horse Radish Peroxidase (HRP) marker.
Pres
enta
tion
12x8 test kit2x PS Sample Diluent3x Plasma PS Calibrator1x high & low PS controls3x Anti-h-Total PS-HRP IC1x PS Conjugate Diluent1x PS Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 1h15 (One Step Method)Detection Threshold: ≤ 5%Dynamic Range: 0 to about 100%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%
No Significant interference of Heparin up to 2 IU/mL Bilirubin up to 0.1 mg/mL Hemoglobin up to 10 mg/mLReference Material : International Standard for PS (93/950) and normal plasma pools
Intended use : Diagnosis of Protein S deficiencies (congenital, acquired or transitory).• Type I deficiency: Partial deficiency of total and Free Protein S antigen.• Type II deficiency: Normal total and Free Protein S antigen, reduced activity.• Type III deficiency: Normal total antigen, decreased activity and free antigen.
Assay of Protein S in clinical studies.
IVD
IVD
Protein Z Antigen
ZYMUTEST Protein Z Protein Z Immunoassay #RK031A
Two-site ELISA method for the measurement of coagulation Protein Z, in human citrated plasma.
Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker. Pr
esen
tati
on
12x8 test kit2x Sample Diluent3x PZ Calibrator1x high & low PS controls3x Anti-h-PZ-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 1h15 (One Step Method)
Detection Threshold: ≤ 0.25 µg/mLDynamic Range: 0 to 5 µg/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%
No Significant interference of Heparin up to 2 IU/mL Assay calibrated using a well characterized and highly purified human Protein Z preparation.
Intended use : Assay proposed for the measurement of Protein Z in research applications.
RUO
25
HEMOCLOT Factor V-LFactor V-L Clotting Assay (Qualitative) CE #CK061K /# CK061L
Variant assay for measuring the Resistance of Factor V (Factor V-Leiden is resistant) to its inactivation by Activated Protein C (APC), in human plasma, using a clotting method. Assay fully designed with purified proteins and enzymes. It offers a well defined identification of heterozygous or homozygous patients carrying the factor V-Leiden mutation. The clotting time of diluted plasma is assayed with or without APC, and the ratio is calculated. Normal plasmas have a ratio > 2.00.
Pres
enta
tion
R1: Clotting mixture R2A: Purified h FXR2B: Purified h FX, contai-ning h APCR3: Purified h FIXa
#CK061K2x4 mL: R1,R32x1 mL: R2A, R2B
#CK061L4x4 mL: R1,R34x1 mL: R2A, R2B
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 10 min.Detection Threshold: ratio= 2Dynamic Range: ratio= 1 to >2.5Intra-Assay CV: < 3%Inter-Assay CV: < 5%Number of tests: 2x20 tests (CK061L)
4x20 tests (CK061K)
Intended use : Measurement of FV-L by its resistance to the action of Activated Protein C (APC).Clotting time is measured without or with APC.
IVD
HEMOCLOT Quanti. V-LFactor V Clotting Assay (Quantitative) CE 510(k) #CK065K
Clotting method for the quantitative measurement of Factor V-L (Factor V Leiden) concentration in citrated plasma, by its resistance to the action of Activated Protein C (APC). The assay is performed in the presence of Activated Protein C and Protein S (one single test for each patient). In the presence of APC, the prolongation of clotting time is an inverse relationship of the concentration of Factor V-Leiden (mutation R506Q). Normal Factor V is not measured.
Pres
enta
tion
R1: 3x2 mL Clotting mixture (h-Fibrinogen, h-Prothrombin and Protein S)
R2: 3x1 mL FXa andPhospholipids
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 5 min.Detection Threshold: < 1%Dynamic Range: 0 to 100%Intra-Assay CV: < 3%Inter-Assay CV: < 5%Number of tests: 3x20 tests
No Significant interference of Heparin, Bilirubin, Hemoglobin
Intended use : Quantitative measurement of FV-L, resistant to the action of Activated Protein C, for diagnosing patients carrying the R506Q FV mutation (Factor V-Leiden), or any FV mutant resistant to APC.
IVD
Biophen® H-CoIIHeparin CoFactor II Chromogenic Assay #221902
Chromogenic assay for measuring the Heparin Cofactor II inhibitory activity to Thrombin in presence of Dermatan Sulfate. Highly specific and insensitive to AT III presence.
Pres
enta
tion
R1: 2x2.5 mL humanThrombin
R2: 2x2.5 mL specificThrombin Chromogenicsubstrate
R3: 2x25 mL reaction buf-fer containing Dermatan Sulfate A
ssay
cha
ract
eris
tics Total Assay Time: < 5 min.
Detection Threshold: 0.05 IU/mLDynamic Range: 0 to 1 IU/mLIntra-Assay CV: < 3%Inter-Assay CV: < 5%
Intended use : Assay proposed for the measurement of Heparin Cofactor II in research applications.
RUO
Heparin Cofactor II Activity
Factor V-L (involved in APC-Resistance)
26
HEMOCLOT LA SCREENdRVVT Based Clotting assay for Lupus Anticoagulant(Screening)
CE #CK090K
DRVVT based assay for Lupus anticoagulant: Diluted Russell’s Viper Venom clotting Test (DRVVT) performed in presence of low (screening) phospholipid concentrations for the measurement of Lupus Anticoagulant activity in citrated plasma.
Pres
enta
tion
6x1 mL
Ass
ay c
hara
cter
isti
cs Total Assay Time: < 3 min.Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: ≥ 60
Intended use : Diagnosis of Lupus Anticoagulant using the dRVVT clotting assay.
IVD
Lupus anticoagulant
ZYMUTEST FPA (Fibrino-Peptide A) Fibrino-Peptide A Immunoassay #RK016A
Competitive Enzyme Linked Immuno Assay (CELIA) of Fibrino-Peptide A (FPA), for measuring FPA on Bentonite adsorbed human plasma or any biological sample where FPA must be measured. If tested sample contains fibrinogen, it must be removed (i.e. Bentonite adsorption), in order to avoid any cross-reactivity. The kit contains all the necessary reagents for the assay, and particularly the Bentonite suspension and the anticoagulant solution. All the reagents are ready to use and the MicroELISA plate is already precoated with synthetic human FPA and stabilized.
Pres
enta
tion
12x8 test kit1x Sample Diluent1x Bentonite suspension, ready to use1x 2% Tween 20 , ready to use3x FPA Calibrator3x Rabbit antibodies specific for h-FPA.3x Anti-rabbit-IgG-HRP IC1x Anticoagulant solution1x Conjugate Diluent1x Wash Solution1xTMB1x0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 3h00Detection Threshold: 0.5 ng/mLDynamic Range: 0.5 to 50 ng/mLIntra-Assay CV: 4-7%Inter-Assay CV: 5-10%
Intended use : Assay proposed for the measurement of FPA in research applications.
RUO
Thrombin Generation (release of FPA)
ZYMUTEST DDimer DDimer Immunoassay # RK023A
Two-site ELISA method for the measurement of DDimer in human plasma. Assay designed with two Murine monoclonal antibodies, the first one highly specific for human DDimer, is used for coating the ELISA plate and the second one, conjugated with a Horse Radish Peroxidase (HRP) marker. The assay includes a calibrator and two controls (normal or pathological). Normal ranges are < 400 µg/mL. DDimer concentrations are expressed as “Fibrinogen Equivalent Unit” (FEU).
Pres
enta
tion
12x8 test kit2x Sample Diluent3x DDimer Calibrator1x high & low Plasma DDimer controls3x Anti-h-DDimer-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Detection Threshold: 2 ng/mLDynamic Range: 0 to 200 ng/mLIntra-Assay CV: < 5%Inter-Assay CV: < 8%
Intended use : Assay proposed for the measurement of D-Dimer in research applications.
RUO
Pathological markers
D-Dimer
HEMOCLOT LA CONFIRMdRVVT Based Clotting assay for Lupus Anticoagulant(Confirmation)
CE#CK091K
DRVVT based assay for Lupus anticoagulant: Diluted Russell’s Viper Venom clotting Test (DRVVT) performed in presence of high (confirmation) phospholipid concentrations for the measurement of Lupus Anticoagulant activity in citrated plasma. Pr
esen
tati
on
6x1 mL
Ass
ay c
hara
cter
isti
cs Total Assay Time: < 3 min.Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: ≥ 60
Intended use : Confirmation of Lupus Anticoagulant using the dRVVT clotting assay in presence of an excess of phospholipids.
IVD
27
ZYMUPHEN MP-TF Bio-Immunoassay for ProcoagulantMicroparticles exposing Tissue Factor
#521196
Functional assay for the measurement of procoagulant activity of microparticles exposing Tissue Factor (TF) in human plasma, in vitro, using automated or manual method.
Pres
enta
tion
All the necessary relipida-ted (h) TF for measuring TF-exposing microparticles on a micro Elisa plate coated with anti-(h) TF monoclonal antibodies.
Ass
ay c
hara
cter
isti
cs Total Assay Time: < 3hDetection Threshold: < 50 pg/mLDynamic Range: 0-1000 pg/mLIntra-Assay CV: < 8%Inter-Assay CV: < 10%
Intended use : Assay proposed for the measurement of procoagulant activity of microparticles exposing Tissue Factor in research applications.
RUO
ZYMUPHEN MP-Activity Bio-Immunoassay for ProcoagulantMicroparticles in Plasma
#521096
Functional assay for the measurement of microparticles’ procoagulant activity in human plasma (through thrombin generation) using automated or manual method.
Pres
enta
tion
12x8 test kit (coated with Annexin V)2x Sample DiluentR1: 2x Bovine FXa-FVa mixtureR2: 2x purified h FIIR3: 2x Thrombin specific Chromogenic substrate2x Calibrator1x Control (CI & CII)1x Wash Solution1x 2% Citric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 1h25Detection Threshold: ≤ 0.05 nMDynamic Range: 0 to 50 nMIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%
Intended use : Assay proposed for the measurement of microparticles’ procoagulant activity in research applications.
RUO
Microparticles
28
PART 4 : ANTICOAGULANT DRUGS
. Measurement of Heparins in plasma or in purifi ed milieus, using Anti-Xa or Anti-Ila assays, one or two stages.
. Heparin Induced Thrombocytopenia Measurement.
. New Oral Anticoagulants (NOACs) in plasma (DTIs, DiXals).
29
PART
4 :
AN
TICO
AG
ULA
NT
DRU
GS
HEPARIN
Biophen® HeparinHeparin Chromogenic Assay, Anti-Xa, Kinetics CE 510(k)* #221003 / #221006
Chromogenic anti-Xa method for measuring homogeneously heparin (UFH) and Low Molecular Weight Heparin (LMWH), using the same calibration curve (kinetics method, one stage).
The assay can also be used for testing heparin analogues, such as Sodium Danaparoid (Orgaran®), or Pentasaccharide (Fondaparinux). Automatic or Manual method.
Pres
enta
tion
R1: Chromogenic substratespecific for FXa (SXa-11)
R2: Bovine FXa
#2210033x3.75 mL: R13x3.75 mL: R2
#2210064x7.5 mL: R14x7.5 mL: R2
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 3 min.Detection Threshold: 0.05 IU/mLDynamic Range: 0 to 2 IU/mLIntra-Assay CV: < 3%Inter-Assay CV: < 5%
No significant interference observed for Bilirubin concentrations <0.1 mg/mL, hemoglobin concen-trations <2 mg/mL and triglycerides concentrations <1.25 mg/mL added to plasma.
Intended use : Measuring the heparin concentration in patients’ plasma for monitoring the therapy and adjusting drug dosage.* In US, BIOPHEN Heparin is cleared only for UFH
Biophen® Heparin (AT+)Heparin Chromogenic Assay, Anti-Xa, Kinetics #221007
Chromogenic anti-Xa method for measuring homogeneously heparin and heparin-like anticoagulants, using the same calibration curve (kinetics method, one stage) with addition of exogenous AT III.
The assay can also be used for testing heparin analogues, such as Sodium Danaparoid (Orgaran®), or Pentasaccharide (Fondaparinux). Automatic or Manual method.
Pres
enta
tion
R1: 2x7.5 mL FXasubstrate (SXa-11)
R2: 2x7.5 mL Bovine FXa
R3: 2x2.5 mL AT III
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 3 min.Detection Threshold: 0.05 IU/mLDynamic Range: 0 to 2 IU/mLIntra-Assay CV: < 3%Inter-Assay CV: < 5%
Intended use : Assay proposed for the measurement of heparin in research applications.
Biophen® Heparin (LRT)Heparin Chromogenic Assay, Anti-Xa, Kinetics(Liquid Technology)
CE #221011 / #221013
Chromogenic anti-Xa method for measuring homogeneously heparin (UFH) and Low Molecular Weight Heparin (LMWH), using the same calibration curve (kinetics method, one stage).
The assay can also be used for testing heparin analogues, such as Sodium Danaparoid (Orgaran®), or Pentasaccharide (Fondaparinux). Automatic or Manual method.
Pres
enta
tion
Liquid reagents, ready to use.
R1: FXa substrate (SXa-11)
R2: Bovine FXa
#2210114x7.5 mL: R14x7.5 mL: R2
#2210133x3mL: R13x3mL: R2
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 3 min.Detection Threshold: 0.05 IU/mLDynamic Range: 0 to 2 IU/mLIntra-Assay CV: < 3%Inter-Assay CV: < 5%
Intended use : Measuring the heparin concentration in patients’ plasma for monitoring the therapy and adjusting drug dosage.
Heparin and Heparin Like Substances
IVD
RUO
IVD
PART 4 : ANTICOAGULANT DRUGS
Biophen® Anti-Xa (2 stages)Heparin Chromogenic Assay, Anti-Xa, 2 stages
#221010
Chromogenic anti-Xa method for measuring homogeneously heparin in purified systems or in plasma (tested diluted 1:10) using a two stage method. First, Factor Xa, in excess, is inhibited by heparin in presence of AT III, also in excess (and provided in the assay), then the residual Xa activity is measured by its activity on the specific substrate SXa-11.
This assay meets USP/EP requirements.
Pres
enta
tion
R1: 2x1 mL AT III
R2: 2x1 mL FXa
R3: 2x5 mL FXasubstrate (SXa-11)
R4: 4x25 mL Reaction buffer
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 5 min.Detection Threshold: 0.1 IU/mLDynamic Range: 0 to 2 IU/mL
(0 to 0.2 IU/mL when diluted)Intra-Assay CV: < 3%Inter-Assay CV: < 5%
Intended use : Assay proposed for the measurement of anti-Xa Heparin activity in research applications.
Biophen® Heparin Anti-IIa (Kinetics)Heparin Chromogenic Assay, Anti-IIa, Kinetics
#221020
Chromogenic anti-IIa method for measuring homogeneously heparin in purified systems, using a kinetics/competitive method.
Offers a wide measurement range from 0 to 6 IU/mL and is appropriate for testing heparins for their anti-thrombin activity.
Pres
enta
tion
R1: 2x5 mL AT III
R2: 2x10 mL Thrombin substrate
R3: 2x10 mL Thrombin
R4: 2x20 mL Reaction buffer
Ass
ay c
hara
cter
isti
cs Total Assay Time: < 10 min.Detection Threshold: 0.2 IU/mLDynamic Range: 0 to 6 IU/mLIntra-Assay CV: < 3%Inter-Assay CV: < 5%
Intended use : Assay proposed for the measurement of heparin in research applications.
Biophen® Heparin Anti-IIa (2 stages)Heparin Chromogenic Assay, Anti-IIa, 2 stages
#221025
Chromogenic anti-IIa method for measuring homogeneously heparin in plasma (tested diluted 1:25) or in purified systems, using a two-stage method.
Offers a wide measurement range from 0 to 1 IU/mL for plasma, or from 0.002 to 0.04 IU/mL for purified systems and is appropriate for testing heparins for their anti-thrombin activity.This assay meets USP/EP requirements.
Pres
enta
tion
R1: 2x1 mL AT III
R2: 2x1 mL Thrombin
R3: 2x5 mL Thrombin substrate
R4: 4x25 mL Reaction buffer
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 3 min.Detection Threshold: < 0.1 IU/mLDynamic Range: 0 to 1 IU/mL (0 to 0.04 IU/mL when diluted)Intra-Assay CV: < 3%Inter-Assay CV: < 5%
Intended use : Assay proposed for the measurement of heparin anti-thrombin activity in research applications.
RUO
RUO
RUO
Calibrators and ControlsRefer to page 43
30
ZYMUTEST HIA, IgGELISA for Heparin Induced Antibodies (HIT) CE 510(k) #RK040A
Enzyme Immuno-assay designed for measuring heparin-dependent antibodies of the IgG isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured. This assay measures only the IgG isotype, reported as the most associated with the clinical complications of heparin dependent antibodies (HIT/HITT), allowing confirmation of the diagnosis of HIT/HITT or its clinical suspicion. However, some cases associated with only IgM and/or IgA isotypes can be missed.
Pres
enta
tion
12x8 test kit2x HIA Sample Diluent3x HIA IgG positive Control3x Negative control3x Platelet lysate3x Anti-IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h15Cut-off: A450 > 0.30Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%
Intended use : Clinical suspicion of HIT during heparin therapy.
Heparin-dependent antibodies of the IgG isotype are those strongly associated with the clinical diagnosis of HIT. The ZYMUTEST HIA IgG assay offers then a better specificity for the clinical complication of HIT, but it has less sensitivity as cases associated with only IgM and/or IgA isotypes are missed.
Heparin Induced Thrombocytopenia (HIT)
IVD
ZYMUTEST HIA, IgMELISA for Heparin Induced Antibodies (HIT) CE #RK040B
Enzyme immuno-assay designed for measuring heparin-dependent antibodies of the IgM isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured.
Pres
enta
tion
12x8 test kit2x HIA Sample Diluent3x HIA IgM positive Control3x Negative control3x Platelet lysate3x Anti-IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Cut-off: A450 > 0.30Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%
Intended use : Measurement of human heparin-dependent antibodies of the IgM isotype, in research or prospective studies on the risk of HIT development during heparin therapy.
ZYMUTEST HIA, IgAELISA for Heparin Induced Antibodies (HIT) CE #RK040C
Enzyme immuno-assay designed for measuring heparin-dependent antibodies of the IgA isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured.
Pres
enta
tion
12x8 test kit2x HIA Sample Diluent3x HIA IgA positive Control3x Negative control3x Platelet lysate3x Anti- IgA (a)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Cut-off: A450 > 0.30Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%
Intended use : Measurement of human heparin-dependent antibodies of the IgA isotype, in research or prospective studies on development of HIT during heparin therapy.
IVD
IVD
31
32
ZYMUTEST HIA IgGAMELISA for Heparin Induced Antibodies (HIT),Screening Assay
CE 510(k) #RK040D
Enzyme immuno-assay designed for measuring globally all heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma or serum, or in any biological fluid where these antibodies must be measured. This assay is proposed as screening, as an early identification of heparin treated patients presenting a risk to develop HIT or HITT. This assay measures the whole of antibodies. It offers the highest sensitivity as all isotypes are detected. It is the preferred assay when an early detection of heparin dependent antibodies is required for assessing the development risk of HIT/HITT.
Pres
enta
tion
12x8 test kit2x HIA Sample Diluent3x HIA IgGAM positive Control3x Negative control3x Platelet lysate3x Anti-IgG (Fc)- IgM (m)-IgA(a)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h15Cut-off: A450 ≥ 0.50Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%
Intended use : Assessment of the risk to develop HIT/HITT, in patients treated with heparins (Unfractionated or LMWH): presence of antibodies is a risk indicator for development of HIT/HITT.
Clinical suspicion of HIT during heparin therapy.
IVD
IVDZYMUTEST HIA IgG, IgA, IgMELISA for Heparin Induced Antibodies (HIT), Full isotyping
CE #RK040E
Enzyme immuno-assay designed for specifically measuring heparin-dependent antibodies of IgG, or IgM, or IgA isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured. Specific isotyping assay. Assay designed for the full isotyping of heparin dependent antibodies, applications to characterization of isotype distribution in patients with a risk or a suspicion of HIT/HITT, or for research investigations.
Pres
enta
tion
12x8 test kit2x HIA Sample DiluentPositive Controls (IgG,IgA and IgM)3x Negative control3x Platelet lysateAnti-IgG (Fc)/IgM (µ)/IgA(a)-HRP IC (1 each)1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Cut-off: A450 > 0.30Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%
Note: The kit allows running 32 tests foreach specific isotype.
Intended use : Complete isotyping of Heparin dependent antibodies, as a primary approach in research applications or as a second intention assay for characterizing patients measured positive with the ZYMUTEST HIA IgGAM, screening assay (# RK040D).
ZYMUTEST HIA Mono Strip, IgGELISA for Heparin Induced Antibodies (HIT), IgG isotype, Mono-strip
CE 510(k) #RK041A
Enzyme Immuno-assay designed for measuring heparin-dependent antibodies of the IgG isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured. This assay measures only the IgG isotype, reported as the most associated with the clinical complications of heparin dependent antibodies (HIT/HITT), allowing confirmation of the diagnosis of HIT/HITT or its clinical suspicion. However, some cases associated with only IgM and/or IgA isotypes can be missed.
This kit allows individual test as it offers a packaging for 4 individual 8 well strips along with controls.
Pres
enta
tion
4 individual 8 well strips2x HIA Sample Diluent4x HIA IgG positive Control4x Negative control4x Platelet lysate4x Anti-IgG (Fc)-HRP IC1x Conjugate Diluent2x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Cut-off: A450 > 0.30Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%
Intended use : Individual test.
Clinical suspicion of HIT during heparin therapy.Heparin-dependent antibodies of the IgG isotype are those strongly associated with the clinical diagnosis of HIT.
The ZYMUTEST HIA Mono Strip IgG assay offers then a better specificity for the clinical complication of HIT, but it has less sensitivity as cases associated with only IgM and/or IgA isotypes are missed.
IVD
Mono Strip HIT (4x8 tests)
33
ZYMUTEST HIA Mono strip, IgGAMELISA for Heparin Induced Antibodies (HIT),Screening Assay, Mono-strip
CE 510(k) #RK041D
Enzyme immuno-assay designed for measuring globally all heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma or serum, or in any biological fluid where these antibodies must be measured. This assay is proposed as screening, as an early identification of heparin treated patients presenting a risk to develop HIT or HITT. This assay measures the whole of antibodies. It offers the highest sensitivity as all isotypes are detected. It is the preferred assay when an early detection of heparin dependent antibodies is required for assessing the development risk of HIT/HITT.
This kit allows individual test as it offers a packaging for 4 individual 8 well strips along with controls.
Pres
enta
tion
4 individual 8 well strips2x HIA Sample Diluent4x HIA IgGAM positive Control4x Negative control4x Platelet lysate4x Anti-IgG (Fc)- IgM (m)-IgA(a)-HRP IC1x Conjugate Diluent4x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Cut-off: A450 ≥ 0.50Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%
Intended use : Individual test.
Assessment of the risk to develop HIT/HITT, in patients treated with heparins (Unfractionated or LMWH): presence of antibodies is a risk indicator for development of HIT/HITT.
Clinical suspicion of HIT during heparin therapy.
IVD
34
Biophen® DTIDirect Thrombin Inhibitors (DTI) Chromogenic Assay #220202
Quantitative assay for measuring the anti-IIa activity of Dabigatran and other Direct Thrombin Inhibitors (DTIs) in human citrated plasma, using a chromogenic method, manual or automated.
Pres
enta
tion
R1: 2x2.5 mL ThrombinChromogenic substrate
R2: 2x2.5 mL h Thrombin
R3: 2x25 mL of Tris-BSA Buffer
Ass
ay c
hara
cter
isti
cs Total Assay Time: ≤ 10 min.Detection Threshold: 0.30 µg/ml (high range) 0.15 µg/ml (low range)Dynamic Range: 0 to 5 µg/mL (high range) 0 to 2 µg/mL (low range)Intra-Assay CV: < 5%Inter-Assay CV: < 5%
Intended use : Assay proposed for the measurement of anti-IIa activity in research applications.
Biophen® DiXaI Direct Factor Xa Inhibitor Chromogenic Assay CE #221030
Quantitative assay for measuring the Factor Xa Direct Inhibitor, such as Rivaroxaban in human citrated plasma, using a chromogenic method, manual or automated.
Pres
enta
tion
R1: 3x2.5 mL human FXa
R2: 3x2.5 mL FXaChromogenic substrate
R3: 4x25 mL of Tris-NaCl-EDTA Buffer
Ass
ay c
hara
cter
isti
cs Total Assay Time: ≤ 10 min.Detection Threshold: 0.02 µg/mLDynamic Range: 0 to 0.50 µg/mL Intra-Assay CV: < 5%Inter-Assay CV: <10-15%
Intended use : Measurement of Rivaroxaban and other Factor Xa inhibitors in citrated plasma or other biological fluids.Nota : Biophen® Heparin (3 or 6) or Biophen Heparin LRT can also be used for testing Direct Factor Xa Inhibitors(DiXaIs), such as Rivaroxaban or Apixaban. Adjusted protocols are available on demand.
RUO
IVD
Direct Factor Xa Inhibitors
NEW ORAL ANTICOAGULANTS (NOACs : DTIs ; DiXals)
HEMOCLOT Thrombin InhibitorsDirect Thrombin Inhibitors (DTI) Clotting Assay CE #CK002K / #CK002L
Assay designed for the quantitative measurement of direct thrombin inhibitors (DTI), such as Dabigatran and Argatroban®, in human citrated plasma, with a clotting method based on the inhibition of a constant and defined concentration of thrombin. It is intended for prescription use. Measuring DTI concentrations in patient’s plasma may be used as an aid in the management of patients receiving DTIs who are suspected of having excess anticoagulant activity.
Pres
enta
tion
3x1 mL (CK002K) 3x2.5 mL (CK002L)
R1: normal pooled citra-ted plasma
R2: highly purified humancalcium thrombin (a form)
Ass
ay c
hara
cter
isti
cs
Total Assay Time: < 3 min.Detection Threshold: < 0.1 µg/mLDynamic Range: 0 - 5 µg/mLIntra-Assay CV: < 4%Inter-Assay CV: < 6%
Intended use : Quantitative measurement of Dabigatran, and anti-Thrombin activities in plasma (e.g. Dabigatran Plasma Calibrator (#222801), Dabigatran Control Plasma (#224701), Argatroban® Plasma Calibrator (#SC030K), Argatroban® Control Plasma (#SC035K)).
IVD
Direct Thrombin Inhibitors
35
PART 5 : LUPUS ANTICOAGULANTS AND
ANTI-ANTIPHOSPOLIPID ANTIBODIES (ACA/APA)
PART
5 :
LA, A
CA/A
PA
36
PART 5 : LUPUS ANTICOAGULANTS AND ANTI-ANTIPHOSPOLIPID ANTIBODIES (ACA/APA)
Lupus anticoagulant
HEMOCLOT LA SCREENdRVVT Based Clotting assay forLupus Anticoagulant (Screening)
CE #CK090K
DRVVT based assay for Lupus anticoagulant: Diluted Russell’s Viper Venom clotting Test (DRVVT) performed in presence of low (screening) phospholipid concentrations for the measurement of Lupus Anticoagulant activity in citrated plasma. Pr
esen
tati
on
6x1 mL
Ass
ay c
hara
cter
isti
cs Total Assay Time: < 3 min.Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: ≥ 60
Intended use : Diagnosis of Lupus Anticoagulant using the dRVVT clotting assay.
HEMOCLOT LA CONFIRMdRVVT Based Clotting assay forLupus Anticoagulant (Confirmation)
CE#CK091K
DRVVT based assay for Lupus anticoagulant: Diluted Russell’s Viper Venom clotting Test (DRVVT) performed in presence of high (confirmation) phospholipid concentrations for the measurement of Lupus Anticoagulant activity in citrated plasma. Pr
esen
tati
on
6x1 mLA
ssay
cha
ract
eris
tics Total Assay Time: < 3 min.
Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: ≥ 60
Intended use : Confirmation of Lupus Anticoagulant using the dRVVT clotting assay in presence of an excess of phospholipids.
IVD
IVD
LA-Negative PlasmaNegative Control set for Lupus Anticoagulant CE in progress #SC080K
Negative lyophilized plasmas for LA activity, as measured with the HEMOCLOT LA Screen (ref CK090K) and HEMOCLOT LA Confirm (ref CK091K) kits, for the quality control of Lupus Anticoagulant clotting assays.
Pres
enta
tion
6x1mL
Ass
ay c
hara
cter
isti
cs Negative for LA
High stability following reconstitution.
Intended use : Quality control for Lupus Anticoagulant clotting assays.
LA-Positive PlasmaPositive Control set for Lupus Anticoagulant CE in progress #SC081K
Positive lyophilized plasmas for LA activity, as measured with the HEMOCLOT LA Screen (ref CK090K) and HEMOCLOT LA Confirm (ref CK091K) kits, for the quality control of Lupus Anticoagulant clotting assays.
Pres
enta
tion
6x0.5 mL
Ass
ay c
hara
cter
isti
cs Positive for LA
High stability following reconstitution.
Intended use : Quality control for Lupus Anticoagulant clotting assays.
RUO
RUO
37
ZYMUTEST ACA-APA, IgGImmunoassay for ACA/APA, IgG CE #RK029A
Two-site Enzyme ImmunoAssay (ELISA), designed with Murine monoclonal antibodies, for the quantitative determination of ELISA method for the measurement of IgG isotype auto antibodies targeted to ACA-APA (Anti-Cardiolipin/Anti-Phospholipid-Antibodies). Assay designed with highly characterized and stabilized anionic Phospholipids, saturated with an optimal concentration of a fully active human β2GP1 preparation, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG Fcg fragments, and labelled with peroxidase. Sample Diluent is adjusted for offering the highest sensitivity and specificity.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-Cardiolipin, IgG Calibrator3x Negative Control3x Anti-IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 1h15 Detection Threshold: ≤ 2 GPLNormal Range: ≤ 5 GPLIntra-Assay CV: 3-6%Inter-Assay CV: 4-8%
Optimized specificity and sensitivity (only the “true” antibodies are measured).
Intended use : Anti-Phospholipid Syndrome (APS).Pregnancies with recurrent miscarriage.Unexplained thrombosis.Any clinical situation where the assay of anti-Cardiolipin/Anti-Phospholipid Antibodies is required.
ZYMUTEST ACA-APA, IgMImmunoassay for ACA/APA, IgM CE #RK029B
ELISA method for the measurement of IgM isotype auto antibodies targeted to ACA-APA (Anti-Cardiolipin/Anti-Phospholipid-Antibodies). Assay designed with highly characterized and stabilized anionic Phospholipids, saturated with an optimal concentration of a fully active human β2GP1 preparation, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM µ fragments, and labelled with peroxidase. Sample Diluent is adjusted for offering the highest sensitivity and specificity.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-Cardiolipin, IgM Calibrator3x Negative Control3x Anti-IgM-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 1h15 Detection Threshold: ≤ 1 MPLNormal Range: ≤ 3 MPLIntra-Assay CV: 3-6%Inter-Assay CV: 4-8%
Optimized specificity and sensitivity (only the “true” antibodies are measured)
Intended use : Anti-Phospholipid syndrome (APS).Pregnancies with recurrent miscarriage.Unexplained thrombosis.Any clinical situation where the assay of anti-Cardiolipin/anti-Phospholipid antibodies is required.
IVD
IVD
ZYMUTEST ACA-APA, IgAImmunoassay for ACA/APA, IgA #RK029C
ELISA method for the measurement of IgA isotype auto antibodies targeted to ACA-APA (Anti-Cardiolipin / Anti-Phosphol ipid-Ant ibodies) .Assay designed with highly characterized and stabilized anionic Phospholipids, saturated with an optimal concentration of a fully active human β2GP1 preparation, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgA, a fragments, and labelled with peroxidase. Sample Diluent is adjusted for offering the highest sensitivity and specificity.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-Cardiolipin, IgA Calibrator3x Negative Control3x Anti-IgA-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 1h15 Detection Threshold: ≤ 2 APLNormal Range: ≤ 5 APLIntra-Assay CV: 3-6%Inter-Assay CV: 4-8%
Optimized specificity and sensitivity (only the “true” antibodies are measured).
Intended use : Assay proposed for the measurement of IgA isotype auto antibodies targeted to ACA/APA in research applications.
RUO
Anti-Cardiolipin / Anti-Phospholipid Antibodies (ACA/APA)
38
ZYMUTEST anti-β2GP1, IgGImmunoassay for Anti Beta2 Glycoprotein I, IgG CE #RK014A
ELISA method for the measurement of IgG isotype auto antibodies targeted to β2GP1. Assay designed with highly purified human β2GP1, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG Fc fragments and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-β2GP1, IgG Cali-brator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 1h15
Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
Optimized specificity and sensitivity (only the “true” antibodies are measured).
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Recurrent unexplained miscarriages.Unexplained lupus anticoagulant, without or with thrombosis.Anti-Phospholipid syndrome.Any clinical situation where the assay of anti-b2GP1 auto antibodies is required.
ZYMUTEST anti-β2GP1 IgM Immunoassay for Anti Beta2 Glycoprotein I, IgM CE #RK014B
ELISA method for the measurement of IgM isotype auto antibodies targeted to β2GP1. Assay designed with highly purified human β2GP1, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM µ fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-β2GP1, IgM Cali-brator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 1h15
Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Recurrent unexplained miscarriages.Unexplained lupus anticoagulant, without or with thrombosis.Anti-Phospholipid syndrome.Any clinical situation where the assay of anti-b2GP1 auto antibodies is required.
ZYMUTEST anti-β2GP1, IgA Immunoassay for Anti Beta2 Glycoprotein I, IgA #RK014C
ELISA method for the measurement of IgA isotype auto antibodies targeted to β2GP1. Assay designed with highly purified human β2GP1, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgA, a fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-β2GP1, IgA Cali-brator3x Negative Control3x Anti- IgA (a)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 1h15
Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgA isotype auto antibodies targeted to β2GP1 in research applications.
IVD
IVD
RUO
Anti-β2GP1 Auto-Antibodies
39
ZYMUTEST anti-Annexin V, IgGImmunoassay for Anti-Annexin V, IgG #RK005A
ELISA method for the measurement of IgG isotype auto antibodies targeted to annexin V. Assay designed with highly purified human recombinant annexin V, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-Annexin V, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 2h15
Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Annexin V in research applications.
ZYMUTEST anti-Annexin V, IgMImmunoassay for Anti-Annexin V, IgM #RK005B
ELISA method for the measurement of IgM isotype auto antibodies targeted to annexin V. Assay designed with highly purified human recombinant annexin V, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-Annexin V, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 2h15
Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Annexin V in research applications.
ZYMUTEST anti-Protein C, IgGImmunoassay for Anti-Protein C, IgG #RK026A
ELISA method for the measurement of IgG isotype auto antibodies targeted to protein C. Assay designed with highly purified human protein C, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-PC, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs Total Assay Time: 1h15 Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Protein C in research applications.
RUO
RUO
RUO
Auto-Antibodies to Phospholipid Cofactor Proteins
40
ZYMUTEST anti-Protein C, IgMImmunoassay for Anti-Protein C, IgM #RK026B
ELISA method for the measurement of IgM isotype auto antibodies targeted to protein C. Assay designed with highly purified human protein C, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti- PC, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 1h15
Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Protein C in research applications.
ZYMUTEST anti-Protein S, IgGImmunoassay for Anti-Protein S, IgG #RK020A
ELISA method for the measurement of IgG isotype auto antibodies targeted to protein S. Assay designed with highly purified human protein S, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-PS, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs Total Assay Time: 1h15 Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Protein S in research applications.
ZYMUTEST anti-Protein S, IgMImmunoassay for Anti-Protein S, IgM #RK020B
ELISA method for the measurement of IgM isotype auto antibodies targeted to protein S. Assay designed with highly purified human protein S, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti- PS, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs Total Assay Time: 1h15 Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Protein S in research applications.
RUO
RUO
RUO
ZYMUTEST anti-Protein Z, IgGImmunoassay for Anti-Protein Z, IgG #RK025A
ELISA method for the measurement of IgG isotype auto antibodies targeted to protein Z. Assay designed with highly purified human protein Z, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-PZ, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 1h15 Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Protein Z in research applications.
RUO
41
ZYMUTEST anti-Protein Z, IgMImmunoassay for Anti-Protein Z, IgM #RK025B
ELISA method for the measurement of IgM isotype auto antibodies targeted to protein C. Assay designed with highly purified human protein C, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti- PC, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs Total Assay Time: 1h15 Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Protein Z in research applications.
RUO
ZYMUTEST anti-Prothrombin, IgGImmunoassay for Anti-Prothrombin, IgG #RK007A
ELISA method for the measurement of IgG isotype auto antibodies targeted to Prothrombin. Assay designed with highly purified human Prothrombin, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti-FII, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 2h15
Detection Threshold : ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Prothrombin in research applications.
RUO
ZYMUTEST anti-Prothrombin, IgMImmunoassay for Anti-Prothrombin, IgM #RK007B
ELISA method for the measurement of IgM isotype auto antibodies targeted to Prothrombin. Assay designed with highly purified human Prothrombin, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Anti- FII, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs Total Assay Time: 2h15 Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%
*AU: Arbitrary Unit (Mean + 2SD = 10AU)
Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Prothrombin in research applications.
RUO
42
PART 6 : CALIBRATORS & CONTROLS
Complete line of calibrators and controls, established against WHO International Standards, when available, for the
measurement of the various proteins involved in regulation of blood hemostasis and thrombosis, and for anticoagulant drugs.
43
PAR
T 6
: C
ALI
BR
ATO
RS
AN
D C
ON
TRO
LS
Biophen® Plasma Calibrator Multifactor Plasma Calibrator CE 510(k)* #222101
Calibration plasma for the assay of Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Factors VII+X, Factors II, V, VII, IX, X, XI, XII and Plasminogen.The exact concentration for each factor is indicated on the flyer provided in each kit. Pr
esen
tati
on
12x1 mL of normal citratedhuman pooled plasma
Ass
ay c
hara
cter
isti
cs Normal human citrated plasmas, freeze dried and stabilized, titrated for various factor activities.
Concentrations are established against the NIBSCInternational Standard.
High stability following reconstitution.
Intended use : Calibration plasma for the corresponding clotting or chromogenic assays.
Biophen® Normal Control PlasmaMultifactor Plasma Control, Normal CE 510(k)* #223201
Normal plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors II, V, VII, IX, X, XI, XII and Plasminogen. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit.
Pres
enta
tion
12x1 mL of normal citrated human pooled plasma
Ass
ay c
hara
cter
isti
cs Normal human citrated plasmas, freeze dried and stabilized, titrated for various factor activities.
Concentrations are established against the NIBSCInternational Standard.
High stability following reconstitution.
Intended use : Quality control plasma for the corresponding clotting or chromogenic assays, and for non mutated FV (not resistant to APC).
IVD
IVD
Calibrators and Controls for Plasma Factors and Cofactors
* In US, BIOPHEN Plasma Calibrator is cleared only for calibration of Antithrombin and Protein C assays.
* In US, BIOPHEN Normal Control Plasma is cleared only for calibration of Antithrombin, Protein C, and Factor V-Leiden quantitative assays.
Biophen® FIXa Control SetControl set for FIXa in plasma #224601
Factor IXa Controls are intended for the quality control of activated Factor IX (FIXa) chromogenic measurements, using Biophen® Factor IXa assay(Ref 221812).
Pres
enta
tion
C1: 6x1 mLC2: 6x1 mL
Lyophilized preparation, withstabilizers, supplemented with FIXa
Ass
ay c
hara
cter
isti
cs Normal human plasmas supplemented with FIXa at various levels (level 1 at about 10 mIU/mL / level 2 at about 20 mIU/mL).
Biophen® FIXa Controls are calibrated against an Internal Reference Standard, initially validated by reference to the 1st International Standard for acti-vated Factor IX (FIXa), human (NIBSC) (code 97/562).
High stability following reconstitution.
Intended use : FIXa controls are proposed for the quality control of FIXa measurements, in FIXa therapeutic concentrates or in purified milieus, using Biophen® Factor IXa (#221812).The Ultra Low FIXa control can be used in association with Biophen® FIXa kit (#221812) for testing FIXa in therapeutic concentrates or in purified milieus.
RUO
Biophen® Abnormal Control PlasmaMultifactor Plasma Control, Abnormal CE 510(k)* #223301
Abnormal plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Factors VII+X, Factors II, V, VII, IX, X, XI, XII and Plasminogen. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit.
Pres
enta
tion
12x1 mL of abnormal citrated human pooled plasma
Ass
ay c
hara
cter
isti
cs Abnormal human citrated plasmas, freeze dried and stabilized, titrated for various factor activities.
Concentrations are established against the NIBSCInternational Standard.
High stability following reconstitution.
Intended use : Quality control plasma for the corresponding clotting or chromogenic assay.
IVD
* In US, BIOPHEN Abnormal Control Plasma is cleared only for calibration of Antithrombin and Protein C assays.
44
PART 6 : CALIBRATORS & CONTROLS
45
Biophen® FXIa Control SetControl set for FXIa in plasma #224801
Factor XIa Controls are intended for the quality control of activated Factor XI (FXIa) chromogenic measurements, using Biophen® FXIa colorimetric assay (Ref 220412).
Pres
enta
tion
C1: 3x 1 mL
C2: 3x 1 mL
Lyophilized preparation, with stabilizers, supplemented with FXIa
Ass
ay c
hara
cter
isti
cs
Normal human plasmas supplemented with FXIa at various levels (level 1 at about 1ng/mL / level 2 at about 4 ng/mL).
Biophen® FXIa Controls are calibrated against inter-nal reference standard, initially validated against NIBSC standard reference material, Non WHO 11/236.
High stability following reconstitution.
Intended use : FXIa Controls are proposed for the quality control of FXIa measurements, in therapeutic concentrates or in purified milieus, using Biophen® FXIa kit (#220412)
RUO
Biophen® UFH CalibratorCalibrator set for Unfractionated Heparin in Plasma CE 510(k) #222301
Range of calibration plasmas supplemented with Unfractionated Heparin(UFH) (4 sets at 5 different UFH levels from 0 to 1.40 IU/mL) for the assay of Unfractionated Heparin.
Pres
enta
tion
Human plasma
20 vials (4 sets of 5 vials) of 1 ml human plasma supplemented with different concentrations of Unfractionated Heparin (UFH).
Ass
ay c
hara
cter
isti
cs Normal human plasmas supplemented with UFH at various levels.
Concentrations are established against the NIBSCInternational Standard.
High stability following reconstitution.
Intended use : Calibration set for chromogenic heparin assays (Biophen® Heparin).Specific for UFH.
IVD
Biophen® Heparin CalibratorCalibrator set for Kinetics anti-Xa Assay CE 510(k) #222001
Range of calibration plasmas supplemented with Low Molecular Weight Heparin (LMWH) (4 sets at 5 different heparin levels from 0 to 1.60 IU/ml) for the assay of heparin (UFH or LMWH) using the Biophen® Heparin kit.
Pres
enta
tion
Human plasma
20 vials (4 sets of 5 vials) of 1 ml human plasma supplemented with different concentrations of Low Molecular Weight Heparin (LWMH).
Ass
ay c
hara
cter
isti
cs Normal human plasmas supplemented with LMWH at various levels.
Concentrations are established against the NIBSCInternational Standard.
High stability following reconstitution.
Intended use : Calibration of heparin assays (Biophen® Heparin):LMWH or UFH when Biophen® Heparin is used with a “hybrid calibration curve”.
IVD
Heparin and Analogues
46
Biophen® LMWH Control PlasmaControl set for Low Molecular Weight Heparinin Plasma, High range
CE 510(k) #223001 / #223801 / #224201
Quality control plasmas (2 different levels: about 0.80 and 1.20 IU/mL) for the quality control of LMWH testing (Low Molecular Weight Heparin) in the high concentration range.
Pres
enta
tion
Human plasma
#223001C3: 6x1 mLC4: 6x1 mL
#223801C3: 12x1 mL
#224201C4: 12x1 mL A
ssay
cha
ract
eris
tics Normal human plasmas supplemented with LMWH
at various levels.
Concentrations are established against the NIBSC International Standard.
High stability following reconstitution.
Intended use : Quality control of heparin (LMWH) testing (Biophen® Heparin).High therapeutic range.
IVD
Biophen® LMWH Control LowControl set for Low Molecular Weight Heparinin Plasma, Low range
CE 510(k) #223701 / #224301 / #224401
Quality control plasmas (2 different levels: about 0.25 and 0.50 IU/mL) for the quality control of LMWH testing, in the low concentration range.
Pres
enta
tion
Human plasma
#223701CI: 6x1 mLCII: 6x1 mL
#224301CI: 12x1 mL
#224401CII: 12x1 mL A
ssay
cha
ract
eris
tics Normal human plasmas supplemented with LMWH
at various levels.
Concentrations are established against the NIBSC International Standard.
High stability following reconstitution.
Intended use : Quality control of heparin (LMWH) testing (Biophen® Heparin).Low therapeutic range.
IVD
Biophen® UFH Control PlasmaControl set for Unfrationated Heparin in Plasma CE 510(k) #223101 / #224101 / #223901
Quality control plasmas (2 different levels: about 0.20 and 0.50 IU/mL) for the quality control of UFH testing (Unfractionated Heparin).
Pres
enta
tion
Human plasma
#223101C1: 6x1mLC2: 6x1mL
#224101C1: 12x1 mL
#223901C2: 12x1 mL A
ssay
cha
ract
eris
tics
Normal human plasmas supplemented with UFH at various levels.
Concentrations are established against the NIBSC International Standard.
High stability following reconstitution.
Intended use : Quality control of heparin (UFH) testing (Biophen® Heparin).
IVD
Biophen® Purified UFH Cal.Calibrator set for Unfractionated Heparin inPurified Solution
#222601
Range of calibration solution supplemented with Unfractionated Heparin (UFH) (3 sets at 4 different UFH levels from 0 to 2IU/mL).
Pres
enta
tion
12 vials (3 sets of 4 vials) of 1 ml solution supple-mented with different concentrations of Unfrac-tionated Heparin (UFH).
Ass
ay c
hara
cter
isti
cs Purified solution supplemented with UFH at various levels.
Concentrations are established against the NIBSCInternational Standard.
High stability following reconstitution.
Intended use : Calibration set for chromogenic heparin assays in purified systems.Specific for UFH.
RUO
47
Biophen® Arixtra® Control Plasma Control set for Arixtra® in plasma CE #224001
Quality control plasmas (2 different levels at about 0.40 and 1.20 µg/mL) for the quality control of Arixtra® (Fondaparinux) testing using anti-Xa colorimetric assays.
Pres
enta
tion
12 vials of 1 mL of human plasma supplemented at 2 different concentrations of Arixtra® (6 vials for each concentration).
Ass
ay c
hara
cter
isti
cs Normal human plasmas supplemented with Arixtra® at various levels.
Concentrations are established against a reference preparation for Arixtra®.
High stability following reconstitution.
Intended use : Quality control of Arixtra® testing (Biophen® Heparin).Specific for Arixtra®.
Biophen® Orgaran® ControlControl set for Orgaran® in plasma CE #223501
Quality control plasmas (2 different levels at about 0.50 and 1.00 U/mL) for the quality control of Sodium Danaparoid testing.
Pres
enta
tion
12 vials of 1 ml human plasma supplemented with 2 different concen-trations of Sodium Dana-paroïd (Orgaran®).
Ass
ay c
hara
cter
isti
cs Normal human plasmas supplemented with Orga-ran® at various levels.
Concentrations are established against a reference preparation for Orgaran®.
High stability following reconstitution.
Intended use : Quality control of heparin testing (Biophen® Heparin).Specific for Sodium Danaparoid (Orgaran®).
IVD
IVD
Biophen® Orgaran® CalibratorCalibrator set for Orgaran® in plasma CE #222201
Range of calibration plasmas (4 sets at 5 different Orgaran® levels from 0 to 1.60 U/mL) for the assay of Sodium Danaparoid (Orgaran®).
Pres
enta
tion
20 vials (4 sets of 5 vials) of 1 ml human plasma supplemented with different concentrations of Sodium Danaparoïd (Orgaran®).
Ass
ay c
hara
cter
isti
cs Normal human plasmas at various levels.
Concentrations are established against a reference preparation for Orgaran®.
High stability following reconstitution.
Intended use : Calibration of heparin assays (Biophen® Heparin).Specific for Sodium Danaparoid (Orgaran®).
IVD
Biophen® Arixtra® CalibratorCalibrator set for Arixtra® in plasma CE #222501
Range of calibration plasmas (3 sets at 4 different Arixtra® levels from 0 to 1.50 µg/mL) for the assay of Fondaparinux (Arixtra®).
Pres
enta
tion
12 vials (3 sets of 4 vials) of 1 ml human plasma supplemented with different concentrations of Arixtra®.
Ass
ay c
hara
cter
isti
cs Normal human plasmas at various levels.
Concentrations are established against a reference preparation for Arixtra®.
High stability following reconstitution.
Intended use : Calibration of Arixtra® assays (Biophen® Heparin).Specific for Arixtra®.
IVD
48
Biophen® V-L CAL (Undiluted)Calibrator set for Quantitative Factor V-LClotting Assay (undiluted)
CE 510(k) #222401
Lyophilized, undiluted human plasmas, at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity quantitative clotting assay on human citrated plasma, using the HEMOCLOT Quanti. V-L kit (ref CK065K).
Pres
enta
tion
9 vials (3 sets of 3 vials) of 0.5 mL of undiluted human plasma at different concentrations of FV-L, to cover the assay range, from about 10% to 100% (4 points for the calibra-tion curve).
Ass
ay c
hara
cter
isti
cs Undiluted, freeze dried plasma set at defined concentrations of Factor V-L (10 to 50%).
Intended use : Calibration of HEMOCLOT Quanti-V-L kit (CK065K).
IVD
Biophen® Act. PC-r Control PlasmaControl Plasma Heterozygous for Factor V-L CE 510(k) #223405
Quality control plasma presenting an Activated Protein C Resistance (heterozygous), tested for Factor V-L concentration.
Pres
enta
tion
12x0.5 mL of human plasma, presenting an APC-R, citrated andlyophilized
Ass
ay c
hara
cter
isti
cs Normal human citrated plasmas, freeze dried and stabilized, titrated for various factor activities.
Concentrations are established against a reference preparation from normal donors and patients pres-enting APC resistance (FVL).
High stability following reconstitution.
Intended use : Quality control plasma for the qualitative or quantitative assay of FV-Leiden (resistant to APC), with clotting assays (e.g. HEMOCLOT Factor V-L, HEMOCLOT Quanti V-L).
IVD
Factor V-L CalibratorCalibrator set for Quantitative Factor V-LClotting Assay (diluted)
CE 510(k) #SC065K
Lyophilized, prediluted (1:20) human plasmas, at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity quantitative clotting assay on human citrated plasma, using the HEMOCLOT Quanti. V-L kit (ref CK065K).
Pres
enta
tion
12 vials (3 sets of 4 vials) of 1 ml of prediluted human plasma (1:20) at different concentrations of FV-L, ranging from about 10% to 100% (3 vials for each concentra-tion).
Ass
ay c
hara
cter
isti
cs Prediluted, freeze dried plasma set at defined concentrations of Factor V-Ln (10 to 100%).
Intended use : Calibration of HEMOCLOT Quanti-V-L kit (CK065K).
IVD
Calibrators and Controls for Factor V-L
Argatroban® Plasma CalibratorCalibrator set for Argatroban® in plasma CE #SC030K
Set of calibration plasmas for Argatroban® (also called Argatra®, Arganova®, or Novastan®), measurements, titrated and optimised using the anti-IIa clotting assay HEMOCLOT Thrombin Inhibitors (#CK002K/CK002L). Pr
esen
tati
on
20 vials (4 sets of 5 vials from 0 to 2.00 µg/ml) of 1 ml human plasma supplemented with dif-ferent concentrations of Argatroban®.
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, without or with Argatroban®, at a defined level.
High stability following reconstitution.
Intended use : Calibrating the assays of Argatroban® using clotting anti-IIa methods, especially when the HEMOCLOT Thrombin Inhibitors kit (#CK002K, CK002L) is used, with the low range protocol.
IVD
Direct Thrombin Inhibitors
49
Argatroban® Control PlasmaControl set for Argatroban® in plasma CE #SC035K
Set of control plasmas for the quality control of Argatroban® (also called Argatra®, Arganova® or Novastan®) measurements, using anti-IIa clotting assays. This kit is optimised for being used with the HEMOCLOT Thrombin Inhibitors assay (low range protocol) (#CK002K/CK002L).
Pres
enta
tion
12 vials of 1 mL of human plasma supplemented at 2 different concentrations of Argatroban®(6 vials for each concentration of about 0.65 and 1.25µg/ml)
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with Argatroban®, at a defined level.
High stability following reconstitution.
Concentrations are established against a reference preparation for Argatroban®.
Intended use : Quality control of clotting assays proposed for measuring Argatroban® concentrations in plasma (especially #CK002K, CK002L).
IVD
Plasma Hirudin StandardCalibrator set for Hirudin in plasma(Low range/High range)
CE #SC020K / #SC020L
Human plasma supplemented with Hirudin, for the calibration of HEMOCLOT Thrombin Inhibitors assay (CK002K/CK002L), low range (SC020K) or high range (SC020L).
Pres
enta
tion
#SC020K (Low range)Std 0: 3x1 mL (0 μg/mL)Std 2: 3x1 mL (2 μg/mL)
#SC020L (High range)Std 0: 3x1 mL (0 μg/mL)Std 5: 3x1 mL (5 μg/mL)
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, without or with Hirudin, at a defined level.
High stability following reconstitution.
Intended use : Quality control of Hirudin assays (HEMOCLOT Thrombin Inhibitors: CK002K/CK002L).
IVD
50
Biophen® Rivaroxaban Plasma CalibratorCalibrator set for Rivaroxaban® in plasma CE #222701
Lyophilized plasmas, at a defined Rivaroxaban concentration (3 levels of about 0 to 500 ng/ml), as measured with the Biophen® DiXaI (ref 221030), for the calibration of Rivaroxaban measurements using the chromogenic assays and especially Biophen® DiXaI (Ref 221030).
Pres
enta
tion
12 vials of 1 ml human plasma supplemented with different concen-trations of Rivaroxaban® (3 levels, 4 vials for each concentration).
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with Rivaroxa-ban, at three different concentrations.
High stability following reconstitution.
These calibrators have Rivaroxaban® concentrations accurately established against an Internal Standard for Rivaroxaban®, with concentrations exactly deter-mined using the reference HPLC method.
Intended use : Quality control titrated and optimized for anti-Xa colorimetric assays (Biophen® DiXaI: 221030).
IVD
Direct Factor Xa Inhibitors
Dabigatran Control PlasmaControl set for Dabigatran in plasma CE #224701
Lyophilized plasmas, at a defined Dabigatran concentration (2 levels of about 100 and 300 ng/ml), as measured with the HEMOCLOT Thrombin Inhibitors kit (ref CK002K/CK002L), for the quality control of Dabigatran measurement with clotting or chromogenic assays. Pr
esen
tati
on
12 vials (6 sets of 2 vials) of of 1 mL of human plasma supplemented at 2 different concentrations of dabigatran.
Ass
ay c
hara
cter
isti
cs
Normal human plasma, freeze dried, with Dabiga-tran, at two different concentrations (high and low).
High stability following reconstitution.
Dabigatran Controls are accurately determined against an Internal Reference Standard, initially validated against fresh reference preparations of dabigatran, and confirmed with a physico-chemical method (HPLC).
Intended use : Quality control titrated and optimized for anti-IIa colorimetric assays (HEMOCLOT Thrombin Inhibitors:CK002K/CK002L).
IVD
Dabigatran Plasma Calibrator Calibrator set for Dabigatran in plasma CE #222801
Lyophilized plasmas, at a defined Dabigatran concentration (3 levels from about 50 to 500 ng/ml), as measured with the HEMOCLOT Thrombin Inhibitors kit (ref CK002K/CK002L), for the calibration of Direct Thrombin Inhibitor assays (clotting or chromogenic) for Dabigatran. Pr
esen
tati
on
12 vials (4 sets of 3 vials) of 1 ml human plasma supplemented with dif-ferent concentrations of Dabigatran.
Ass
ay c
hara
cter
isti
cs
Normal human plasma, freeze dried, with Dabiga-tran, at three different concentrations.
High stability following reconstitution.
Concentrations are accurately determined against an Internal Reference Standard, initially validated against fresh reference preparations of Dabigatran, spiked into a normal human citrated plasma pool, and confirmed with a physico-chemical method (HPLC).
Intended use : Quality control titrated and optimized for anti-IIa colorimetric assays (HEMOCLOT Thrombin Inhibitors #CK002K/CK002L)
IVD
Plasma Hirudin controlControl set for Hirudin in plasma CE #SC025K
Lyophilized plasmas, at a defined Hirudin concentration (2 levels), as measured with the HEMOCLOT Thrombin Inhibitors kit (ref CK002K/CK002L), for the quality control of Hirudin clotting assays.
Pres
enta
tion
6 vials of 1 mL of human plasma supplemented at 2 different concentrations of Hirudin (3 vials of each concentration of about 1 and 2 µg/ml).
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with Hirudin, at two different concentrations (high and low).
High stability following reconstitution.
Hirudin Controls are calibrated against an Internal Standard for Hirudin, initially validated against a fresh reference preparation of Lepirudin (Refludan®).
Intended use : Quality control of Hirudin assays (HEMOCLOT Thrombin Inhibitors #CK002K/CK002L)
IVD
Biophen® Rivaroxaban Control PlasmaControl set for Rivaroxaban® in plasma CE #224501
Lyophilized plasmas, at a defined Rivaroxaban concentration (2 levels of about 100 and 300 ng/ml), as measured with the Biophen® DiXaI (ref 221030), for the quality control of Rivaroxaban measurements using the chromogenic assays.
Pres
enta
tion
12 vials of 1 mL of human plasma supplemented at 2 different concentrations of Rivaroxaban® (6 vials for each concentration).
Ass
ay c
hara
cter
isti
cs
Normal human plasma, freeze dried, with Rivaroxa-ban, at two different concentrations.
High stability following reconstitution.
These controls are calibrated against an Internal Standard for Rivaroxaban®, which concentrations have been accurately determined using the refe-rence HPLC method.
Intended use : Quality control titrated and optimized for anti-Xa colorimetric assays (Biophen® DiXaI: 221030).
IVD
51
Biophen® NormalplasmaNon Titrated Human Plasmas (Normal) CE #223602 / #223605
Non-titrated normal citrated human plasma, lyophilized. This plasma is useful at any time when a source of normal citrated human plasma is required. Coagulation factors and clotting assays are within the normal range. Pr
esen
tati
on
Normal citrated human plasma
#22360210x2 mL
#2236058x5 mL
Ass
ay c
hara
cter
isti
cs Freeze dried citrated human plasma.
High stability following reconstitution.
Intended use : Non-titrated quality control human citrated plasma for coagulation assays.Dilution plasma for the assay of Lupus Anticoagulant (LA) with usual laboratory methods.
IVD
Non Titrated Human Plasmas (Normal)
Plasma PAI-1 controlControl plasma for PAI-1 #SC011K
Human plasmas, at two different and defined levels of PAI-1, for the quality control of PAI-1 ELISA.
Pres
enta
tion
CI: 3x1 mL normal plasma,(high)
CII: 3x1 mL normal plasma, (low)
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with PAI-1, at two different concentrations (high and low).
Concentrations established against the NIBSC International Standard
Intended use : Quality control of PAI-1 assay (RK012A).
RUO
Controls for Enzyme Immuno-Assays
52
FPA controlControls for FPA #SC015K
Preparations at two different and defined levels of FPA, for the quality control of FPA ELISA.
Pres
enta
tion
CI: 3x1 mL Control high
CII: 3x1 mL Control low
Ass
ay c
hara
cter
isti
cs Freeze dried preparations containing FPA at two different concentrations (high and low).
Intended use : Quality control of FPA assay (RK016A).
RUO
UTA controlsControl Plasma for uPA, tPA and Annexin V #SC017K
Lyophilized plasmas, at defined uPA: Ag, Annexin V, and tPA (UTA) concentrations for the quality control of the Annexin V assay (RK004A), the tPA assay (RK011A) and the uPA antigenic (RK013A) assay.
Pres
enta
tion
CI: 3x1 mL normal plasma (high)
CII: 3x1 mL normal plasma(low)
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with Annexin V, tPA and uPA, at two different concen-trations (high and low).
Concentrations established against the NIBSC International Standard
Intended use : Quality control of Annexin V assay (RK004A), tPA assay (RK011A), uPA assay (RK013A).
RUO
Plasma PF4 controlControl plasma for PF4 #SC013K
Human plasmas, at two different and defined levels of PF4, for the quality control of PF4 ELISA.
Pres
enta
tion
CI: 3x0.5 mL normal plasma (high)
CII: 3x0.5 mL normal plasma (low)
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with PF4, at two different concentrations (high and low).
Concentrations established against the NIBSC International Standard
Intended use : Quality control of PF4 assay (RK006A).
RUO
Plasma TAFI controlControl plasma for TAFI #SC014K
Human plasmas, at two different and defined levels of TAFI, for the quality control of TAFI ELISA.
Pres
enta
tion
CI: 3x0.5 mL normal plasma (high)
CII: 3x0.5 mL normal plasma (low)
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with TAFI, at two different concentrations (high and low).
Concentrations established against the NIBSC International Standard
Intended use : Quality control of TAFI assay (RK008A).
RUO
Plasma Protein S controlControl Plasma for Protein S #SC050K
Human plasmas, at two different and defined levels of Protein S (free and total), for the quality control of Protein S ELISA (free or total).
Pres
enta
tion
CI: 3x0.5 mL normal plasma (high)
CII: 3x0.5 mL normal plasma (low)
Ass
ay h
arac
teri
stic
s Normal human plasma, freeze dried, with Protein S, at two different concentrations (high and low).
Concentrations established against the NIBSC Internatio-nal Standard
Intended use : Quality control of Protein S assays (RK015A or RK021A).
RUO
Positive DDimer Control PlasmaControl Plasma for DDimer, High Positive #SC101K
Human plasmas, at a defined DDimer concentration (about 2 µg/mL), as measured with commercially available methods and especially the VIDAS-DDimer (Biomérieux) and the ZYMUTEST DDimer assays, for the quality control of DDimer ELISA assay. Reactive with most of the DDimer assays.
Pres
enta
tion
6x1 mL Human PlasmaA
ssay
cha
ract
eris
tics Normal human plasma, freeze dried, with
DDimer, at a positive concentration
Intended use : Quality control of DDimer assays (RK023A).
RUO
RUOLow Positive DDimer Control PlasmaControl Plasma for DDimer, Low Positive #SC103K
Human plasmas, at a defined DDimer concentration (about 0.6 µg/mL), as measured with commercially available methods and especially the VIDAS-DDimer (Biomérieux) and the ZYMUTEST DDimer assays, for the quality control of DDimer ELISA assay. Reactive with most of the DDimer assays.
Pres
enta
tion
6x1 mL Human Plasma
Ass
ay c
hara
cter
isti
cs
Normal human plasma, freeze dried, with DDimer, at a positive concentration
Intended use : Quality control of DDimer assays (RK023A).
Negative DDimer Control PlasmaControl plasma for DDimer,Negative (normal range)
#SC102K
Human plasmas, at a defined DDimer concentration (< 0.4 µg/mL), as measured with commercially available methods and especially the VIDAS-DDimer assay, for the quality control of DDimer ELISA assay.
Pres
enta
tion
6x1 mL Human Plasma
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with DDi-mer, at a negative concentration
Intended use : Quality control of DDimer assays (RK023A).
RUO
53
Plasma PAI-1 ControlControl Plasma for PAI-1 #SC011K/E
Lyophilized plasmas, at two defined PAI-1:Ag concentrations, as measured with the ELITEST-PAI-1 : Ag kit (ref CK102A), for the quality control of ELITEST PAI-1 antigenic assays.
Pres
enta
tion
CI: 3x1 mL normal plasma, (high)
CII: 3x1 mL normal plasma, (low)
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with PAI-1, at two different concentrations (high and low).
Concentrations established against the NIBSC Inter-national Standard
Intended use : Quality control of PAI-1 assay (CK102A).
UTA controlsControl Plasma for uPA, tPA and Annexin V #SC017K/E
Lyophilized plasmas, at defined uPA: Ag, Annexin V, and tPA (UTA) concentrations for the quality control of the ELITEST tPA antigenic assay (CK101A).
Pres
enta
tion
CI: 3x1 mL normal plasma, (high)
CII: 3x1 mL normal plasma, (low)
Ass
ay c
hara
cter
isti
cs Normal human plasma, freeze dried, with Annexin V, tPA and uPA, at two different concentrations (high and low).
Concentrations established against the NIBSC Inter-national Standard
Intended use : Quality control of tPA assay (CK101A).
RUO
RUO
Controls for the ELITEST Line of Cardiovascular Assays
54
55
PART 7 : AUXILIARY REAGENTS
PAR
T 7
: A
UX
ILIA
RY
REA
GEN
TS
56
PART 7 : AUXILIARY REAGENTS
Para-Nitro-Aniline (pNA) #AR014A
Size 1x5 mL Standard pNA solution at 0.10 mmol/L
Molecular weight: 138.1 Da
Intended use : For quality control of spectrophotometers or photometers at 405 nm.
RUO
TMB substrate #AR012A
Size 1x25 mL Ready to use
Peroxidase substrate containing TMB and hydrogen peroxide, stabilized
Intended use : Colour development in ELISA techniques using peroxidase.
TMB-HS #AR027A
Size
1x25 mL High sensitivity TMB substrate.Ready to usePeroxidase substrate containing TMB and hydrogen peroxide, stabilized
Intended use : Colour development in ELISA techniques using peroxidase.
RUO
RUO
Reference Material
ELISA Substrate
Buffers for Chromogenic Assays
Tris buffer #AR008A/AR008K
Size
1x50 mL (AR008A)3x50 mL (AR008K)
Ready to usepH 8.40
Intended use : For chromogenic assays.
RUO
Tris-NaCl buffer #AR009A/AR009K
Size
1x50 mL (AR009A)3x50 mL (AR009K)
Ready to usepH 8.40
Intended use : For chromogenic assays (anti-IIa).
RUO
Tris-EDTA buffer #AR015A/AR015B
Size
1x10 mL (AR015A)1x20 mL (AR015B)
pH 8.40 ± 0.110 fold concentrated
Intended use : For chromogenic assays (anti-Xa).
RUO
57
Buffers and Solutions for Clotting Assays
Tris-BSA buffer #AR020A
Size
1x20 mL pH 7.30 ± 0.1010 fold concentrated
Intended use : Diluent for proteins.
RUO
Prothrombin Activator Diluent #AR022A
Size
1x20 mL Ready to usepH 7.90 ± 0.10Contains a fibrin polymerization inhibitor
Intended use : Specific Diluent for the chromogenic assay of Prothrombin.
RUO
Progressive AT - Tris buffer – Anti Xa #AR103A
Size
1x10 mL Ready to usepH 7.85
Intended use : Dilution buffer for Progressive Antithrombin activity assay, using a variant protocol for Biophen® Antithrombin kit (#221102/221105).
RUO
Progressive AT - Tris buffer – Anti IIa #AR104A
Size
1x10 mL Ready to usepH 8.40
Intended use : Dilution buffer for Progressive Antithrombin activity using an Anti IIa method, and a variant protocol of Biophen® AT (Anti IIa) kit (#221122), performed in the absence of Heparin.
RUO
Special Tris-BSA buffer CE #AR026A/AR026K
Size
3x25 mL(AR026A)12x25 mL(AR026K)
Ready to use pH 7.90 ± 0.10Contains 1% BSA and FVIII:C stabilizers.
Intended use : Special dilution buffer for FVIII:C or FIX(a) chromogenic assays, especially using Biophen® FVIII:C (ref 221402) or Biophen® FIX (ref 221802) or Biophen® FIXa (act FIX) (ref 221812) kit.
IVD
Calcium Chloride CE #AR001A/AR001K
Size
3x25 mL (AR001A)12x25 mL (AR001K)
Ready to useCalcium Chloride solution 0.025 M (M/40)
Intended use : Coagulation assays, such as the Activated Partial Thromboplastin Time (APTT) or for the assays of factors of the intrinsic coagulation pathway.
IVD
58
Tris-NaCl buffer (TBS) #AR004A/AR004K
Size
1x50 mL (AR004A) 3x50 mL (AR004K)
Ready to usepH 7.50 (I=0.15)
Intended use : For clotting tests.Diluent for plasma samples.
RUO
Tris-NaCl buffer (TBSA) #AR005A/AR005K
Size
1x50 mL (AR005A) 3x50 mL (AR005K)
Ready to usepH 7.40Contains 1% BSA
Intended use : Diluent for purified proteins and enzymes.
RUO
Phosphate-NaCl buffer (PBS) #AR006A/AR006K
Size
1x50 mL (AR006A) 3x50 mL (AR006K)
Ready to usepH 7.50Usual physiological Diluent
Intended use : Biological dilution buffer.Cannot be used for tests performed in presence of calcium.
RUO
Calcium Chloride CE #AR002A/AR002K
Size
1x25 mL (AR002A) 3x25 mL (AR002K)
10 fold ConcentratedCalcium Chloride solution 0.25 M (M/4)
Intended use : Coagulation assays, such as the Activated Partial Thromboplastin Time (APTT) or for the assays of factors of the intrinsic coagulation pathway.
IVD
Phosphate-NaCl buffer (PBSA) #AR007A/AR007K
Size
1x50 mL (AR007A) 3x50 mL (AR007K)
Ready to usepH 7.50Contains 1% BSA
Intended use : Cannot be used for tests performed in presence of calcium.Diluent for purified proteins and enzymes
RUO
Imidazole buffer CE #AR021A/AR021K/AR021L
Size
1x25 mL (AR021A) 3x25 mL (AR021K)12x25 mL (AR021L)
Ready to usepH 7.30
Intended use : Buffer for clotting assays (plasma samples).Diluent for plasma
IVD
59
TMB substrate Refer to page 56RUO
Buffers and solutions for ELISA
Fibrinolysis Sample Diluent #AR016A
Size
1x50 mL Ready to usepH 7.50Phosphate buffer with EDTA, BSA and Tween 20
Intended use : For fibrinolysis investigation.
RUO
Conjugate Diluent #AR017A
Size
1x25 mL Ready to usepH 7.50Phosphate buffer with Sodium Chloride, BSA and Tween 20
Intended use : For ELISA methods.
RUO
Autoimmunity Sample Diluent #AR018A
Size
1x50 mL Ready to usepH 7.50PBS with goat serum
Intended use : For testing autoantibodies by ELISA.
RUO
ELISA Dilution buffer, with albumin #AR010A
Size 1x50 mL Ready to use
Contains sodium phosphate, Sodium Chloride, Tween 20 (0.1%) and BSA (1%)
Intended use : For immuno-enzymatic assays.
RUO
FPA anticoagulant solution #AR013A
Size 1x20 mL Ready to use
Contains TriSodium citrate, Heparin, Aprotinin and Hirudin
Intended use : Blood collection for FPA testing.
RUO
Wash solution for ELISA #AR011A/AR011K
Size 1x50 mL (AR011A)
3x50 mL(AR011K)20 fold concentratedContains sodium phosphate, Sodium Chloride and Tween 20 (0.1% after dilution)
Intended use : For immuno-enzymatic assays.
60
Stop solution #AR019A
Size 1x6 mL 0.45 M sulfuric acid
Ready to use
Intended use : For ELISA methods.
RUO
Bentonite suspension #AR024A
Size 1x50 mL Ready to use
Bentonite slurry
Intended use : Removal of Fibrinogen in plasma for the assay of FPA.
RUO
B2F Sample Diluent #AR023A
Size
1x60 mL Ready to usepH 7.50Buffer containing phosphate, Sodium Chloride, Prionex® and Tween 20
Intended use : Dilution buffer for Fibrinogen, Fibronectin and β2GP1 ELISA method
RUO
Solutions for Microparticles
Wash solution for Microparticles #AR025A
Size 1x50 mL 10 fold concentrated
pH 7.50 (after 1: 10 dilution)
Intended use : For microparticle kit (ZYMUPHEN MP-Activity #521096).
RUO
PART 8 : EXPLORATION OF FIBRINOLYSIS
61
PART
8 :
FIBR
INOL
YSIS
62
PART 8EXPLORATION OF FIBRINOLYSIS
Assays for Fibrinolysis Proteins
ZYMUTEST PAI-1 ActivityPlasminogen Activator Inhibitor-1Bio-Immunoassay
#RK019A
Bio-immuno assay for the measurement of PAI-1 activity.
Assay designed with an ELISA plate coated with active tPA, then stabilized, which binds active PAI-1 present in plasma or in tested sample. This is then revealed with a specific Murine monoclonal antibody, specific for PAI-1, and labelled with Horse Radish Peroxidase (HRP).
Pres
enta
tion
12x8 test kit2x Sample Diluent3x PAI-1 activity Calibrator1x high & low Plasma PAI-1 Controls3x Anti-h-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h15Detection Threshold: ≤ 0.1 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5–10%
Specific for PAI-1 active forms, this can bind to tPA.
Intended use : Assay proposed for the measurement of PAI-1 activity in research applications.
ZYMUTEST PAI-1 AgPlasminogen Activator Inhibitor-1 Immunoassay CE #RK012A
Two-site ELISA method for the measurement of PAI-1 antigen (Plasminogen-Activator-Inhibitor 1).
Assay designed with two complementary Murine monoclonal antibodies specific for PAI-1. The assay measures homogeneously PAI-1 whether its presentation is: free, active, latent, inactive, complexed with tPA, uPA or vitronectin. Controls are included.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x PAI-1 standard1x high & low Plasma PAI-1 Controls3x Anti-h-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h15Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%
No Significant interference of: Heparin up to 2 IU/mL
Intended use : Assay of PAI-1: Ag in clinical samples.
Measurement of PAI-1 as a cardiovascular risk factor.
Assay of PAI-1 in diabetes or in metabolic disorders.
Biophen® PlasminogenPlasminogen Chromogenic Assay CE #221502
Chromogenic assay of Plasminogen tested as a Plasminogen streptokinase complex, by its specific activity on a chromogenic substrate. Insensitive to the fibrinogen concentration.
Pres
enta
tion
R1: 2x2.5 mL Activationreagent containingstreptokinase (about25,000 IU) andPlasminogen-free fibri-nogen
R2: 2x6.25 mg ofChromogenic substrate,specific for Plasmin and“Plasminogen-streptoki-nase” complexes (SPm41). A
ssay
cha
ract
eris
tics
Total Assay Time: 6 min.Detection Threshold: ≤ 10%Dynamic Range: 10-150%Intra-Assay CV: < 4%Inter-Assay CV: < 6%
No significant interference observed for heparin concentrations <2 IU/mL, Bilirubin concentrations <0.2 mg/mL, and hemoglobin concentrations <2 mg/mL in plasma.
No significant interference of plasma fibrinogen concentration in the assay.
Intended use : Assay of Plasminogen in human plasma for the diagnosis of hereditary or acquired Plasminogen deficiencies.Assay of Plasminogen in any biological fluid where it must be measured.
RUO
IVD
IVD
63
Biophen® Plasminogen (LRT)Plasminogen Chromogenic AssayLiquid technology
CE #221511
Chromogenic assay for the quantitative determination of Plasminogen Activity in human plasma, using a manual or an automated method.
Liquid Reagent Technology (LRT)
Pres
enta
tion
Ready to use reagent. R1: 3x3 mL streptokinase (10,000 IU/ml) and plasmi-nogen-free fibrinogen.
R2: 3x3 mL substrate, specific for plasmin and “plasminogen-streptoki-nase” complexes (SPm41) A
ssay
cha
ract
eris
tics
Total Assay Time: 6 min.Detection Threshold: ≤ 10%Dynamic Range: 10-150%Intra-Assay CV: < 4%Inter-Assay CV: < 6%
No significant interference observed for heparin concentrations <2 IU/mL, Bilirubin concentrations <0.2 mg/mL, and hemoglobin concentrations <2 mg/mL in plasma.
No significant interference of plasma fibrinogen concentration in the assay.
Intended use : Assay of Plasminogen in human plasma for the diagnosis of congenital or acquired Plasminogen deficiencies. An abnormal Plasminogen activity is an indicator for fibrinolytic troubles.
Biophen® a-2-APa2-Anti-Plasmin Chromogenic Assay
#220502
Quantitative assay for measuring plasmin inhibitor (a2-antiplasmin) activity in human citrated plasma.
Pres
enta
tion
R1: 3x3 mL Purified plasmin
R2: 3X3 mL Plasmin substrate
Ass
ay c
hara
cter
isti
cs Total Assay Time: 8 min. Detection Threshold: < 5%Dynamic Range: 0 to 150%Intra-Assay CV: < 4%Inter-Assay CV: < 5%
Intended use : Assay proposed for the measurement of plasmin inhibitor (a2-antiplasmin) activity in research applications.
ZYMUTEST TAFI AgThrombin Activatable FibrinolysisInhibitor Immunoassay
#RK008A
Two-site ELISA method for the measurement of TAFI antigen (Thrombin Activatable Fibrinolysis Inhibitor). Assay designed with a Murine monoclonal antibody specific for TAFI, for coating, and a goat polyclonal antibody labelled with a Horse Radish Peroxidase (HRP) marker. Assay calibrator has a defined concentration of TAFI Ag, expressed as % of normal pooled human plasma, and exactly determined with three selected human plasma pools. TAFI and TAFIa are identically measured.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Plasma TAFI Calibrator1x high & low Plasma Controls3x Anti-h-TAFI-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 3h15 Detection Threshold: ≤ 5%Dynamic Range: 5 to 100%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%
Intended use : High TAFI Ag concentrations involve a hypofibrinolytic status, which can induce an elevated risk of thrombosis.Measurement of TAFI Ag on plasma in order to diagnose a risk of a hypofibrinolysis resulting from an excess of TAFI.
IVD
RUO
RUO
ZYMUTEST proTAFI proTAFI Immunoassay #RK037A
Two-site ELISA method, designed with a pair of specific and complementary monoclonal antibodies, for measuring human TAFI zymogen (Thrombin Activatable Fibrinolysis Inhibitor), i.e. proTAFI, in plasma, or in any fluid where proTAFI can be present.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x Plasma proTAFI Cali-brator1x high & low Plasma Controls3x Anti-h-proTAFI-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 3h15Detection Threshold: ≤ 10%Dynamic Range: 10-140%Intra-Assay CV: 2-5%Inter-Assay CV: 1-6%
Intended use : Assay proposed for the measurement of proTAFI in research applications.
RUO
64
ZYMUTEST tPA Ag Immunoassay for Tissue PlasminogenActivator, Antigen
CE #RK011A
Two-site ELISA method for the measurement of tPA antigen (tissue-type Plasminogen activator). Assay designed with two complementary Murine monoclonal antibodies.
The assay measures homogeneously tPA whether its presentation is: free or complexed with its inhibitors. Controls are included.
Pres
enta
tion
12x8 test kit2x Sample Diluent4x tPA standard1x high & low Plasma Controls3x Anti-h-tPA-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%
No Significant interference of Heparin up to 2 IU/mL, endogenous PAI-1 up to 100 ng/mL.
The kit measures homogeneously tPA, whether its presentation is, free and active or complexed with its inhibitors.
Intended use : Assay of tPA:Ag in clinical samples, as a disease marker.Assay of tPA:Ag in thrombolysis with recombinant tPA drugs.Assay of tPA:Ag as a cardiovascular disease marker.
ZYMUPHEN tPA Activity Bio-Immunoassay for Tissue PlasminogenActivator, Activity
#521296
Bio-immuno assay for the measurement of tPA activity. Assay designed with an ELISA plate coated with murine monoclonal antibody specific for tPA, then stabilized, which binds tPA present in plasma or in tested sample. tPA activity is then revealed through activation of plasminogen, in presence of tPA stimulator, and consequent cleavage of a substrate specific for Plasmin.
Pres
enta
tion
All the necessary for performing a 96 well microElisa plate.
tPA is measured in acidi-fied plasma for blocking tPA inhibitors.
Ass
ay c
hara
cter
isti
csTotal Assay Time: about 2hDetection Threshold: 0.1 IU/mLDynamic Range: 0 to 2 IU/mLIntra-Assay CV: ≤ 8%Inter-Assay CV: ≤ 10%
Intended use : Assay proposed for the measurement of tPA activity in research applications.
IVD
RUO
ZYMUTEST tPA-PAI-1 complexes tPA-PAI-1 Complexes Immunoassay #RK017A
Two-site ELISA method for the measurement of tPA-PAI-1 complexes. Assay designed with a Murine monoclonal antibody specific for tPA for coating, and capturing tPA-PAI-1 complexes, and a Murine monoclonal antibody, specific for PAI-1 and labelled with a Horse Radish Peroxidase (HRP) marker. The assay only measures tPA-complexed with PAI-1.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x tPA-PAI-1 Calibrator1x high & low Plasma Controls3x Anti-h-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 2h15
Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5–10%
Intended use : Assay proposed for the measurement of tPA-PAI-1 complexes in research applications.
ZYMUTEST uPAUrokinase-TypePlasminogen Activator Immunoassay
#RK013A
Two-site ELISA method for the measurement of uPA (Urokinase-type Plasminogen activator). Assay designed with three complementary Murine monoclonal antibodies specific for uPA, are being used for coating the microplate (immunocapture), and the two others labelled with a Horse Radish Peroxidase (HRP) marker. This assay measures similarly High Molecular Weight Urokinase (HMW-PA or u-PA) or Low Molecular Weight Urokinase (UK) in plasma, whether free of complexed with its inhibitors.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x uPA standard1x high & low Plasma Controls3x Anti-h-uPA-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 1h15 Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5–10%
Measures HMW and LMW Urokinase forms in plasma.
Intended use : Assay proposed for the measurement of uPA in research applications.
RUO
RUO
65
ZYMUTEST uPA-PAI-1 complexesuPA-PAI-1 Complexes Immunoassay #RK018A
Two-site ELISA method for the measurement of uPA-PAI-1 complexes. Assay designed with a Murine monoclonal antibody specific for uPA for coating, and capturing uPA-PAI-1 complexes, and a Murine monoclonal antibody, specific for PAI-1 and labelled with a Horse Radish Peroxidase (HRP) marker. The assay only measures uPA complexed with PAI-1.
Pres
enta
tion
12x8 test kit2x Sample Diluent3x uPA-PAI-1 Calibrator1x high & low Plasma Controls3x Anti-h-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics Total Assay Time: 2h15
Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5–10%
Intended use : Assay proposed for the measurement of uPA-PAI-1 complexes in research applications.
RUO
ELITEST tPATissue Plasminogen Activator Immunoassay #CK101A
Two-site Enzyme ImmunoAssay (ELISA), designed with Murine monoclonal antibodies, for the quantitative determination of tissue-type Plasminogen Activator (t-PA) in human plasma or cell culture supernatant.
Pres
enta
tion
12x8 test kit2x Sample Diluent6x rec. t-PA standard solution1x Conjugate (mouse monocl. anti-tPA-HRP)1x Substrate Buffer (phos-phate citrate buff.)1x Conjugate Diluent2x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h30Detection Threshold: 0.5 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%No interference of Urokinase solutions up to10 µg/mLAssay highly specific for t-PA (one-chain and two-chain forms).Presence of PAI does not interfere with the t-PA quantization.Heparin in the plasma (<10 UI/mL) does not influence the determination.Reference Material: t-PA standard solutions carefully calibrated against the W.H.O. reference preparation (2nd International Standard 86/670).
Intended use : Assay proposed for the measurement of tPA antigen in research applications.
RUO
ELITEST PAI-1Plasminogen ActivatorInhibitor-1 Immunoassay
#CK102A
Two-site Enzyme ImmunoAssay (ELISA), designed with Murine monoclonal antibodies, for the quantitative determination of Plasminogen Activator Inhibitor-1 (PAI-1) in human plasma or cell culture supernatant.
Pres
enta
tion
12x8 test kit2x Sample Diluent6x rec. PAI-1 standard solution1x Conjugate (mouse monocl. anti-PAI-1-HRP)1x Substrate Buffer (phos-phate citrate buff.)1x Conjugate Diluent2x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h30Detection Threshold: ≤ 2.5 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%
Intended use : Assay proposed for the measurement of PAI-1 antigen in research applications.
RUO
ELITEST Lp(a)Lipoprotein (a) Immunoassay #CK103A
Enzyme Immunoassay (ELISA) for the quantitative determination of lipoprotein (a) Lp(a) concentrations in human plasma or serum.
A Murine monoclonal antibody is used for coating (specific for Apo (a)), and a goat anti-Lp(a) polyclonal antibody (specific for Apo (b)) for Horse Radish Peroxidase (HRP) marker. The kit contains controls at two different Lp(a) levels.
Pres
enta
tion
12x8 test kit2x Sample Diluent1x Lp(a) standard1x Control serum (Level I and II)1x Substrate Buffer (phos-phate citrate buff.)1x Conjugate Diluent2x Wash Solution1x TMB A
ssay
cha
ract
eris
tics
Total Assay Time: 3h30Detection Threshold: 1 mg/dlDynamic Range: 0 to 100 mg/dLIntra-Assay CV: 4 – 6%Inter-Assay CV: 5 – 8%Measures all the forms
Intended use : Assay proposed for the measurement of Lp(a) in research applications.
RUO
Cardiovascular (Liquid Technology)
66
PART 9 : AGGREGOMETRY REAGENTS
PART 9 : AGGREGOMETRY REAGENTS
PART
9 :
AGGR
EGOM
ETRY
RE
AGEN
TS
ADPAssay for Platelet Aggregation CE #AG001K
Investigation of platelet aggregation induced by ADP.
Pres
enta
tion
3x0.5 mLAdenosine-5’-diphos-phate (200 μM)
Ass
aych
arac
teri
stic
s Total Assay Time: 50 min.Final Test Concentration: 1-10 μM
Intended use : Investigation of congenital (e.g., Glanzmann’s thrombasthenia, Bernard-Soulier, gray platelet syndrome) or acquired thrombopathy (e.g., myelodisplasic or myeloproliferative syndrome, Waldenström’s disease, multiple myeloma, hepatic or renal failure).
Follow-up of patients treated with antiplatelet drugs such as aspirin, thienopyridines, abciximab and other NSAIDs and GPIIb/IIIa inhibitors.
EpinephrineAssay for Platelet Aggregation CE #AG002K
Investigation of platelet aggregation induced by Epinephrine.
Pres
enta
tion
3x0.5 mL L-Epinephrine (1 mM)
Ass
aych
arac
teri
stic
s Total Assay Time: 50 min.Final Test Concentration: 1-10 μM
Intended use : Investigation of congenital (e.g., Glanzmann’s thrombasthenia, storage pool disease, gray platelet syndrom) or acquired thrombopathy (e.g., myelodisplasic or myeloproliferative syndrome, Waldenström’s disease, multiple myeloma).
Follow-up of patients treated with antiplatelet drugs such as aspirin, thienopyridines, abciximab and other NSAIDs and GPIIb/IIIa inhibitors.
Arachidonic Acid Assay for Platelet Aggregation CE #AG003K
Investigation of platelet aggregation induced by Arachidonic Acid.
Pres
enta
tion
3x0.5 mL Arachidonic Acid (15 mM)
Ass
aych
arac
teri
stic
s Total Assay Time: 50 min.Final Test Concentration: 1.5 mM
Intended use : Investigation of congenital (e.g., Glanzmann’s thrombasthenia, gray platelet syndrome) or acquired thrombopathy (e.g., myelodisplasic or myeloproliferative syndrome, Waldenström’s disease, multiple myeloma).
Follow-up of patients treated with antiplatelet drugs such as aspirin, thienopyridines, abciximab and other NSAIDs and GPIIb/IIIa inhibitors.
IVD
IVD
IVD
67
68
Ristocetin Assay for Platelet Aggregation CE #AG004K
Measurement of the von Willebrand Factor Ristocetin cofactor by platelet aggregation.
Pres
enta
tion
3x0.5 mL Ristocetin (15 mg/mL)
Ass
aych
arac
teri
stic
s Total Assay Time: 50 min.Final Test Concentration: 0.5 - 1.5 mg/mL
Intended use : The Ristocetin reagent is proposed for platelet aggregation tests, as an aid for the detection of von Willebrand disease, von Willebrand factor (vWF) determination, and identification of Bernard-Soulier Syndrome.
Collagen Assay for Platelet Aggregation CE #AG005K
Investigation of platelet aggregation induced by Collagen.
Pres
enta
tion
R1: 3x0.5 mL Collagen (1 mg/mL)
R2: 9x4 mL diluent Ass
aych
arac
teri
stic
s Total Assay Time: 50 min.Final Test Concentration: 2 - 10 µg/mL
Intended use : Investigation of congenital (e.g., Glanzmann’s thrombasthenia, gray platelet syndrome, storage pool disease) or acquired thrombopathy (e.g., myelodisplasic or myeloproliferative syndrome, Waldenström’s disease, multiple myeloma).
Follow-up of patients treated with antiplatelet drugs such as aspirin, thienopyridines, abciximab and other NSAIDs and GPIIb/IIIa inhibitors.
Lyophilized platelets Assay For Platelet Aggregation CE #AG006A / #AG006K
Quantitative determination of von Willebrand Factor (vWF) in human plasma, through its Ristocetin cofactor activity, by using lyophilized platelets and ristocetin.
Pres
enta
tion
R1: Formalin-fixed pla-telets, lyophilized in the presence of stabilizersR2: Tris Buffer Saline (TBS) for Lyophilized platelet reconstitution (Contains BND as stabilizer).
#AG006A1x5 mL: R1
#AG006K3x5 mL: R13x5 mL: R2
Ass
aych
arac
teri
stic
s
Total Assay Time: <10 min.To be used along with Ristocetin
Intended use : Measurement of Ristocetin cofactor activity of vWF.
IVD
IVD
IVD
69
PART 10 : RESEARCH KITS
PART
10 :
RESE
ARCH
KIT
S
PART
9: R
ESEA
RCH
70
ZYMUTEST HS-CRP (High Sensitivity) Immunoassay for C-Reactive Protein, with High Sensitivity #RK010A
Two-site ELISA method for the measurement of C-Reactive Protein (low concentrations) with a high sensitivity assay designed with goat polyclonal antibodies for coating the MicroELISA plate (immunocapture), as well as preparing the Horse Radish Peroxidase (HRP) immunoconjugate. Pr
esen
tati
on
12x8 test kit2x Sample Diluent3x Plasma CRP Calibrator1x high & low CRP controls3x Anti-h-CRP-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 1h15Detection Threshold: 1 ng/mLDynamic Range: 0 to 10 µg/mL
(0 to 100 ng/mL in the tested dilution)Intra-Assay CV: < 5%Inter-Assay CV: < 7%
Referenced to the NIBSC International StandardNo interference of Rheumatoid Factor.
No Prozone effect observed for CRP concentrations up to 100µg/mL.
Intended use : Assay proposed for the measurement of C-Reactive Protein in research applications.
RUO
High Sensitivity CRP (C-Reactive Protein)
PART 10 : RESEARCH KITS
ZYMUTEST Tissue Factor (full length) Tissue Factor Immunoassay #RK035A
Two-site ELISA method for the measurement of full length Tissue Factor (TF, full length) in human plasma or purified milieu.
The kit uses a biotin-streptavidin-HRP system to enhance greatly the sensitivity, thus permitting to detect TF concentration as low as 50 pg/mL. Pr
esen
tati
on
12x8 test kit2x Sample Diluent3x TF Calibrator1x high & low TF Controls1x Anti-h-TF biotinylated MoAb3x Streptavidin-HRP Conjugate1x Conjugate Diluent1x Wash Solution1x TMB-HS1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 4h35Detection Threshold: < 20 pg/mLDynamic Range: 0 to 500 pg/mLIntra-Assay CV: < 8%Inter-Assay CV: < 10%
Intended use : Assay proposed for the measurement of full length Tissue Factor in research application
RUO
Tissue Factor
Thrombosis and Vascular Diseases
71
ZYMUTEST TOTAL TISSUE FACTOR Total Tissue Factor Immunoassay #RK042A
Two-site, enhanced, immuno-assay for measuring human total Tissue Factor (TF), in plasma and purified milieu, or in any biological fluid where TF can be present.
Pres
enta
tion
12x8 test kit2x TF Sample Diluent3x TF Calibrator1x high & low TF Controls1x Anti-h-TF biotinylated PoAb3x Streptavidin-HRP Conjugate1x TF Conjugate Diluent1x Wash Solution1x TMB-HS1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 5h00Detection Threshold: < 10 pg/mLDynamic Range: 10 to 600 pg/mLIntra-Assay CV: < 6%Inter-Assay CV: < 10%
Intended use : Assay proposed for the measurement of Total Tissue Factor in research application
RUO
ZYMUTEST PF4 (Platelet Factor 4) Platelet Factor 4 Immunoassay #RK006A
Two-site ELISA method for the measurement of human PF4 (platelet factor 4), on platelet poor human plasma, or any biological sample where PF4 must be measured. Assay designed with affinity purified rabbit polyclonal antibodies for coating the MicroELISA plate (immunocapture) as well as preparing the Horse Radish Peroxidase (HRP) immunoconjugate marker. This assay measures native or recombinant PF4. It is insensitive to the presence of heparin in the tested sample, and PF4 is measured homogeneously whether its presentation is. The assay calibrator is standardized with the NIBSC International Standard.
Pres
enta
tion
12x8 test kit2x PF4 Sample Diluent3x PF4 Standard1x high & low PF4 Controls3x Anti-h-PF4-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Detection Threshold: < 0.1 ng/mLDynamic Range: 0.1 to 10 ng/mLIntra-Assay CV: 1-5%Inter-Assay CV: 2-7%
Reference Material established against NIBSC International Standard
Intended use : Assay proposed for the measurement of Platelet Factor 4 in research application
RUO
Platelet Markers
72
Other Hemostasis Proteins
ZYMUTEST Annexin V Annexin V Immunoassay #RK004A
Two-site ELISA method for the measurement of human annexin V. Assay designed with affinity purified rabbit polyclonal antibodies for coating the MicroELISA plate (immunocapture), as well as preparing the Horse Radish Peroxidase (HRP) immunoconjugate marker. This assay measures native or recombinant annexin V.
In addition to annexin V measurements in plasma, this assay is very useful for the quality control of platelet and blood cell concentrates (annexin V released correlates with platelet and blood cell surface lesion).
Pres
enta
tion
12x8 test kit2x Sample Diluent3x h Annexin V (rec) standard1x high & low Plasma Controls3x Anti-h-Annexin V-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h15Detection Threshold: 0.1 ng/mLDynamic Range: 0.1 to 120 ng/mLIntra-Assay CV: 1-5%Inter-Assay CV: 2.5-8%No interference of rheumatoid factor.
Intended use : Assay proposed for the measurement of Annexin V in research applications.
ZYMUTEST β2GP1 Beta2 GlycoProtein I Immunoassay #RK022A
Two site ELISA method for the measurement of b2GP1 on plasma or any biological sample where it must be measured. Assay designed with polyclonal antibodies specific for b2GP1, for coating the microplate (immunocapture) and also labelled with a Horse Radish Peroxidase (HRP) marker. This assay measures homogeneously b2GP1 in plasma.
Pres
enta
tion
12x8 test kit2x B2F Sample Diluent3x b2GPCalibrator1x high & low (h) β2GP1 Controls3x Anti-h-b2GP1-HRP IC1x B2F Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h15Detection Threshold: ≤ 5 ng/mlDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 3 - 8%Inter-Assay CV: 5 - 10%
Reference material : Calibrator established againsta normal citrated plasma pool, and against highly purified human b2GP1, which protein concentration has been precisely determined by Lowry method.
Intended use : Assay proposed for the measurement of b2GP1 antigen in research applications.
RUO
RUO
Assays for the Other Plasma Factors
LIAPHEN Fibrinogen Fibrinogen Latex Immunoassay CE #120102
Latex immunoassay for measuring Fibrinogen in human citrated plasma or in purified milieu (cell culture supernatant), using a manual or automated method, in vitro exclusively.
Pres
enta
tion
4x5 mL Latex reagent4x25 tests
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 20 min.Detection Threshold: 1 µg/mLDynamic Range: 0-10 µg/mLIntra-Assay CV: < 4%Inter-Assay CV: < 8%
No hook effect is observed for Fibrinogen concentra-tions < 100µg/mL
No interference is observed for Unfractionated Heparin concentrations < 2 IU/ml in plasma.
The presence of rheumatoid factor may result in an overestimation of the Fibrinogen concentration.
Intended use : Assay of Fibrinogen in human citrated plasma or in cell culture supernatants.
IVD
73
ZYMUTEST Fibrinogen Fibrinogen Immunoassay #RK024A
Two-site ELISA method for the measurement of Fibrinogen. Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.
Useful for testing low fibrinogen concentrations in culture media or cell exsudates, and for various research applications.
Pres
enta
tion
12x8 test kit2x B2F Sample Diluent3x Fibrinogen Standard1x high & low Fibrinogen Controls3x Anti-h-Fibrinogen-HRP IC1x B2F Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A
ssay
cha
ract
eris
tics
Total Assay Time: 2h15Detection Threshold: 1 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 – 6%Inter-Assay CV: 5 – 8%
Specimen dilution must be adjusted to the expected concentration.
Reactive with rat and mouse Fibrinogen.
Intended use : Assay proposed for the measurement of Fibrinogen in research applications.
ZYMUTEST Fibronectin Fibronectin Immunoassay #RK028A
Two-site ELISA method for the measurement of Fibronectin. Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.
Useful for testing low Fibronectin concentrations in culture media or cell exsudates, and for various research applications.
Pres
enta
tion
12x8 test kit2x B2F Sample Diluent3x Fibronectin Calibrator1x high & low Fibronectin Controls3x Anti-h-Fibronectin-HRP IC1x B2F Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
csTotal Assay Time: 1h15Detection Threshold: 1 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 – 6%Inter-Assay CV: 5 – 8%
Specimen dilution must be adjusted to the expected concentration.
Intended use : Assay proposed for the measurement of Fibronectin in research applications.
RUO
RUO
74
BIOCHEMICALS
Substrates for Thrombin
Biophen® CS-01(38) Thrombin Chromogenic Substrate #229001 / #229001C
Size
1x25 mg (229001)12x25 mg (229001C)
Peptide sequence: H-D-Phe-Pip-Arg-pNa, 2HClChemical structure: C27H36N8O5, 2HClMolarity: 45 µMolesPurity grade: > 95%.Molecular weight (-2HCl): 552.6 DaMolecular weight (+2HCl): 625.6 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30
Intended use : Chromogenic substrate for Thrombin.
RUO
Biophen® CS-01(81) Thrombin Chromogenic Substrate #229005
Size
1x25 mg Peptide sequence: Tos-Gly-Pro-Arg-pNa. AcOHChemical structure: C26H34N8O5, AcOHMolarity: about 37.75 µMolesPurity grade: > 95%.Molecular weight: 662.6 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30
Intended use : Chromogenic substrate for Thrombin.
RUO
Substrates for Factor Xa
Biophen® CS-11(32) FXa Chromogenic Substrate #229011
Size
1x25 mg Peptide sequence: Suc-Ile-Glu (g Pip)Gly-Arg-pNa, HClChemical structure: C34H52N10O10, HClMolarity: about 33 µMolesPurity grade: > 95%Molecular weight: 760.9 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30
Intended use : Chromogenic substrate for Factor Xa.
RUO
Biophen® CS-11(65) FXa Chromogenic Substrate #229014 / #229014C
Size
1x25 mg (#229014)12x25 mg (#229014C)
Peptide sequence: -D-Arg-Gly-Arg-pNA, 2HClChemical structure: C28H39N11O7, 2HClMolarity: about 39.0 µmol/vialPurity grade: > 95%Molecular weight (-2 HCl): 641.7 DaMolecular weight (+2 HCl): 714.7 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30
Intended use : Chromogenic substrate for Factor Xa.
RUO
Chromogenic Substrates
75
Substrate for Activated Protein C
Biophen® CS-21(66) Activated Protein C Chromogenic Substrate #229021
Size
1x25 mg Peptide sequence: p-Glu-Pro-Arg-pNa. HClChemical structure: C22H30N6O6, HClMolarity: about 50 µmol/vialPurity grade: > 95%.Molecular weight: 502.5 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30
Intended use : Chromogenic substrate for Activated Protein C.
RUO
Biophen® CS-11(22) FXa Chromogenic Substrate #229015
Size
1x25 mg Peptide sequence: Mixture (50%-50%) of Bz-Ile-Glu (gOCH3)-Gly-Arg-pNa (form 1) and Bz-Ile- Glu (gOH)Gly-Arg-pNa (form 2)Chemical Structure: C33H45N9O9, HClMolecular weight: 711.8 Da (form 1) and 697.7 Da (form 2)Molarity: about 35 µmol/vialPurity grade: > 95%.Free pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30
Intended use : Chromogenic substrate for Factor Xa.
RUO
Substrate for Kallikrein
Substrate for Plasmin and Plasminogen–SK
Biophen® CS-31(02)Kallikrein Chromogenic Substrate #229031
Size
1x25 mg Peptide sequence: D-Pro-Phe-Arg-pNa, 2HClChemical structure: C26H34N8O5, 2HClMolarity: about 46 µmol/vialPurity grade: > 95%Molecular weight: 538.6 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30
Intended use : Chromogenic substrate for Kallikrein.
RUO
Biophen® CS-41(03)Plasmin and Plasminogen-SK Chromogenic Substrate #229041
Size
1x25 mg Peptide sequence: PyroGlu-Phe-Lys-pNa, HClChemical structure: C26H32N6O6, HClMolarity: about 48 µmol/vialPurity grade: > 95%Molecular weight: 524.6 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30.
Intended use : Chromogenic substrate for Plasmin and Plasminogen – SK.
RUO
76
Substrate for Factor IXa
Biophen® CS-51(09)FIXa Chromogenic Substrate #229051
Size
1x25 mg Peptide sequence: CH3SO2-(D-)CHG-Gly-Arg-pNa, AcOHChemical structure: C23H36N8O7S, AcOHMolarity: about 40 µmol/vialPurity grade: > 95%Molecular weight: 628.7 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30
Intended use : Chromogenic substrate for Factor IXa.
RUO
Substrate for UrokinaseBiophen® CS-61(44)Urokinase Chromogenic Substrate #229061
Size
1x25 mg Peptide sequence: pyro-Glu-Gly-Arg-pNa.HClChemical structure: C19H26N8O6, HClMolarity: about 54 µmol/vialPurity grade: > 95%Molecular weight: 462.5 DaFree pNA content (measured on substrate at 2.5g/L) : OD405nm ≤ 0.30.
Intended use : Chromogenic substrate for Urokinase.
RUO
Biophen® CS-05(88) tPA and Broad Spectrum Chromogenic Substrate #229091
Size
Chromogenic substrate for tPA.
Peptide sequence: H-D-Ile-Pro-Arg-pNa-2HClMolarity: about 49.5 µmol/vialPurity grade: > 95%Molecular weight: 504.6 DaFree pNA content (measured on substrate at 2.5g/L) OD405nm ≤ 0.30
Intended use : Chromogenic substrate for tPA.
RUO
Fluorogenic Substrates
Fluorogenic Substrate for Factor Xa
FLUOPHEN® FXaFXa Fluorogenic Substrate #329011
Size
1x25 mg Peptide sequence: Suc-Ile-Gly (g Pip)Gly-Arg-AMCPurity grade: > 95%Molecular weight: 798 DaFree pNA content: < 0.05%.
Intended use : Synthetic Fluorogenic substrate for testing Factor Xa.
RUO
Broad Spectrum Substrate for tPA
77
TABLE OF PROTEINS INVOLVED IN HEMOSTASIS AND FIBRINOLYSIS
Factor MWkDa
PlasmaConcentration Synthesis Half-Life
in vivo
Factor XII 80 30 µg/mL Liver 2-3 day(s)
Factor XI 160Homodimer 3-7 µg/mL Liver 2-3 day(s)
HMW Kininogen 85 30-50 µg/mL Liver 5-6 day(s)
Prekallikrein 120 60-80 µg/mL Liver 1-2 day(s)
Factor II or Prothrombin 72 100 µg/mL Liver 1-2 day(s)
Factor VII 50 0.3-0.5 µg/mL Liver 4-6 Hours(s)
Factor IX 55 4-5 µg/mL Liver 24 Hours(s)
Factor X 58 8-12 µg/mL Liver 1-2 day(s)
Protein C 62 4-5 µg/mL Liver 4-6 Hours(s)
Protein S 69 10 µg/mL (free)25 µg/mL (total) Liver 1-2 day(s)
Protein Z 62 2-4 µg/mL Liver 2-3 day(s)
AT III 58 150 µg/mL Liver 2-3 day(s)
a2- Macroglobuline 725 2-5 mg/mL LiverEndothelial cells 2-3 day(s)
Heparin Co-II 66 90 µg/mL Liver 2-3 day(s)
Protein C inhib. (PAI-3) 57 5 µg/mL Liver 1 day
TFPI 33 8-15 ng/mL (free)60-100 ng/mL (total) Endothelial cells -
(short)
Protein Z inhib. (ZPI) 72 3-7 µg/mL Liver 2-3 day(s)
Factor V 330 10 µg/mL LiverMegacaryocytes 12 Hours(s)
Factor VIII:C 265 0.1 µg/mL Liver 12 Hours(s)
Thrombomodulin 60 Expressed on Endothelial cells Endothelial cells -
C1-INH 106 180 µg/mL Liver 1-2 day(s)
Plasminogen 90 200 µg/mL Liver 2-3 day(s)
HRGP 67 100 µg/mL Liver 3 day(s)
a2-AP 70 70 µg/mL Hepatocytes 60 Hours(s)
tPA 68 < 10 ng/mL Endothelial cells 5 min
uPA 55 < 5 ng/mL Kidney 8 min
PAI-1 50 < 30 ng/mL Endothelial cells, Liver, Megacaryocytes 5 min
PAI-2 47 < 10 ng/mL Placenta, Leukocytes, Macrophages 120 min
TAFI 60 2.5 µg/mL Liver -
C4b-BP 590 250 µg/mL - 2-3 day(s)
vWF 500-2000(sub-units of 260) 8-12 µg/mL Endothelial cells,
Megacaryocytes 12 Hours(s)
Tissue Factor 45 Extra vascular Many non vascular cellsMonocytes, Endothelial cells
-(short)
Fibrinogen 340 2-4 mg/mL Liver 2-3 day(s)
b2GP1 50 200 µg/mL Liver -
Factor XIII 320 (A2B2 Complex) 10-15 µg/mL Liver 3-4 day(s)
Cont
act P
hase
Inhi
bito
rsO
ther
sFi
brin
olys
isCo
fact
ors
Vita
min
K d
epen
dent
Pr
otei
ns
78
Hemostasis and Fibrinolysis Human Proteins
Antithrombin III Molecular Weight: 58,000 Da
Intended use : Recommended for any study on heparin and glyco-amino-glycans. Useful for designing heparin assays (clotting or chromogenic) where a source of ATIII is required.
Specifications :
Preserved structure and activity of the native protein
Stability of reconstituted product > 15 days
Specific activity > 6 U/mg
Plasma Equivalent Unit (amount in 1 mL of human normal plasma) noted PEU or U, corresponds to about 150 µg of AT III Grade 1 > 60 PEU
150 µg (1mL-1 PEU) #PP004A6x150 µg (6x1 mL) #PP004K
1.5 mg (1mL-10 PEU) #PP004B10x1.5 mg (10x1 mL) #PP004L
3.75 mg (1mL-25 PEU) #PP004D10x3.75 mg (10x1 mL) #PP004M10 mg (2 mL > 60 PEU) #PP004C
Presence of sodium phosphate and sodium chloride (can be used for covalent coupling)
RUO
β2GP1 Molecular Weight: 50,000 Da
Intended use : Recommended for use as a protein cofactor for the binding of anti-b2GP1 auto antibodies in the presence or the absence of anionic Phospholipids.
Specifications :
High purity grade protein, purified with non-denaturing procedures, which keep the structure and the Phospholipid binding capacity of the native protein
100 µg (1 mL) ≈20 PEU #PP010A
For testing Phospholipid dependent antibodies, see also Prothrombin (PP006B), Protein S (PP012A), Annexin V (RP004A), Protein C (PP009A) and Protein Z (PP011A).
RUO
C4b-BP Molecular Weight: 590,000 Da
Intended use : Research studies and protocols where a source of highly purified C4b-BP is required.
Specifications :
Highly purified human protein, fully active for the binding to Protein S
100 µg (1 mL ≈ 0.5 PEU) #PP015A
RUO
Fibrinogen Molecular Weight: 340,000 Da
Intended use : Source of highly purified human fibrinogen for laboratory studies.
Specifications :
Full preservation of the native protein structure and activity.
Coagulability > 98%.
Stability of reconstituted product > 48 hrs.
Contains TriSodium citrate, sodium chloride and barbital.
5 mg (1 mL) #PP001A6x5 mg (6x1 mL) #PP001K100 mg (10 mL) #PP001B
1 g (50 mL) #PP001C100 mg #PP001R
Presence of sodium phosphate and sodium chloride (can be used for covalent coupling)
RUO
BIOLOGICALSHuman Proteins
79
Fibrinogen fragment DMolecular Weight:
80,000 – 100, 000 Da
Intended use : Research studies.
Specifications :
Plasmin cleaved Fragment D during fibrinogen degradation 200 µg (1 mL) #PP016A
RUO
Fibrinogen fragment E Molecular Weight: 50,000 Da
Intended use : Research studies.
Specifications :
Plasmin cleaved fragment E from fibrinogen 200 µg (1 mL) #PP018A
RUO
Fibrinogen fragment E3t Molecular Weight: 45,000 Da
Intended use : Research studies.
Specifications :
Terminal fragment E generated upon extensive degradation of fibrinogen by Plasmin 200 µg (1 mL) #PP019A
RUO
Fibrinogen fragment DDMolecular Weight:
160,000 – 200, 000 Da
Intended use : Research studies.
Specifications :
Fragment DD is the latest degradation product from the fibrin degradation by fibrinolysis 200 µg (1 mL) #PP017A
RUO
Fibrinogen, Plasminogen free Molecular Weight: 340,000 Da
Intended use : Source of highly purified human fibrinogen for laboratory studies.
Specifications :
Full preservation of the native protein structure and activity.Plasminogen is specifically depleted by affinity chromatographyCoagulability > 98%.Stability of reconstituted product > 48 hrs.Contains TriSodium citrate, sodium chloride and barbital.
5 mg (1 mL) #PP002A6x5 mg (6x1 mL) #PP002K100 mg (10 mL) #PP002B
1 g (50 mL) #PP002C
RUO
80
Fibrin fragment E Molecular Weight: 50,000 Da
Intended use : Research studies.
Specifications :
Fibrin fragment E is released during fibrin degradation by fibrinolysis. FPA and FPB are missing 200 µg (1 mL) #PP020A
RUO
Prekallikrein pool
Intended use : Substrate for Prekallikrein activation. Generates Kallikrein activity when activated.
Specifications :
Semi purified source of plasma Prekallikrein for the assay of Prekallikrein activators
2 mL #PP501B6x2 mL #PP501K
RUO
tPA Stimulator
Intended use : Protocols or research studies where a source of tPA stimulator is required.
Specifications :
Tissue Plasminogen Activator (tPA) stimulator, obtained from oxidized Fibrin(ogen) fragments.
1 mg (2 mL) #PP021B6x1 mg #PP021K
RUO
Heparin Cofactor II Molecular Weight: 66,000 Da
Intended use : Heparin studies.
Specifications :
Highly purified human protein, fully activeThe unit PEU or (U) represents the biological activity in 1 mL of normal plasma.
100 µg (1 mL = 1 PEU) #PP014A
1 mg (1 mL = 10 PEU) #PP014C
RUO
Plasminogen Molecular Weight: 88,000 Da
Intended use : Recommended for any study on fibrinolysis.
Specifications :
Homogeneous and non-activatedSpecific activity > 4 U/mg
Lyophilized in presence of sodium phosphate and sodium chloride (can be used for covalent coupling)
200 µg (1 mL) #PP005A
1.5 mg (2 mL) #PP005B
5 mg (0.5 mL) #PP005C
RUO
81
Alpha 1 Acid GlycoProtein (AGP) Molecular Weight: ≈ 40,000 Da
Intended use : For laboratory studies.
Specifications :
Highly purified AGP preparation 100 µg (1mL) #PP201A
RUO
Prothrombin Molecular Weight: 72,000 Da
Intended use : Research and Laboratory technology applications.
Specifications :
Specific activity ≥ 8 U/mgThe unit PEU or (U) represents the biological activity in 1 mL of normal plasma.
1 mg (1 mL) ≈10 PEU #PP006B
6x1 mg (6x1 mL) ≈10 PEU #PP006K
RUO
Factor VII Molecular Weight: 55,000 Da
Intended use : Research and Laboratory technology applications.
Specifications :
Specific activity ≥ 2,000 U/mg 100 µg (1 mL) #PP013A
RUO
Miscellaneous
Factor IX Molecular Weight: 55,000 Da
Intended use : Research and Laboratory technology applications.
Specifications :
Specific activity ≥ 160 U/mg
The unit PEU or (U) represents the biological activity in 1 mL of normal plasma.
100 µg (1 mL) ≈ 20 PEU #PP007A
RUO
Factor X Molecular Weight: 59,000 Da
Intended use : Research and Laboratory technology applications.
Specifications :
Specific activity ≥ 80 U/mg
The unit PEU or (U) represents the biological activity in 1 mL of normal plasma.
100 µg (1 mL) ≈ 10 PEU #PP008A
RUO
Vitamin K Dependent Proteins
82
Platelet factor 4 (PF4) Molecular Weight: 30,000 Da
Intended use : High purity preparation, in the tetrameric form, tested for its anti-heparin activity. In presence of heparin, this product offers an optimized binding capacity for heparin dependent antibodies developed in HIT (Heparin Induced Thrombocytopenia).
Specifications :
Specific activity ≥ 250 U/mg 100 µg (1 mL) #PP003A
RUO
Protein C Molecular Weight: 62,000 Da
Intended use : Research and Laboratory technology applications.
Specifications :
Specific activity ≥ 200 U/mgThe unit PEU or (U) represents the biological activity in 1 mL of normal plasma.
100 µg (1 mL) ≈ 20 PEU #PP009A
RUO
Protein S Molecular Weight: 75,000 Da
Intended use : Research and Laboratory technology applications.
Specifications :
Specific activity ≥ 75 U/mgThe unit PEU or (U) represents the biological activity in 1 mL of normal plasma.
100 µg (1 mL) ≈ 10 PEU #PP012A
RUO
Protein Z Molecular Weight: 62,000 Da
Intended use : Research and Laboratory technology applications.
Specifications :
Specific activity ≥250 U/mgThe unit PEU or (U) represents the biological activity in 1 mL of normal plasma.
100 µg (1 mL) ≈ 25 PEU #PP011A
RUO
Platelet Proteins
83
Recombinant Human Proteins
Annexin V (recombinant, human) Molecular Weight: 36,000 Da
Intended use : Research studies.
Specifications :
Expressed in E. Coli 100 µg (1 mL) #RP004A
RUO
PAI-1 (recombinant, human) Molecular Weight: 52,000 Da
Intended use : Research studies.
Specifications :
Stable mutant (slightly mutated structure in order to offer increased stability) 10 µg (1 mL) #RP005A
RUO
PAI-1 (recombinant, human) Molecular Weight: 52,000 Da
Intended use : Research studies.
Specifications :
Native form 10 µg (1 mL) #RP006A
RUO
tPA (recombinant, human) Molecular Weight: 72,000 Da
Intended use : Research studies.
Specifications :
Recombinant human tPA (wild type) 10 µg (1 mL) #RP007A1 mg (1 mL) #RP007C
RUO
84
Human Enzymes
Human Factor IXa Molecular Weight: 45,000 Da
Intended use : Source of Factor IXa (activated Factor IX) for research studies.
Specifications :
Activated Factor IX prepared from the highly purified Fac-tor IX through solid phase activation with Factor XIa. 100 IU #EZ010B
RUO
Human Factor XIIa Molecular Weight: 80,000 Da
Intended use : Research studies or protocols where a source of highly purified human Factor XIIa is required.
Specifications :
Factor XIIa (prekallikrein activator) highly purified from human plasma (human FactorXII activated using dextran sulphate,removed after activation). 100 ng is about 0.80 IU.
100 ng (1 mL) #EZ012A
6x100 ng (6x1 mL) #EZ012K
RUO
Human Factor Xa Molecular Weight: 46,000 Da
Intended use : Recommended for studies on heparin, glyco-amino-glycans and related products, using anti-Xa assays.
Specifications :
Prepared by activation of highly purified (h)-FX with RVV coupled to agarose beads
Stability after reconstitution > 3 months
10 µg (1 mL) #EZ007A 6x10 µg (6x1 mL) #EZ007K
100 µg (1 mL) #EZ007B6x100 µg (6x1 mL) #EZ007L
500 µg (5 mL) #EZ007C
RUO
Activated Protein C Molecular Weight: 60,500 Da
Intended use : Recommended for studies concerning the Protein C-Protein S-Thrombomodulin pathway, and for the Activated Protein C Resistance assay, or any research protocols on factors Va and VIIIa.
Specifications :
Activated with (h)-thrombin (in the a form) covalently coupled to agarose beadsStability after reconstitution > 48hrs
2.5 µg (1 mL) #EZ004A10 µg (1 mL) #EZ004B
100 µg (1 mL) #EZ004C
RUO
Human Thrombin Molecular Weight: 35,000 Da
Intended use : Recommended for all the research protocols where a source of highly purified and characterized (h)-thrombin is necessary, and for studies on anti-thrombin activities.
Specifications :
Mainly in the a formPrepared by activation of highly purified Prothrombin, in presence of factor Xa, V and calcium, then specifically purified and stabilizedStability after reconstitution > 7 days
10 NIH (1 mL) #EZ006O6x10 NIH (6x1 mL) #EZ006K
100 NIH (1 mL) #EZ006A10x100 NIH (10x1 mL) #EZ006L
1000 NIH (2 mL) #EZ006B
RUO
85
Human Plasmin Molecular Weight: 83,000 Da
Intended use : Recommended for all research protocols where a source of human plasmin is required.
Specifications :
Obtained through solid phase activation with urokinase. 0.2 mg (1 mL) #EZ013A2.0 mg (1 mL) #EZ013B
RUO
uPA (Urokinase-type Plasminogen Activator) Molecular Weight: 50,000 Da
Intended use : Recommended for all the research protocols where a source of purified urokinase is required.Can be used for the assay of human plasminogen.Activates plasminogen to generate plasmin.
Specifications :
High molecular weight Urokinase 1,000 units (1 mL) #EZ005A10,000 units (1 mL) #EZ005B
100,000 units (2 mL) #EZ005C
RUO
86
Plasminogen, Bovine Molecular Weight: 88,000 Da
Intended use : Research and laboratory technology application.
Specifications :
Specific activity > 4 U/mgPresence of sodium phosphate and sodium chloride (can be used for covalent coupling)
5 mg (5 mL) #BP105C
RUO
Fibrinogen, Bovine Molecular Weight: 330,000 Da
Intended use : Research and laboratory technology application.
Specifications :
Coagulability > 98%.Very stable following reconstitution (>48 hrs)
10 mg (1 mL) #BP101O6x10 mg (6x1mL) #BP101K
100 mg (5 mL) #BP101A1 g (50 mL) #BP101B
RUO
Bovine Proteins
Antithrombin III, Bovine (grade 1) Molecular Weight: 60,000 Da
Intended use : Heparin binding studies. Research protocols
Specifications :
Specific activity ≥ 6 U/mgPresence of sodium phosphate and sodium chloride (can be used for covalent coupling)
10 mg (2 mL) #BP104C
RUO
Prothrombin, Bovine Molecular Weight: 72,000 Da
Intended use : Research and laboratory technology application
Specifications :
Specific activity ≥ 8 U/mg 1 mg (1 mL) #BP103A6x1 mg (6x1mL) #BP103K
RUO
Factor X, Bovine Molecular Weight: 56,000 Da
Intended use : Heparin binding studies. Research protocols
Specifications :
Specific activity ≥ 80 U/mg 100 µg (1 mL) #BP102A6x100 µg (6x1mL) #BP102K
RUO
87
Bovine Enzymes
Factor Xa, Bovine Molecular Weight: 45,300 Da
Intended use : Recommended for studies on heparin, glyco-amino-glycans and related products, using anti-Xa assays
Specifications :
Prepared by activation of highly purified bovine factor X with RVV coupled to agarose beads
Stability after reconstitution > 3 months
1 µg corresponds to about 2.25 nkats using the Factor Xa chromogenic substrate BIOPHEN® CS-11(32)
15 µg (1 mL) #BE101C30 µg (2 mL) #BE101D
10x30 µg (10x2 mL) #BE101L50 µg (1 mL) #BE101O
6x50 µg (6x1 mL) #BE101K500 µg (2 mL) #BE101B
RUO
Thrombin, Bovine Molecular Weight: 35,000 Da
Intended use : Recommended for all the research protocols where a source of highly purified and characterized thrombin is ne-cessary, and studies on anti-thrombin activities.
Specifications :
Mainly in the a formPrepared by activation of highly purified Prothrombin, in presence of factor Xa, V and calcium, then specifically purified and stabilized.Stability after reconstitution > 7 days1 NIH corresponds to about 2.5 nkats using the thrombin chromogenic substrate BIOPHEN® CS-01(38)
21 NIH (1 mL) #BE102A
6x21 NIH (6x1 mL) #BE102K
100 NIH (1 mL) #BE102B
1000 NIH (2 mL) #BE102C
RUO
Thrombin, Bovine Molecular Weight: 35,000 Da
Intended use : Useful for measuring Fibrinogen with the clotting method. Fibriphen reagent (CK571K/CK572K/CK575K) is also available.
Specifications :
Optimized thrombin concentration for the classic Clauss
method
500 NIH (5 mL) #BE501C10x500 NIH (10x5 mL) #BE501K
RUO
88
Other Proteins & Enzymes
Protac® Molecular Weight: 40,000 Da
Intended use : Activates Protein C.
Specifications :
Protein C Activating Enzyme extracted from Akgistrodon Contortrix snake venom. 1 unit is the amount which activates totally Protein C present in 1 mL normal human plasma
1 unit #EZ011A
5 units #EZ011B
RUO
Rabbit recombinant Tissue Factor Molecular Weight: 46,000 Da
Intended use : Research Studies
Specifications :
About 50 µg of rabbit (rec) Tissue Factor lyophilized with additives and stabilizers. 50 µg (1 mL) #RE030A
RUO
Recombinant Hirudin
Intended use : Thrombin inhibitor which can be used in any in vitro laboratory research application where an efficient inhibition of Thrombin is required.
Specifications :
Activity 16,000 ATU/mg(ATU=Anti Thrombin Unit) 1 mg (1 mL) #RE020A
RUO
Relipidated Rabbit recombinant Tissue Factor Molecular Weight: 46,000 Da
Intended use : Research Studies
Specifications :
About 25 µg of relipidated rabbit (rec) Tissue Factor using a phospholipids mixture close to the activated platelet membrane for full expression of its clotting activity.
25 µg (1 mL) #RE031A
RUO
Streptokinase Molecular Weight: 47,000 Da
Intended use : Fibrinolysis studies. Activates Plasminogen.
Specifications :
Highly purified streptokinase, for Plasminogen assays, stabilized with albumin, freeze dried
1,000 U (1 mL) #EZ008A10,000 U (1 mL) #EZ008B
100,000 U (2 mL) #EZ008C
RUO
Miscellaneous
89
IMMUNOCHEMICALS
Polyclonal Antibodies
Anti-Annexin V
Intended use : Research reagent for all studies where a source of anti-Annexin V antibody is required.
Specifications :
Reacts with recombinant or native Annexin V 100 µg #PA120A
RUO
Anti-β2GP1
Intended use : Research reagent for all studies where a source of anti-β2GP1 antibody is required.
Specifications :
Reacts with the various forms of human β2GP1 100 µg #PA200A
RUO
Anti-Cytochrome C
Intended use : Research reagent for all studies where a source of anti-cytochrome C antibody is required.
Specifications :
Specific for Cytochrome C 100 µg #PA110A
RUO
Anti-Fibrinogen
Intended use : Research reagent for all studies where a source of anti-Fibrinogen antibody is required.
Specifications :
Reacts with the various forms of human Fibrinogen, Fibrin and degradation products 100 µg #PA140A
RUO
Anti-FPA
Intended use : Research reagent for all studies where a source of anti-FPA antibody is required.
Specifications :
Purified by immunoaffinity on immobilized human FPA Presents a cross-reactivity with fibrinogen 100 µg #PA100A
RUO
Anti-Prothrombin
Intended use : Research reagent for all studies where a source of anti-Prothrombin antibody is required.
Specifications :
Reacts with the various forms of human Prothrombin 100 µg #PA150A
RUO
90
Anti-human Factor IX
Intended use : Research reagent for all studies where a source of anti-Factor IX antibody is required.
Specifications :
Reacts with the various forms of human Factor IX 100 µg #PA160A
RUO
Anti-Factor X
Intended use : Research reagent for all studies where a source of anti-Factor X antibody is required.
Specifications :
Reacts with the various forms of human Factor X 100 µg #PA190A
RUO
Anti-PF4
Intended use : Research reagent for all studies where a source of anti-PF4 antibody is required.
Specifications :
Reacts with the various forms of human PF4 100 µg #PA130A
RUO
Anti-human Protein C
Intended use : Research reagent for all studies where a source of anti-Protein C antibody is required.
Specifications :
Reacts with the various forms of human Protein C 100 µg #PA170A
RUO
Anti-human Protein S
Intended use : Research reagent for all studies where a source of anti-Protein S antibody is required.
Specifications :
Reacts with the various forms of human Protein S 100 µg #PA180A
RUO
Anti-human Protein Z
Intended use : Research reagent for all studies where a source of anti-Protein Z antibody is required.
Specifications :
Reacts with the various forms of human Protein Z 100 µg #PA185A
RUO
91
Monoclonal Antibodies
Anti-h-PAI-1 Clone 1
Intended use : Immuno-chemistry. Research studies.
Specifications :
Murine monoclonal antibody specific for human PAI-1 100 µg (1 mL) #MA011A
RUO
Anti-h-PAI-1 Clone 2
Intended use : Immuno-chemistry. Research studies.
Specifications :
Murine monoclonal antibody specific for human PAI-1 100 µg (1 mL) #MA012A
RUO
Anti-h-PAI-1 substrate
Intended use : Immuno-chemistry. Research studies.
Specifications :
Murine monoclonal antibody specific for human PAI-1 100 µg (1 mL) #MA013A
RUO
ZYMUTEST Rat PAI-1 AgRat PAI-1 Immunoassay #RK001A
A two-site ELISA method for the measurement of rat PAI-1 antigen (Plasminogen-activator-inhibitor 1), on rat plasma or any other biological fluid where rat PAI-1 antigen must be measured. This assay is designed with two Murine monoclonal antibodies, specific for rat PAI-1, the first one for coating the microplate (immunocapture) and the second one, labelled with a Horse Radish Peroxidase (HRP) marker. Measures all PAI-1 forms, as well as the PAI-1 complexed with tPA.
Pres
enta
tion
12x8 test kit2x F-Sample Diluent3x rat PAI-1 Standard (rec.)1x high & low Rat PAI-1 Controls3x Anti-rat-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Detection Threshold : 0.1 ng/mLDynamic Range: 0-10 ng/mLIntra-Assay CV: 3-6%Inter-Assay CV: 4-8%
Intended use : Assay proposed for the measurement of rat PAI-1 antigen in research applications.
ZYMUTEST Rat PAI-1 ActivityRat PAI-1 Activity Immunoassay #RK003A
A two-site ELISA method for the measurement of rat PAI-1 activity (Plasminogen-activator-inhibitor 1), on rat plasma or any other biological fluid where rat PAI-1 activity must be measured. Uses active and stabilized tPA, bound onto the MicroELISA plate, for active PAI-1 capture. It is then revealed with a Murine monoclonal antibody, specific for rat PAI-1, and coupled with peroxidase (HRP).
Pres
enta
tion
12x8 test kit2x F-Sample Diluent3x Active rat PAI-1 Stan-dard (rec.)1x high & low Rat PAI-1 Controls3x Anti-rat-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid
Ass
ay c
hara
cter
isti
cs
Total Assay Time: 2h15Detection Threshold: 0.1 ng/mLDynamic Range: 0-10 ng/mLIntra-Assay CV: < 6%Inter-Assay CV: < 8%
Intended use : Assay proposed for the measurement of rat PAI-1 avtivity in research applications.
RUO
RUO
Rat Fibrinolysis
ANIMAL MODELS
92
93
Species/Factor Human Monkey
CynomolgusMonkeyRhesus Pig Goat Sheep Horse Dog Rabbit Guinea
Pig Rat Mouse
Annexin V + + + + ND ND + + + + + + + + + + + + + + + + + - + + + + + + + +
PF4 + + + + + + + + + + + + +/- + + + + + - - - + + + + + + + +
CRP + + + + + + + + + + + + - - - - - + + + + - - -
tPA Antigen + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +/- +/- +/-
PAI-1 Antigen + + + + + + + + + + - +/- +/- - - - - - -
Protein S, Free + + + + + + + + + + + + - - - - - - - - -
Protein S, Total + + + + + + + + - - - - - - - - -
B2GPI + + + + + + + + + + + + + + + +/- + + + + + - + + + + + + + +
Fibrinogen + + + + + + + + + + + + + + + + + + + + - - + +
Protein C + + + + + + + + + + + + +/- + + + + + + - - - +/- - -
Fibronectin + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + - + + + + + + + + + + + +
vWF + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + - + + + + + + +
Protein Z + + + + + + + + + + + + +/- + + + + + + + +/- + + + + +
Factor IX + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +/- + + + + + + + + + + + +
Factor X + + + + + + + + + + + + + + + + + + + + + - + + + + + + +
Factor XIII-A + + + + + + + + + + + + + + + + +/- + + - - -
ESTIMATION OF RESPECTIVE CROSS REACTIVITY
> 60 % 40 to 60 % 20 to 40 % 10 to 20 % 2 to 10 % < 2 %
+ + + + + + + + + + +/- -
Cross-reactivities with homologous animal proteins for the various ZYMUTEST Kits
Rat Biochemicals
Rat PAI-1 Standard
Intended use : Source of calibrated rat-PAI-1 protein
Specifications :
Lyophilized in presence of BSA 1 µg (1 mL) #RE001A
RUO
Rat PAI-1
Intended use : Research applications
Specifications :
Lyophilized in presence of BSA 10 µg (1 mL) #RE005O
RUO
94
GENERAL INFORMATION
GENE
RAL
INFO
RMAT
ION
PRICING AND ORDERING
Exclusive distributors available in most of the countries.
Please contact them directly for any product information, offer or for placing an order. Refer to the actualized list of distributors on the website:
www.hyphen-biomed.com
If no distributor is available in your country or if you do not find it:
Contact us directly: HYPHEN BioMed, SAS 155 rue d’Eragny 95000 Neuville-sur-Oise (France) Tel : +33.1.34.40.65.10 – Fax : +33.1.34.48.72.36 or +33.1.34.48.71.84 website: www.hyphen-biomed.com
95
96
TERMS AND CONDITIONS OF SALETERMS AND CONDITIONS OF SALE
1. Application of the General Terms & Conditions: These Terms & Conditions apply to all product sales entered into by Hyphen BioMed with its customers, irrespective of any other provisions appearing on any documents of the customer, in particular its terms & conditions of purchase, unless otherwise agreed to in writing by Hyphen BioMed. All orders placed with Hyphen BioMed entail acceptance of these Terms & Conditions. The contract of sale entered into between Hyphen BioMed and the customer will consist of the order, as accepted by Hyphen BioMed, and these Terms & Conditions (hereinafter the “Contract”).
2. Orders:Orders placed by telephone must be confirmed in writing, either by mail or by fax, and be marked “confirmation of telephone order of (date)”. Orders are only final following acceptance by Hyphen BioMed and will become firm and irrevocable as of acceptance.
3. Payment:The settlement of invoices related to the products must be made within 30 days following the date of the Hyphen BioMed invoice. Hyphen BioMed nevertheless reserves the right to request the payment of any order in cash after analysing the credit situation of the customer. In the event of any delay in payment, Hyphen BioMed may, without prejudice to its other rights and remedies, nor with any formal notice being necessary, (i) suspend all pending orders, (ii) invoice late payment penalties as of the day following the invoice due date by applying to the amount including taxes an annual interest equal to the closest reference rate applied by the ECB to its refinancing operations + 10 points, and (iii) apply a fixed compensation of €40 for recovery costs without prejudice to its right to claim any additional expenses incurred in recovery.
4. Price:The prices of Hyphen BioMed products are given excluding taxes. All taxes on turnover, value added, all registration fees, customs duties on imports or exports and, more generally, all taxes and duties charged by any governmental authority (including local or municipal authorities) are not included in the price of the products and will be payable by the customer in addition to the price.The prices appearing on the documents issued by Hyphen BioMed are not set for a determined duration and may vary between two orders. The price invoiced will be that of the applicable tariff on the day of the order. However, in the event of any increase in excess of 5% compared to the previous order, the customer’s prior consent will be requested to maintain the order.
5. Deliveries:5.1. Product deliveries will be made EXW from the laboratories of Hyphen BioMed, ZAC Neuville-sur-Oise, 155 rue d’Eragny, 95000 Neuville-sur-Oise, Incoterms 2010.5.2. The contract of carriage will nevertheless be concluded by Hyphen BioMed. Within metropolitan France, packaging and delivery/transport costs are borne by Hyphen BioMed for all orders higher than €230 excluding taxes; for all orders below €230 excluding taxes, a flat-rate charge for processing costs of €30 excluding taxes will be charged per order; for all urgent deliveries (less than 24 hours), an additional flat-rate charge of €23 excluding taxes will be charged per order, irrespective of the amount of the order. The cost of any special packaging (containers, insulators, dry ice or ice packs) necessary for certain deliveries will be borne by the customer, irrespective of the amount of the order. For all deliveries outside of metropolitan France, all packaging and delivery/transport costs shall be borne by the client.5.3. Irrespective of the delivery conditions, the goods travel at the risk and peril of the recipient, with no insurance subscribed by Hyphen BioMed, from the above-named place of delivery in accordance with the EXW rule of Incoterms 2010. In the event of loss or damage during transport, the customer must notify the carrier of any loss or damage noted within the deadlines set by law and inform Hyphen BioMed of such notification. 5.4. The delivery periods are indicative. No damages for delay may be claimed; the customer may however cancel the order one month following the issue of a formal notice to Hyphen BioMed remained without effect.5.5. Unless expressly agreed between Hyphen BioMed and the customer, no deliveries will be made on a Friday because of the weekend and the risk of inappropriate storage.
6. Non-conformity – Claims – Liability:6.1. Hyphen BioMed warrants that its products are in conformity with the specifications indicated in the order and the order acceptance as well as in the Hyphen BioMed catalogue. 6.2. Any claim for non-conformity concerning the order or defective product must be sent by means of registered letter with acknowledgment of receipt within a period of 7 days as from delivery of the products. Failing this, the products delivered will be deemed to be in conformity with the order as regards their quantity and quality.6.3. No products may be returned without the prior consent of Hyphen BioMed. Following the agreement of Hyphen BioMed and the allocation of a return number, return will be carried out at the expense and risk of the customer. The use of reagents in their entirety entails the waiving by the customer of any claim for non-conformity.6.4. The warranty provided by Hyphen BioMed is, at the choice of Hyphen BioMed, strictly limited to the free replacement of products recognised by Hyphen BioMed as non-conforming or defective or to their reimbursement by Hyphen BioMed, to the exclusion of any other damages for whatever cause or prejudice. This warranty will not apply in the event of any accident or negligence in the use of the products, nor of any usage, storage or handling of the products that does not comply with the instructions of Hyphen BioMed or industry standards, or in the event of any modification or intervention from the customer on the original products.6.5. To the full extent permitted by law, no other warranty than those mentioned in Article 7 and this Article 6 will be provided by Hyphen BioMed, in particular no warranty against hidden defects or warranty of title or non-infringement of third-party rights, of quality or conformity, or that the products are fit for any ordinary or particular purpose. To the full extent permitted by law, the liability of Hyphen BioMed is in any event limited to the amount of the sums received by Hyphen BioMed for the order in question; Hyphen BioMed may in no case be held liable for any commercial or intangible loss (including, but not limited to, any loss of profit, savings, business interruption or any loss arising from any third-party claim). The customer in this respect recognises that the prices set by Hyphen BioMed take account of the exclusions and limitations of liability and warranty provided under these Terms & Conditions and that, consequently, it must assume liability or insure itself for any damage or loss related to such exclusions and limitations. These exclusions and limitations are also applicable to any recourse by the customer’s insurers, either by direct action or subrogation.6.6. Hyphen BioMed will be released from its obligations under the Contract in cases of force majeure: in particular, war, riot, fire, floods, strikes, accidents, or the inability of Hyphen BioMed to receive supplies or ensure delivery of the products under reasonable conditions will all be deemed cases of force majeure.
7. Intellectual property: Hyphen BioMed warrants only that the products do not violate any intellectual property law in France. This warranty will not apply if the products are manufactured according to the specifications of the customer. In the event of any violation of intellectual property law, the warranty of Hyphen BioMed will be limited, at the choice of Hyphen BioMed, to the replacement of the products by non-infringing products, on acquisition at the expense of Hyphen BioMed of the right to use the products by the customer, or to the reimbursement of the sums received by Hyphen BioMed from the customer for the products in question.
8. Use: The Hyphen BioMed products are solely intended for in vitro use for the purposes of medical diagnosis. The use of the products by the customer shall in no way violate any law or regulation. For all pro-duct sales by Hyphen BioMed outside France, the customer will be liable, at its expense and risk, for ensuring the conformity of the products with any law or regulation applicable to the use or sale of the products in the country of destination of the products; in particular, the customer must ensure that any registration or other approval, any translation, labelling, instructions for use or other information or warning concerning the Contract or the products conform with the applicable laws or regulations of the country of destination of the products.
9. Retention of title:UNTIL SUCH TIME AS THE CUSTOMER MAKES FULL PAYMENT OF THE PRICE (INCLUDING ANY PENALTIES FOR LATE PAYMENT), HYPHEN BIOMED RESERVES THE RIGHT OF TITLE TO THE PRODUCTS SOLD, PERMITTING IT TO REPOSSESS SAID PRODUCTS. THE RISK OF LOSS OF OR DAMAGE TO THE PRODUCTS, AS WELL AS THE RISK OF ANY DAMAGE THEY MIGHT CAUSE, WILL NEVERTHELESS BE TRANSFERRED TO THE CUSTOMER AS OF DELIVERY OF THE PRODUCTS. THE CUSTOMER WILL CONSEQUENTLY, AT ITS EXPENSE, ARRANGE FOR THE INSURANCE OF THE PRODUCTS FOR THE BENEFIT OF HYPHEN BIOMED UNTIL THE FULL TRANSFER OF TITLE, WITH PROOF OF INSURANCE PROVIDED ON DELIVERY UPON REQUEST. THE CUSTOMER ALSO UNDER-TAKES TO STORE THE PRODUCTS SEPARATELY FROM ITS OTHER ASSETS AND CLEARLY IDENTIFY THEM AS BEING THE PROPERTY OF HYPHEN BIOMED UNTIL FULL PAYMENT OF THE PRICE. THE CUSTOMER WILL HAVE THE RIGHT TO USE OR RESELL THE PRODUCTS IN THE NORMAL COURSE OF BUSINESS, BUT THIS RIGHT WILL CEASE IMMEDIATELY IN THE EVENT OF NON-PAYMENT OF ANY SUM DUE TO HYPHEN BIOMED BY THE DUE DATE: HYPHEN BIOMED MAY IN THIS CASE REPOSSES THE PRODUCTS.
10. General: 10.1. If any provision of the Contract is declared invalid, ineffective or unenforceable, this will not affect the validity and enforceability of the other provisions and the parties will undertake to replace such provision with another valid provision which will have the closest possible economic effect. 10.2. The failure to exercise any right under this Contract will in no case entail the waiving of such right, which may subsequently be exercised by the party concerned.
11. Disputes:11.1. The Contract will be subject to and interpreted in accordance with French law. The 1980 United Nations Convention on Contracts for the International Sale of Goods will not apply to this Contract. 11.2. ANY DISPUTE ARISING FROM OR IN RELATION TO THIS CONTRACT WILL BE SUBJECT TO THE SOLE JURISDICTION OF THE COMMERCIAL COURT OF PONTOISE INCLUDING, BUT NOT LIMITED TO, ANY DISPUTE RELATING TO ITS INTERPRETATION, VALIDITY, PERFORMANCE OR TERMINATION, AND ANY SUMMARY PROCEEDINGS (PROCÉDURES EN RÉFÉRÉ) OR PROVISIONAL AND PROTECTIVE MEASURES (MESURES PROVISOIRES OU CONSERVATOIRES) NOTWITHSTANDING ANY NUMBER OF DEFENDANTS, ANY ACTION ON A WARRANTY OR GUARANTEE OR OTHER THIRD PARTY PROCEEDINGS AND ANY COUNTER-CLAIMS.
97
AActivated Partial Clotting Time (APTT) ................11, 13
Activated Protein C Chromogenic substrate ........................................75 Human enzyme .......................................................84
Activators (Protac®/Streptokinase) ..............................88
Activator Diluent Buffers and solutions for ELISA .........................59 Solutions for Microparticles ................................60
Adenosine-5’-diphosphate (ADP) ................................67
Aggregometry .....................................................................67
Alpha 1 Acid GlycoProtein (AGP) ..................................81
Alpha 2 anti-plasmin (chromogenic assay) ...............63
Anti-IIa activity See Direct Thrombin Inhibitors ..........................34 See Heparin .............................................................. 30 See Thrombophilia ................................................ 21
Anti-VIII Elisa kit ........................................................................13
Anti-Xa activity See Heparin ........................................................29, 30
Annexin V Control .................................................................52, 54 Elisa kit ........................................................................72 Polyclonal antibody ...............................................89 Recombinant human protein .............................83
Anti-Annexin V auto antibodies ....................................39
Anti-β2GP1 auto-antibodies ..........................................38
Anti-cardiolipin/Anti-Phospholipidantibodies (ACA/APA) .......................................................37
Anti-Protein C auto-antibodies ..............................39, 40
Anti-Protein S auto-antibodies ......................................40
Anti-Protein Z auto-antibodies .....................................41
Anti-Prothrombin auto-antibodies ..............................42
Antithrombin III Bovine protein ..........................................................86 Buffers .........................................................................57 Chromogenic assay ................................................21 Latex Immuno-assay ..............................................22 Human protein .........................................................78
Argatroban® (Calibrator & Control) ..............................49
Arachidonic Acid ................................................................67
Arixtra® (Calibrator & Control) ........................................47
Autoimmunity sample diluent ......................................59
Bβ2GP1 Buffer and solutions for ELISA ............................60 Elisa kit ........................................................................72 Human protein .........................................................78 Polyclonal antibodies ............................................89
Bentonite ...............................................................................60
CC4b-BP (human protein) ..................................................78
Calcium chloride ..........................................................57, 58
Calcium Thromboplastin ....................................................6
Calibrators .............................................................................43
Collagen .................................................................................68
Collagen Binding Assay (CBA) .......................................15
Control plasmas ..................................................................43
Conjugate Diluent ..............................................................59
C-Reactive Protein (CRP) Elisa kit ........................................................................70
Cytochrome C (Polyclonal antibody) ...........................89
DDabigatran (Calibrator & Control).................................50
D-Dimer Control ........................................................................53 Elisa kit ........................................................................26
Deficient Plasmas ...............................................................16
Dilution buffers ...................................................................59
Direct Thrombin Inhibitors (DTI) ...................................34
EEpinephrine .........................................................................67
FFactor II ......................................................see Prothrombin
Factor V Clotting method ......................................................10 Deficient plasma .....................................................16 Elisa kit ........................................................................10
Factor V-Leiden Calibrator ...................................................................48 Clotting method ......................................................25 Control ........................................................................48
Factor VII Chromogenic assay ................................................11 Clotting method ......................................................11 Deficient plasma......................................................16 Elisa kit ........................................................................11 Human protein .........................................................81
Factor VIIa (Chromogenic assay) ...................................12
Factor VII-X (Clotting method) .......................................12
Factor VIII:C Chromogenic assay ................................................12 Deficient plasma .....................................................17
Factor IX Chromogenic assay ................................................13 Deficient plasma......................................................17 Elisa kit ........................................................................13 Human protein .........................................................81 Polyclonal antibody ...............................................90
Factor IXa Chromogenic assay ...............................................14 Chromogenic substrate ........................................76 Control ........................................................................44 Human enzyme .......................................................84
Factor X
Bovine protein ..........................................................86 Chromogenic assay ...............................................14 Deficient plasma......................................................17 Elisa kit ........................................................................14 Human protein .........................................................81 Polyclonal antibody ...............................................90
Factor Xa Bovine enzyme ........................................................87 Chromogenic assay ...............................................34 Chromogenic substrate .................................74, 75 Fluorogenic substrate ...........................................76 Human enzyme .......................................................84
Factor XI Deficient plasma......................................................17
Factor XIa Chromogenic assay ...............................................14
Factor XII Deficient plasma......................................................18
Factor XIIa Human Enzyme .......................................................84
Factor XIII Deficient plasma......................................................18 Elisa kit ........................................................................15
Fibrin (fragment) .................................................................80
Fibrinolysis sample diluent .............................................59
Fibrino Peptide A (FPA) Buffer and solutions for ELISA ............................59 Polyclonal antibodies ............................................89 Elisa kit ........................................................................26 Control ........................................................................52
Fibrinogen Bovine protein ..........................................................86 Buffer and solutions for ELISA ............................60 Elisa kit ....................................................................8, 73 Human protein ..................................................78, 79 Fragments D, DD, E, E3t ........................................79 Latex immuno-assay ..........................................8, 72 Polyclonal antibody ...............................................89 Von Clauss Method....................................................8
Fibronectin Elisa kit ........................................................................73 Buffer and solutions for ELISA ............................60
HHeparin Chromogenic assay .........................................29, 30 Calibrators..................................................................45 Controls ......................................................................46
Heparin CoFactor II Chromogenic assay ................................................25 Human protein .........................................................80
Heparin dependent antibodies (Elisa kit) ...... 31 to 33
Hirudin Calibrators & Control.......................................49, 50 Recombinant Hirudin ............................................88
IImidazole buffer ..................................................................58
ALPHABETICAL INDEX
98
KKallikrein (Chromogenic substrate) .............................75
Kininogen (Deficient plasma) ........................................18
LLipoProtein a (Lp(a)) (Elisa kit) .......................................65
Low Molecular Weight Heparin (Control) ..................45
Lupus Anticoagulant Clotting method ...............................................26, 36 Controls ......................................................................36
Lyophilized platelets .........................................................68
MMicroparticles’ coagulant activity .................................27
NNon titrated human plasmas (Chromogenic assay) ....51
OOrgaran® (Calibrator & Control) .....................................47
PPhosphate-NaCl buffers ...................................................58
Plasminogen Activator Inhibitor-1 (PAI-1) Control .................................................................51, 54 Elisa kit (activity & Antigen) ..........................62, 65 Elisa kit (animal model) .........................................92 Protein (Animal model) .........................................93 Recombinant human protein .............................83 Monoclonal antibody ............................................91 Deficient plasma (tPA/PAI-1) ...............................19
Platelet aggregation ...................................................67, 68
Para-Nitro-Aniline (PNA) ..................................................56
Plasma factors and cofactors (Chromogenic assay) ........................................................44
PlasminChromogenic substrate ...................................................75Human enzyme ...................................................................85
Plasminogen Bovine protein ..........................................................86 Chromogenic assay .........................................62, 63 Human protein .........................................................79
Platelet Factor 4 (PF4) Control ........................................................................52 Elisa kit ........................................................................71 Human protein .........................................................82 Polyclonal antibodies ............................................90
Prekallikrein Deficient plasma......................................................18 Human protein .........................................................80
Protac® ...................................................................................88
Pro TAFI...................................................................................63
Protein C Chromogenic assay ................................................22 Clotting method ......................................................23 Deficient plasma......................................................19 Elisa kit ........................................................................23 Human protein .........................................................82 Polyclonal antibody ...............................................90
Protein S Clotting method ......................................................23 Control ........................................................................53 Deficient plasma......................................................19 Elisa kit (Free & Total) .............................................24 Human protein .........................................................82 Polyclonal antibody ...............................................90
Protein Z Deficient plasma......................................................19 Elisa kit ........................................................................24 Human protein .........................................................82 Polyclonal antibody ...............................................90
Prothrombin Bovine protein ..........................................................86 Buffer and solutions ...............................................57 Chromogenic assay ...............................................10 Deficient plasma......................................................16 Human protein .........................................................81 Polyclonal antibody ...............................................89
Prothrombin Time (PT) Clotting method .........................................................6
RRistocetin ...............................................................................68
Rivaroxaban (Calibrator & Control) .......................50, 51
SSample Diluents ...........................................................59, 60
Stop Solution .......................................................................60
Streptokinase .......................................................................88
Substrates ...........................................................59, 74 to 76
TThrombin Activatable Fibrinolysis Inhibitor (TAFI) Elisa kit .......................................................................63, Control ........................................................................52
Thrombin Bovine enzyme ........................................................87 Chromogenic substrate ........................................74 Clotting method .........................................................7 Human enzyme .......................................................84
Thrombin Time (T.T.) .............................................................7
Tissue Factor Elisa kits ...............................................................70, 71 Recombinant, rabbit ..............................................88
Tissue Plasminogen Activator (tPA) Elisa kits (Antigen & Activity) .......................64, 65 Plasma control...................................................52, 54 Recombinant human protein .............................83 Deficient Plasma (tPA/PAI-1) ...............................19
tPA and broad spectrum (Chrom. Substrate) ...........76
tPA stimulator ......................................................................80
Tetra-Methyl Benidine (TMB) .........................................59
Tris buffers .............................................................................57
UUnfractionated heparin Calibrator ............................................................45, 46 Control ........................................................................46Urokinase (Chromogenic substrate)............................76
Urokinase-type Plasminogen Activator (uPA) Control .................................................................52, 54 Elisa kits ......................................................................64 Human enzyme .......................................................85VVon Willebrand Factor (vWF) Deficient plasma......................................................19 Elisa kit ........................................................................15
WWash solutions .............................................................58, 60
99
INDEX BY REFERENCES
BIOPHEN® line220202 ............................................................... 34220412 ............................................................... 14220502 ............................................................... 63221003/221006 .............................................. 29221007 ............................................................... 29221010 ............................................................... 30221011/221013 .............................................. 29221020 ............................................................... 30221025 ............................................................... 30221030 ............................................................... 34221102/221105 .............................................. 21221111 ............................................................... 21221122 ............................................................... 21221202/221205 .............................................. 22221211 ............................................................... 22221304 ............................................................... 11221312 ............................................................... 12221402/221406 .............................................. 12221502 ............................................................... 62221511 ............................................................... 63221605 ............................................................... 10221705 ............................................................... 14221802/221805 .............................................. 13221812 ............................................................... 14221902 ............................................................... 25222001 ............................................................... 45222101 ............................................................... 44222201 ............................................................... 47222301 ............................................................... 45222401 ............................................................... 48222501 ............................................................... 47222601 ............................................................... 46222701 ............................................................... 50222801 ............................................................... 50223001/223801/224201 .............................. 46223101/223901/224101 .............................. 46223201 ............................................................... 44223301 ............................................................... 44223405 ............................................................... 48223501 ............................................................... 47223602/223605 .............................................. 51223701/224301/224401 .............................. 46224001 ............................................................... 47224501 ............................................................... 51224601 ............................................................... 44224701 ............................................................... 50224801 ............................................................... 45229001/C .......................................................... 74229005 ............................................................... 74229011 ............................................................... 74229014/C .......................................................... 74229015 ............................................................... 75229021 ............................................................... 75229031 ............................................................... 75229041 ............................................................... 75229051 ............................................................... 76229061 ............................................................... 76229091 ............................................................... 76
Aggregometry lineAG001K ............................................................. 67AG002K ............................................................. 67AG003K ............................................................. 67AG004K ............................................................. 68AG005K ............................................................. 68
AG006A/AG006K ........................................... 68
CEPHEN lineCK511K/ CK512K ...............................................6CK515K/L .............................................................6CK521K/ CK522K ...............................................7
ELITEST lineCK101A .............................................................. 65CK102A .............................................................. 65CK103A .............................................................. 65
FIBRIPHEN lineCK571K/ CK572K/ CK575K .............................8
FLUOPHEN line329011 ............................................................... 76
HEMOCLOT lineCK001K/L .............................................................7CK002K/L .......................................................... 34CK011K/L .............................................................7CK031K .............................................................. 23CK041K .............................................................. 23CK051K/L .......................................................... 12CK061K/L .......................................................... 25CK065K .............................................................. 25CK071K .............................................................. 10CK081K .............................................................. 11CK090K ....................................................... 26, 36CK091K ....................................................... 27, 36
LIAPHEN® line120002 ............................................................... 22120102 ............................................................... 72
THROMBOPHEN lineCK550K/M/L ........................................................6CK551K/M/L ........................................................6
ZYMUPHEN line521096 ............................................................... 27521196 ............................................................... 27521296 ............................................................... 64
ZYMUTEST lineRK001A .............................................................. 92RK003A .............................................................. 92RK004A .............................................................. 72RK005A/B .......................................................... 39RK006A .............................................................. 71RK007A/B .......................................................... 42RK008A .............................................................. 63RK009A .............................................................. 10RK010A .............................................................. 70RK011A .............................................................. 64RK012A .............................................................. 62RK013A .............................................................. 64RK014A/B/C ..................................................... 38RK015A .............................................................. 24RK016A .............................................................. 26RK017A .............................................................. 64RK018A .............................................................. 65RK019A .............................................................. 62RK020A/B .......................................................... 40
RK021A .............................................................. 24RK022A .............................................................. 72RK023A .............................................................. 26RK024A .............................................................. 73RK025A/B .......................................................... 41RK026A/B ................................................... 39, 40RK027A .............................................................. 23RK028A .............................................................. 73RK029A/B/C ..................................................... 37RK030A .............................................................. 15RK031A .............................................................. 24RK032A .............................................................. 13RK033A .............................................................. 14RK034A .............................................................. 15RK035A .............................................................. 70RK036A .............................................................. 11RK037A .............................................................. 63RK038A .............................................................. 15RK039A .............................................................. 13RK040A .............................................................. 31RK040B .............................................................. 31RK040C .............................................................. 31RK040D .............................................................. 32RK040E............................................................... 32RK041A .............................................................. 33RK041D .............................................................. 33RK042A .............................................................. 71
Auxiliary reagentsAR001A/K ......................................................... 57AR002A/K ......................................................... 58AR004A/K ......................................................... 58AR005A/K ......................................................... 58AR006A/K ......................................................... 58AR007A/K ......................................................... 58AR008A/K ......................................................... 56AR009A/K ......................................................... 56AR010A .............................................................. 59AR011A/K ......................................................... 59AR012A .............................................................. 56AR013A .............................................................. 59AR014A .............................................................. 56AR015A/B ......................................................... 56AR016A .............................................................. 59AR017A .............................................................. 59AR018A .............................................................. 59AR019A .............................................................. 60AR020A .............................................................. 57AR021A/K/L ..................................................... 58AR022A .............................................................. 57AR023A .............................................................. 60AR024A .............................................................. 60AR025A .............................................................. 60AR026A/K ......................................................... 57AR027A .............................................................. 56AR103A .............................................................. 57AR104A .............................................................. 57
Bovine EnzymesBE101C/D/L/O/K/B ........................................ 87BE102A/K/B/C/................................................ 87BE501C/K .......................................................... 87
Bovine ProteinsBP101O/K/A/B ................................................ 86BP102A/K .......................................................... 86
100
BP103A/K .......................................................... 86BP104C .............................................................. 86BP105C .............................................................. 86
Deficient plasmasDP010A/K ......................................................... 16DP020A/K ......................................................... 16DP030A/K ......................................................... 16DP040A/K ......................................................... 17DP050A/K ......................................................... 17DP060A/K ......................................................... 17DP070A/K ......................................................... 17DP080A/K ......................................................... 18DP100A/K ......................................................... 19DP110A/K ......................................................... 19DP120A/K ......................................................... 19DP150A/K ......................................................... 19DP200A/K ......................................................... 18DP210A/K ......................................................... 19DP300A/K ......................................................... 18DP310A/K ......................................................... 18
Human EnzymesEZ004A/B/C ..................................................... 84EZ005A/B/C ..................................................... 85EZ006O/K/A/L/B ............................................. 84EZ007A/K/B/L/C ............................................. 84EZ008A/B/C ..................................................... 88EZ010B .............................................................. 84EZ011A/B .......................................................... 88EZ012A/K .......................................................... 84EZ013A/B .......................................................... 85
Monoclonal AntibodiesMA011A ............................................................ 91MA012A ............................................................ 91MA013A ............................................................ 91
Polyclonal AntibodiesPA100A .............................................................. 89PA110A .............................................................. 89PA120A .............................................................. 89PA130A .............................................................. 90
PA140A .............................................................. 89PA150A .............................................................. 89PA160A .............................................................. 90PA170A .............................................................. 90PA180A .............................................................. 90PA185A .............................................................. 90PA190A .............................................................. 90PA200A .............................................................. 89
Purified ProteinsPP001A/K/B/C/R ............................................. 78PP002A/K/B/C ................................................. 79PP003A .............................................................. 82PP004A/K/B/L/D/M/C ................................... 78PP005A/B/C ..................................................... 80PP006B/K .......................................................... 81PP007A .............................................................. 81PP008A .............................................................. 81PP009A .............................................................. 82PP010A .............................................................. 78PP011A .............................................................. 82PP012A .............................................................. 82PP013A .............................................................. 81PP014A/C .......................................................... 80PP015A .............................................................. 78PP016A .............................................................. 79PP017A .............................................................. 79PP018A .............................................................. 79PP019A .............................................................. 79PP020A .............................................................. 80PP021B/K .......................................................... 80PP201A .............................................................. 81PP501B/K .......................................................... 80
Recombinant Human ProteinsRP004A .............................................................. 83RP005A .............................................................. 83RP006A .............................................................. 83RP007A/C.......................................................... 83
Recombinant Proteins
RE001A .............................................................. 93
RE005O .............................................................. 93RE020A .............................................................. 88RE030A .............................................................. 88RE031A .............................................................. 88
Standard and ControlsSC011K .............................................................. 51SC011K/E .......................................................... 54SC013K .............................................................. 52SC014K .............................................................. 52SC015K .............................................................. 52SC017K .............................................................. 52SC017K/E .......................................................... 54SC020K/L .......................................................... 49SC025K .............................................................. 50SC030K .............................................................. 49SC035K .............................................................. 49SC050K .............................................................. 53SC065K .............................................................. 48SC080K .............................................................. 36SC081K .............................................................. 36SC101K .............................................................. 53SC102K .............................................................. 53SC103K .............................................................. 53
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