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MULTIPLEX GENOTYPING TESTS FOR DETECTION OF RED BLOOD CELL AND HUMAN PLATELET ANTIGENS

At Grifols, we know that your primary concern in blood transfusions

is to ensure patient safety. After seventy years of experience in

the field of transfusion medicine we have demonstrated that

safety is also our number one priority.

Blood group compatibility between donor and patient is the key

to guaranteeing this safety. For more than twenty years, Grifols

has researched and developed blood typing systems that have

enabled millions of safe transfusions to be performed all over

the world.

Hemagglutination tests have been used for many years to

identify blood group antigens, with highly satisfactory results.

Unfortunately, in certain instances serology may be unpractical,

or the reliability of the results may be compromised.

Recently, DNA-based testing has proved to be an extremely

effective technique that can, in certain situations, offer

advantages over current serology techniques.

BLOODchip® is a fast and effective solution for typing the most

clinically relevant blood group antigens. The test provides

detailed information to ensure maximum compatibility between

the patient and the donor so that you can offer the safest

transfusion therapy possible.

Why is serology sometimes unreliable?Serological results may be difficult to interpret leading to inconclusive results. In such cases more than one methodology may be required to successfully type a patient, which is time consuming and costly.

How does genotyping overcome current limitations of serology?Molecular analysis for determining blood group phenotypes directly determines alleles that code for surface antigens.

In which cases is genotyping a better option? Transfusion dependent patients (with sickle-cell disease, thalassemia or cancer), who are at risk of alloimmunization can benefit from individualized RBCs through extended antigen matching.1

When RBC’s are coated with antibodies. In patients showing a positive direct antiglobulin test due to in vivo sensitization.2

When patients have had recent transfusions, it is difficult to phenotype red blood cells (RBC) and unreliable results can occur. 2

The presence of certain variant antigens can cause false-negative reactions (Duffy b weak) or inaccurate results in patients (Partial C in r’s individuals) depending on the method of testing or the source of the reagent antisera.1

Why is it more practical to genotype? The ability to perform extended phenotype-serology testing on all donors is limited. Reagent antisera for rare and minor antigens are often unavailable and costly. Holding an inventory of such reagents may not be viable for many blood banks.2

Molecular-based methods have higher throughput, and eliminate the variation inherent in serology. Molecular methods can also reduce the costs of reagent antisera and problems associated with supply shortages.3 The characterization of donor phenotypes makes it possible to develop database of donor. 2

What are the benefits?FOR THE BLOOD BANK

Better quality of life for patients 1

Reduce hospital admission time before and after the transfusionExtend the period between transfusions 1

Reduce adverse reaction 1

Gain cost-efficiency: Reduce labor costs and reagent costs 3

A wide spectrum of antigens with a single test 2

Build a comprehensive donor database 2

Better use of negative or rare blood units 2

Faster turn around time 2

FOR THE HOSPITAL/PATIENT

1 Red blood cell alloimmunization in sickle cell disease and in thalassaemia: current status, future perspectives and potential role for molecular typing. Matteocci A. and Pierelli L.; VoxSanguinis (2014) 106, 197. 2 Blood group molecular genotyping. Jungbauer C; ISBT Science Series (2011) 6, 399. 3 Set-up and routine use of a database of 10555 genotyped blood donors to facilitate the screening of compatible blood components for alloimmunized patients. Perreault J. et al; VoxSanguinis (2009) 97,61.

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MULTIPLEX PCR HYBRIDIZATION LABELINGSIGNAL DETECTION(LUMINEX)

PROCEDURE WORKFLOW

ID CORE XT analyzes 29 polymorphisms determining 37 antigens of RBC48 tests per kitProved accuracy including r’sBased on Luminex technology

Main applications:

Asses the presence/absence of blood groups in chronically and recently transfused patients

Screen routine donors

Select compatible donors for alloimmunized patients

Complement serological panel with further antigen identification

RhCE

Kell

Kidd

Duffy

MNS

Diego

Dombrock

Colton

Cartwright

Lutheran

RHCE*ce; RHCE*Ce, RHCE*cE; RHCE*CE, RHCE*CeCW, RHCE*ceCW, RHCE*CECW, RHCE*ceAR, RHCE*CeFV, RHCE*CeVG , RHCE*cEFM, RHCE*ce[712G] , RHCE*ce[733G] , RHCE*ce[733G,1006T] , RHCE*CE-D[2, 5,7]-CE, RHCE*cE[697G,712G,733G] RHD*r’s-RHCE*ce[733G,1006T]

BLOODGROUPS

ALLELES ASSAYED PREDICTED PHENOTYPES (Antigens)

C (RH:2), E (RH:3), c (RH:4),e (RH:5), CW (RH:8),V (RH:1 0), hrS (RH:19), VS (RH:20), hrB (RH:31)

K (KEL:1), k (KEL:2),Kpa (KEL:3),Kpb (KEL:4),Jsa (KEL:6), Jsb (KEL:7) Jka (JK:1), Jkb (JK:2)

Fya (FY:1), Fyb (FY:2)

M (MNS:1), N (MNS:2), S (MNS:3),s (MNS:4),U (MNS:5), Mia (MNS:7)

Dia (DI:1), Dib (DI:2) Doa (DO:1), Dob (DO:2),Hy (DO:4), Joa (DO:5)

Coa (CO:1), Cob (CO:2) Yta (YT:1), Ytb (YT:2)

Lua (LU:1), Lub (LU:2)

KEL*K_KPB_JSB, KEL*k_KPB_JSB KEL*k_KPA_JSB, KEL*k_KPB_JSA

JK*A, JK*B, JK*B_null(871C),JK*B_null(IVS5-1a) FY*A; FY*B, FY*B_GATA,FY*B[265T]_FY*X GYPA*M, GYPA*N, GYPB*s, GYPB*S, GYPB*Mur, GYPB*deletion , GYPB*S_null(230T) , GYPB*S_null(IVS5+5t) DI*A, DI*B DO*A, DO*B, DO*B_HY-, DO*A_JOA-

CO*A, CO*B YT*A, YT*B LU*A, LU*B

From 1 to 96 samples per run ID CORE XT and ID HPA XT can be performed in the same run

One multiplex PCR No filtration required Only 4 tubes to pipette

< 4 hours overall time from DNA to result 30 min hands on time

EASY FAST FLEXIBLE

Main applications:

Platelet antigen typing in donor and patients

Perform large-scale donor typing for provision of antigen-negative platelets

Help to select compatible platelet donors for refractory or alloimmunized patients

Complement clinical history of alloimmune platelet disorders, such as foetal and neonatal alloimmune thrombocytopenia (FNAIT), post-transfusion purpura and platelet ransfusion refractoriness

ID HPA XT analyzes 13 polymorphisms determining 12 HPA Systems48 tests per kitBased on Luminex technology

HPA-1

HPA-2

HPA-3

HPA-4

HPA-5

HPA-6

HPA-7

HPA-8

HPA-9

HPA-10

HPA-11

HPA-15

HPA1a, HPA1b

HPA2a, HPA2b

HPA3a, HPA3b

HPA4a, HPA4b

HPA5a, HPA5b

HPA6a, HPA6b

HPA7a, HPA7b

HPA8a, HPA8b

HPA9a, HPA9b

HPA10a, HPA10b

HPA11a, HPA11b

HPA15a, HPA15b

HPA-1a, HPA-1b

HPA-2a, HPA-2b

HPA-3a, HPA-3b

HPA-4a, HPA-4b

HPA-5a, HPA-5b

HPA-6bw

HPA-7bw

HPA-8bw

HPA-9bw

HPA-10bw

HPA-11bw HPA-15a, HPA-15b

HUMAN PLATELET ANTIGEN SYSTEMS

ALLELES ASSAYED PREDICTED PHENOTYPES (Antigens)

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BLOODchip® ID Software optimally handles the genotyping procedure and data

WORKFLOW TRACEABILITY

BIDS XT provides with plate configuration, kit and enzyme lot registration functions to help users to trace sample, reagents and results Also provides with worksheet print-outs with volumes and guidelines to support users with the procedure

DATABASE & MULTIPLE-SEARCH FUNCTION

It is a comprehensive data base for samples, clinical information and test results Multiple search functions, including phenotypes and genotypes searching tools, helps users to find the appropriate units or patients

CLEAR RESULTS

Friendly and detailed reports Results by sample or batch of samples Multiple formats (.xls, .pdf) to adapt to users’ needs Raw data graphs for a detailed comprehension of results

CONNECTIVITY

Bidirectional connection with LIS Connection with Luminex to simplify the procedure Provide results automatically, no user intervention for interpretation

PERFORMANCE AND QUALITY CONTROL

Provides management of positive and negative controls

AUDITS

Registers of all actions performed by users

INTUITIVE

COMPREHENSIVE

CONFIGURABLE

FLEXIBLE

221239

221238

221240

ID CORE XT

ID HPA XT

BIDS XT

48 tests

48 tests

1 unit

Genetic identification panel for 37 RBC Antigens by DNA analysis

Genetic identification panel for 12 Human Platelet Antigen Systems by DNA analysis

BLOODchip® ID Software XT

Reagents & SoftwareReference Product Product Description Size

220973 Luminex® 200(TM) System with xPONENT® Software

1 unitLuminex 200 System with xPONENT Software and PC/Flat Panel Monitor

EquipmentReference Product Product Description Size

ID CORE XT, ID HPA XT and BIDS XT comply with the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices. CE Mark Certification.

ID CORE XT, ID HPA XT and BIDS XT are sold in the US for research use only. Not for use in diagnostic procedures.

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BLOODchip® Service is a practical and efficient way to conduct blood group genotyping. No investment or minimum volume

of samples is required; simply send your samples to our Reference Laboratory in Medford, US.

BLOODchip® Service provides Immunohematology Laboratories:

The possibility of performing tests with the complete

BLOODchip® product portfolio and the latest

sequencing technologies

Assistance and scientific support for

challenging cases

An easy and detailed report

* Clinical Laboratory Improvement Amendments (CLIA) are United States federal

regulatory standards that apply to all clinical laboratory testing performed on humans

(in the United States) to ensure the accuracy, reliability and timeliness of the results.

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9007791

9007792

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9007417

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9007420

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9007421

BLOODchip® Reference Analysis

BLOODchip® ID CORE XT Analysis

BLOODchip® ID HPA XT Analysis

H Phenotype Analysis

ABO Antigen Analysis

RHD Zygosity Analysis

RhD Antigen Analysis

RHCE Antigen Analysis

Minor Antigens I Analysis

Minor Antigens II Analysis

Custom Sequencing Assay Development

Service STAT processing

DNA extraction

Genomiphi Amplification

1 sample

1 sample

1 sample

1 sample

1 sample

1 sample

1 sample

1 sample

1 sample

1 sample

1 sample

1 sample

1 sample

1 sample

DNA analysis for more than 10 groups of the RBC (including ABO and RhD) and 12 HPA

DNA analysis for 37 RBC Antigens

DNA analysis for 12 Human Platelet Antigen Systems

FUT1 sequencing analysis

ABO sequencing analysis

RHD Zygosity PCR fragment analysis

RhD sequencing/exon scanning analysis

RHCE sequencing/exon scanning analysis

DNA sequencing for Kell, Kidd, Duffy or MNS antigen analysis

DNA sequencing for Diego, Dombrock, Colton, Cartwright or Lutheran antigen analysis

Customized DNA assays

For emergency samples

DNA extraction from blood and saliva samples

Whole genome amplification

BLOODchip® ServiceReference Product Product Description Size

Reference Laboratory Service

CLIA* certified procedures and assays guarantees confident results. Please contact Grifols local representative for further details.

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Grifols International, S.A.

Parc Empresarial Can Sant JoanAv. de la Generalitat, 152-15808174 Sant Cugat del VallèsBarcelona - SPAIN

Tel. (+34) 935 710 500Fax. (+34) 935 710 267

Progenika Biopharma, S.A.Parque Tecnológico de Bizkaia Ibaizabal bidea, Edificio 504 48160 Derio, Bizkaia – SPAIN

www.grifols.com