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ECAT FOUNDATIONExternal quality Control for Assays and Tests
With a focus on Thrombosis and Haemostasis
REPORT
SURVEY 2015-1lupus Anticoagulantlabeode 9907152
Copyright @ 2015ECAT Foundation
[CATFOUNDATlON
External qua/ity Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2015-1
Page 30f2012-May-2015Labeode: 9907152
Date of Issue
Survey
Report
12-May-2015
2015-1
Lupus Anticoagulant
Note:In the Survey Manual 2015 detailed information is given regarding the ECAT external quality assessment programme,including the statistical evaluation and explanation of the report.This Survey Manual 2015 should be considered as an integral part of this survey report.
Generalinformation
Currently there are 536 participants registered for the Lupus Anticoagulant module. In totally 483 participants havesubmilted results. The response rate is 90%.
P.MeijerExecutive Director
Note: A printed version of the actual Survey Manual is provided to all participants once a year. This manual can also bedown loaded from the member section of the ECAT website.
[CATFOUNDATION
ILupus Anticoagulant
No. of Responders304
Externa/ qua/ity Contro/ for Assays and TestsWith a foeus on Thrombosis and Haemostasis
I IScreening
Survey: 2015-1
Page 5 012012-May-2015Labcode: 9907152
Sampie NoSampie Details
Stability
Homogeneily
15.17Plasma strongly positive lor Lupus AnticoagulantUnits: RatioPrior Use: None
31-January-2017
2.1 %
Assay Normal Borderline Prolonged No Your resultClassification
Screening 1 Screening 2 Screening 3APTT 2 2 330 5dAPTT 1 0 16 0dPT 1 0 9 0dRVVT 1 1 440 10 Prolonged ProlongedKCT 0 0 9 0Other 0 0 1 0PNP 0 0 2 1PT 0 0 3 0SCT 0 0 73 5
[CATFOUNDATION
ILupus Anticoagulant
No. of Responders198
External qua/ity Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis
11 Mixing
Survey: 2015-1
Page 7 of 2012-May-2015Labcode: 9907152
Sampie NoSampie Details
Stability
Homogeneity
15.17Plasma strongly positive for Lupus AnticoagulantUnits: RalioPrior Use: None
31-January-2017
2.1 %
Assay Normal Borderline Prolonged No Your resullClassification
Mixing 1 Mixing 2 Mixing 3APTT 12 6 241 3dAPTT 1 0 23 0dPT 0 0 5 0dRVVT 4 2 240 3KCT 0 0 12 0Olher 0 0 2 0PNP 0 0 3 0PT 1 0 1 0SCT 1 0 36 0
Ratio n 81!lsignedCV (%) rangevalue
panel 1 z-score panel 2 z-score panel 3 z-score
APTT 228 1.67 21.3 0.86 - 3.59I.L. APTT SP 25 2.08 5.5 1.76 - 2.29I.L. HemoslL SynthAsil 20 1.82 9.1 1.46 - 2.25I.L. Mixeon 12 1.76 12.1 1.16-2.17Siemens Actin FSl 38 1.31 13.6 0.86 -1.65Siemens Pathromtin SL 17 1.32 8.5 1.16-1.79Stago/Roche PTT 21 1.46 7.8 1.11.2.00Slago/Roche PTT LA 60 1.80 8.3 1.09 - 2.87Trinity Biotech Automated APTT 8 1.42 1.23.1.64Trinity 8iotech TriniClot APTI-HS 7 1.63 1.50 - 3.59dAPTT 22 1.80 16.0 1.29 - 2.91Stago/Roche PTT LA 11 1.80 9.1 1.62.2.40dRWT 225 1.80 9.6 0.90 - 2.71American Diagnostics DWtest 5 1.93 1.36 - 2.01I.L. HemoslL dRWT screen 40 1.91 8.8 1.60 - 2.71Life Diagnostics LA screen 10 1.91 6.9 1.62 - 2.09Precision Biologie LA check 8 2.34 2.05 - 2.44Siemens LA1 screen 101 1.74 7.9 1.01 - 1.99Siemens lA2 confirmation 7 1.53 0.90.1.728tago I Rache DRWT screen 39 1.83 7.7 1.50 - 2.62KCT 10 2.51 44.7 0.22 - 4.62SCT 36 2.60 26.9 0.49 -7.11Haematex SACT Reagent 8 3.26 0.49-7.11I.L. SeT screen 27 2.57 18.5 0.98 - 3.55
[CATFOUNDATION
Extemal qua/ity Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis
Survey: 2015-1
Page 9 012012-May-2015Labeode: 9907152
ILupus Anticoagulant
No. 01 Responders239
I IConfirmation
Sampie NoSampie Details
Stabilily
Homogeneily
15.17Plasma strongly positive lor Lupus AntieoagulantUnits: RatioPrior Use: None31-January-2017
2.1 %
Assay Positive Borderline Negative No Your resultClassilieation
Confirm 1 Confirm 2 Confirm 3APTT 133 2 5 2dAPTT 10 1 1 0dPT 8 0 0 0dRVVT 452 8 4 2 LA Positive LA PositiveKCT 1 0 0 0Other 1 0 0 0PNP 13 0 3 0PT 2 0 1 0SCT 69 0 0 0
Ratio n ISligned CV (%) rangevalue
panel 1 z-score panel 2 z-score panel 3 z.score
APTT 91 1.37 17.3 0.37 - 4.671.L. Hemosil SynthAFax 12 1.24 3.4 1.19 -1.53I.L. Mixeon 11 1.49 31.1 1.12-2.20Siemens Actin FS 34 1.24 7.2 1.08 - 1.46Sta9o/Roche Slaclot LA 13 1.62 46.4 0.37 - 4.67Technoclone Lupus Anticoagulant Test 6 2.72 1.89 - 3.89dAPTT 7 1.33 1.20 -1.57dPT 7 1.58 1.41-1.90dRWT 388 1.27 84 0.95 - 3.27 1.18 -0.84 1.25 -0.22American Diagnostics DWconfirm 9 1.33 1.23-1.51I.L. HemoslL dRVVT confirm 93 1.27 7.7 1.02 - 2.46I.L LAC confirm 22 1.27 8.2 1.10-2.27Life Diagnostics LA confirm 16 1.23 10.8 1.06-1.43Precision Biologie LA sure 14 1.30 14.1 1.06 - 3.27Siemens lA2 confirmation 142 1.26 7.4 0.95 - 2.50 1.18 -0.80StagoiRoche DRWT Confirm 70 1.28 8.8 1.08 - 2.00Technoclone LA Confirm 7 1.25 1.10-1.30 1.25PNP 6 1.49 0.77-2.11SeT 64 1.48 10.7 0.69 - 3.10I.L seT confirm 63 1.48 10.9 0.69 - 3.10
ECATFOUNDATION
External quality Control {ar Assays and TestsWith a {oeus on Thrombosis and Haemostasis
Survey: 2015-1
Page 11 012012-May-2015Labeode: 9907152
ILupus Anticoagulant
No. of Responders483
IRatio Screening/Confinnation
Sam pie NoSampie Details
Stability
Homogeneity
15.17Plasma strongly positive lor Lupus AnticoagulantUnits: RatioPrior Use: None
31-January-2017
2.1 %
Ratio Screening/Confirmation n IIsslgned CV (%) rangeYldue
panel 1 z-score panel 2 z.score panel 3 z-score
APTT 177 1.64 19.6 1.09 - 2.64dAPTT I 6 1.70 1.12-2.02dRVVT 438 1.99 10.6 1.09 - 3.14 2.02 0.16 1.97 .0.08SeT I 66 2.42 12.5 1.68 - 5.81
Assays
'80
180
,.0120
c6100()
60
40
20
.'",
[CATFOUNDATION
ILupus Anticoagulant
No. of Responders206
Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
IAntiCardiolipin Antibodies IgG
Survey: 2015-1
Page 13012012-May-2015Labeode: 9907152
Sampie NoSampie Details
Stabilily
Homogeneily
15.17Plasma strongly positive lor Lupus AnticoagulantUnits: GPL, ~g/mL, OtherPrior Use: None
31-January-2017
2.1 %
Classification Negative Borderllne Low Positive MedIum Positive High Positive No Conc1usion
I Total 4 1 1 17 182 1
IgG n Blllligned CV (%)value
range Your result z-score
'fatal Group • , - . ",,"GPL 137 142.4 42.9 0.0 - 2752.0Corgenix REAADS 7 83.6 54.6 - 121.0Euroimmun 9 120.0 5.1 - 245.0INOVA Diagnostics lnc. 22 98.7 11.5 42.7 - 198.0Orgentec 14 106.2 29.4 68.8 - 228.8Orgentec (Alegria) 5 120.0 91.5 - 188.0Phadia 53 184.9 14.4 21,3 - 230.0~g1mL 1 1.2 1.2 -1.2Other 25 1020.2 20.3 2.6 -1574.0I.L. Acustar 17 1063.5 15.8 840.0 - 1574.0
"20
"",oo 12
4
°:2~fe~f8SiI:;~~~Ol(,")r--. .NN"':"':O<riaic:ei<ri""':<D<DlI'ill'i;1;•....N'<t1D a;l(J)•....MIt) •.•..m •....C") It)Nv •..•••• ..- •••••• NNNA
.Otller .INOVA .Orgentec
.Phadll
[CATFOUNDATlON
I Lupus Anticoagulant
No. of Responders186
External qua/ity Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
IAntiCardiolipin Antibodies IgM
Survey: 2015-1
Page 15 012012-May-2015Labeode: 9907152
Sampie NoSampie Details
Stability
Homogeneity
15.17Plasma strongly positive lor Lupus AnticoagulanlUnits: MPL, IJg/mL, OtherPrior Use: None31-January-2017
2.1 %
ClassificationNegative Bordertine Low Positive Medium Positive High Positive No Conclusion
I Total 136 18 27 2 2 1
IgM n asalgned CV (%)value
range Your result z-score
iTöläl GroUIl -MPL 154 6.9 46.6 0.6 - 32.0Aeskulisa Diagnotic GmbH 5 6.7 1.2-16.0Bio-rad 7 11.2 9.0 - 14.0Corgenix REAADS 7 14.3 11.0-16.0Euroimmun 11 6.4 32.6 0.6 -15.4INOVA Diagnostics Ine. 21 16.6 25.4 11.0 - 30.5Orgentec 16 6.2 16.9 5.0 -12.6Orgentec (Alegria) 13 6.7 27.0 4.6 - 11.4Phadia 49 6.1 17.6 4.0 - 6.5~glmL 1 0.2 0.2 - 0.2Other 21 9.6 23.1 0.6-31.3I.L. Acustar 15 9.9 14.0 6.2 -13.2
70
c,ou
.00""
.Orgllnlec.Eurolmmun .INOVA• Oroenlec (Aleoria) • Phadia
[CATFOUNDATION
Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2015-1
Page 17 of 2012-May-2015Labeode: 9907152
ILupus Anticoagulant
No. of Responders175
Iß2-Glycoprotein I Antibodies IgG
Sam pie NoSam pie Details
Stability
Homogeneity
15.17Plasma strongly positive for Lupus AnticoagulantUnits: U, ~g/mL, OtherPrior Use: None
31.January.2017
2.1 %
Classification Negative Borderline Low Positive Medium Positive High Positive No Conclusion
I Tolal 2 2 5 23 142 1
IgG n BSligned CV (%)value
range Your result z-score
Ratio 26 8.5 104.0 0.5 - 8.8.
U 113 125.1 48.0 5.4 - 1300.0Aeskulisa Diagnotic GmbH 8 19.3 5.4 - 58.0Corgenix REAADS 7 154.2 137.0 -184.1INOVA Diagnostics Inc. 18 68.3 36.1 12.1-108.3Orgentec 15 98.5 24.2 66.6 -141.0Phadia 47 163.9 14.0 55.0 - 204.0~glmL 1 1.2 1.2 - 1.2Qther 29 3772.1 96.1 3.2 - 8059.8Euroimmun 8 192.1 4.4 - 317.0I.L. Acustar 13 6383.0 20.3 4674.2 - 8059.8
y.
14
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8
[(ATFOUNDATION
Extemal qua/ity Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2015-1
Page 19 of 2012-May-2015Labeode: 9907152
I Lupus Anticoagulant
No. of Responders149
Iß2-Glycoprotein I Antibodies IgM
Sampie NoSampie Details
Stability
Homogeneity
15.17Plasma strongly positive for Lupus AnticoagulantUnits: U, IJg/mL, OtherPrior Use: None
31-January-2017
2.1 %
Classlficatlon Negative Borderllne low Positive Medium PosItive HIgh Positive No Concluslon
I Total 108 18 13 8 2 0
IgM n lIsalgned CV (%)vatue
Your re5uft z-score
Ratio 23 1.4 74.1 0.1-7.0.
Seleet trom list 3 10.0 6.0 -10.7U 104 7.8 46.3 1.0.54.7Aeskulisa Diagnotic GmbH 6 2.8 1.0 -13.0Corgenix REAADS 6 18.1 14.8 - 22.0INOVA Diagnostics Inc. 12 11.6 12.9 9.7 -54.1Orgentec 15 6.4 21.4 2.5 - 7.8Orgentec (Alegria) 11 4.4 33.3 1.7-18.8Phadia 37 6.6 16.8 4.0 - 9.4~glmL 3 6.0 0.2 - 9.1Other 34 15.8 86.5 0.5 - 104.0Euroimmun 7 59.0 51.0 -104.0I.L. Acustar 12 9.9 12.2 8.3-13.7
"
c,oU 12
4
.Olller .INOVA
.OfvenlllC(Alegn8) .Phadll.OflllllllllC
[CATFOUNDATION
Comments
Participation rate: 28%
Extema/ qua/ity Contra/ for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2015-1
Page 20 of 2012-May-2015Labeode: 9907152
RemarksSeveral participants reported a result below the deteclion limit «[value]). These resulls were nol included in lhestatislical evalualion.
[CATFOUNDATION
Comments
Participation rate: 33%
Extema! qua!ity Contra! for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2015-1
Page 18 of 2012-May-2015Labeode: 9907152
RemarksSeveral participants reported a result above the measurement range (> [value]). These results were not included in thestatistica! evaluation.
ECATFOUNDATION
Extemal qua/ity Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis
Survey: 2015-1
Page 16 of 2012-May-2015Labcode: 9907152
Commenls
Participalion rale: 35%
RemarksSeveral participanls reported a resull below lhe deleclion limil «[value]). These resulls were nol included in lheslalislical evalualion.
[CATFOUNDATION
Comments
Participation rate: 38%
Externa! qua/ity Contro! for Assays and TestsWith a foeus on Thrombosis and Haemostasis
Survey: 2015-1
Page 14 of 2012-May-2015Labeode: 9907152
RemarksSeveral participants reported a result above the measurement range (> [value]). These results were not included in thestatistical evaluation.
~ [CAT~ FOUNDATION
ILupus Anticoagulant
Extemal quality Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis
I IFinal Conclusion
Survey: 2015-1
Page 12 of 2012-May-2015Labeode: 9907152
Final ConclusionNegative SorderUne Positive No Concluslon Your Result
I Total 4 5 429 45 Positive
Comments
In total 438 participants gave a final conclusion. Forty-five participants (9%) gave no final conclusion.
The sampie used in this survey was plasma from a patient diagnosed with a strong Lupus Anticoagulant.From those participants who gave a final conclusion, 98% c1assified the sampie as positive.
=E C-A-T-- Extemal quality Contral (or Assays and Tests"G With a (oeus on Thrambosis and Haemostasis
FOUNDATION
Assays
'so
300
_2SOC,o02
1SO
CommentsAlmost all performed conlirmation tests were classilied as positive (96%).
Survey: 2015-1
Page 10012012-May-2015Labeode: 9907152
ATFOUNDATION
Extemal qua/ity Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2015-1
Page 8 012012-May-2015Labeode: 9907152
.Olhef • Siemens POlhromtin ~ • Siemens ActinFSL .0I1l8r
.I,L APTT SI" • SlagOlRocIle PTT LA • StagolRoche PTT • SlagolRoche
.IL HemoslL SynlhA$
• Siemens • ur" DIIIg• LL.dRWT sera"n
4()
,
'"
",ou
PRWT
5
25
3
10
10
", 20oU
.dRWT
.dAPTT
100
40
24()
200
c,o0120
Assays
CommentsAlmost all performed mixing tests were c1assilied as prolonged (>95%).
[(ATFOUNDATION
External quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2015-1
Page 6 of 2012-May-2015Labcode: 9907152
Ratio n Illslgned CV (%) rangevalue
panel 1 z-score panel 2 z.score panel 3 z~score
APTT 273 2.23 23.6 1.20 - 3.85I.L APTTSP 39 2.95 16.6 1.94 - 3.70I.L HemoslL SynlhAsil 22 2.11 9.7 1.78 - 2.70I.L MixCon 9 2.14 1.37 - 2.44Siemens Actin FSl 44 1.78 11.5 1.20-2.15Siemens Pathromtin SL 26 1.80 5.4 1.55.2.34StagoiRoche APTI-Kaolin 5 1.71 1.64.2.85SlagolRoche PTT 26 1.99 7.4 1.63 - 2.34Slago/Roche PTT LA 65 2.56 9.9 1.47.3.07Trinity 8iotech Automated APTI 8 1.95 1.63.2.14Trinity Biotech TriniClot APTI-HS 10 2.26 3.6 2.03.3.85dAPTT 14 2.57 9.4 1.66.3.39Stago/Roche PTT LA 10 2.59 7.3 2.13 - 2.83dPT 8 3.63 1.45 - 5.55dRVVT 381 2.47 8.4 1.22 - 4.08 2.17 .1.43 2.20 .1.29American Diagnostics DWtest 9 2.49 2.20.2.77I.L HemoslL dRVVT screen 94 2.44 9.0 1.91 .3.97I.L LAC screen 18 2.51 9.5 2.21 .4.08Life Diagnostics LA screen 17 2.37 14.0 1.73.3.00Precision Biologie LA check 16 3.15 8.7 2.32.3.61Siemens LA1 screen 141 2.48 6.2 1.74.3.20 2.17 -2.00Stago I Rache DRVVT screen 69 2.42 7.0 1.82.3.11Technoclone LA Scree" 7 2.31 1.87 - 2.49 2.20KCT 7 4.13 1.88 - 4.62SCT 72 3.56 12.9 2.60-7.11Haematex SACT Reagent 6 4.13 3.21 - 7.11I.L SCT screen 66 3.53 12.3 2.60.4.78
Assays DRWT28 '80
O,..r--•....""""""(O(O (0(0(0(0M'<tlD(oON'<tlD(OON'<tlD(oo)"':"':"':"':NNNNNMMMMMMv ,
20
"
eo
'20
,,,
~,c,oo 80
.Oll\ef .Sjemen!
.1.L .PnIC8101
.1,LdRVVTlICl"een
•..•..•..•...NNNNMMMMvvvV ,
20
c,oo
'0
.Otrw .Slemens Palhromlin~ .S;flmensAdm FSL
.tL APTT SP • St8ll~oehe PTTlA • Stllllu'RodIe PTT
.IL HemoslL Sl'fltllAS
.'''TI.dRWT.dAPTT
'0
80
120
'",~5 ,oo
CommentsAlmost all performed screening tests were classified as prolonged (>98%).
[CATFOUNDATION
ECAT Foundation
Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2015-1
Page 4 of 2012-May-2015Labeode: 9907152
Director: Cr. P. MeijerECAT OfficeP,O. Box 1072250 AC Voorscholen, The Nelherlandsp/1one +31(0) 713030910: fal( + 31jO) 713030919E-mail info@ecalnlWebsile: wwwecatnlVAT number: NLB02836872B01
Reglslralion number Wllh the Chamber 01 Commerce (KvK) Gouda: 41174102Aillha ususl conditions are applicable 10eil cur services
All rights reserved No part of !his report mey be reproduced, storad in a retrieval system, cr transmitted In sny form or by maans, electronic, mechanical photocopying, recording or olherwise, without priorpermission from the ECAT FoundalionAppendixes are an integral part of IM total report
r{ [CAT~ FOUNDATlON
External qua/ity Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis
Survey: 2015-1
Page 2 of 2012-May-2015Labeode: 9907152