ECAT FOUNDATION REPORT

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1 ECAT External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis REPORT SURVEY lupus Anticoagulant labeode ECAT Foundation

2 FOUNDATlON External qua/ity Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis Page 30f20 Date of Issue Survey Report 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 have submilted results. The response rate is 90%. P.Meijer Executive Director Note: A printed version of the actual Survey Manual is provided to all participants down loaded from the member section of the ECAT website. once a year. This manual can also be

3 Externa/ qua/ity Contro/ for Assays and Tests With a foeus on Thrombosis and Haemostasis Page Labcode: ILupus Anticoagulant I IScreening No. of Responders 304 Sampie Sampie Stability No Details Plasma strongly positive lor Lupus Anticoagulant Units: Ratio Prior Use: None 31-January-2017 Homogeneily 2.1 % Assay Normal Borderline Prolonged No Your result Classification APTT daptt Screening 1 Screening 2 Screening 3 dpt drvvt Prolonged Prolonged KCT Other PNP PT SCT

4 External qua/ity Control for Assays and Tests With a foeus on Thrombosis and Haemostasis Page 7 of 20 Labcode: I Lupus Anticoagulant No. of Responders Mixing Sampie Sampie No Details Plasma strongly positive for Lupus Anticoagulant Units: Ralio Prior Use: None Stability Homogeneity 31-January % Assay Normal Borderline Prolonged No Your resull Classification APTT daptt dpt drvvt KCT Olher PNP PT SCT Mixing 1 Mixing 2 Mixing 3 Ratio n 81!lsignedCV (%) range value panel 1 z-score panel 2 z-score panel 3 z-score APTT I.L. APTT SP I.L. HemoslL SynthAsil I.L. Mixeon Siemens Actin FSl Siemens Pathromtin SL Stago/Roche PTT Slago/Roche PTT LA Trinity Biotech Automated APTT Trinity 8iotech TriniClot APTI-HS daptt Stago/Roche PTT LA drwt American Diagnostics DWtest I.L. HemoslL drwt screen Life Diagnostics LA screen Precision Biologie LA check Siemens LA1 screen Siemens la2 confirmation tago I Rache DRWT screen KCT SCT Haematex SACT Reagent I.L. SeT screen

5 Extemal qua/ity Control for Assays and Tests With a foeus on Thrombosis and Haemostasis Page I Lupus Anticoagulant I IConfirmation No. 01 Responders 239 Sampie Sampie Stabilily No Details Plasma strongly positive lor Lupus Antieoagulant Units: Ratio Prior Use: None 31-January-2017 Homogeneily 2.1 % Assay Positive Borderline Negative No Your result Classilieation APTT daptt Confirm 1 Confirm 2 Confirm 3 dpt drvvt LA Positive LA Positive KCT Other PNP PT SCT Ratio n ISligned CV (%) range value panel 1 z-score panel 2 z-score panel 3 z.score APTT L. Hemosil SynthAFax I.L. Mixeon Siemens Actin FS Sta9o/Roche Slaclot LA Technoclone Lupus Anticoagulant Test daptt dpt drwt American Diagnostics DWconfirm I.L. HemoslL drvvt confirm I.L LAC confirm Life Diagnostics LA confirm Precision Biologie LA sure Siemens la2 confirmation StagoiRoche DRWT Confirm Technoclone LA Confirm PNP SeT I.L set confirm

6 ECAT External quality Control {ar Assays and Tests With a {oeus on Thrombosis and Haemostasis Page I Lupus Anticoagulant No. of Responders 483 I Ratio Screening/Confinnation Sam pie No Sampie Details Stability Homogeneity Plasma strongly positive lor Lupus Anticoagulant Units: Ratio Prior Use: None 31-January % Ratio Screening/Confirmation n IIsslgned CV (%) range Yldue panel 1 z-score panel 2 z.score panel 3 z-score APTT daptt I drvvt SeT I Assays '80 180, c () '",

7 Extemal quality Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis Page I Lupus Anticoagulant No. of Responders 206 I AntiCardiolipin Antibodies IgG Sampie Sampie No Details Plasma strongly positive lor Lupus Anticoagulant Units: GPL, ~g/ml, Other Prior Use: None Stabilily Homogeneily 31-January % Classification Negative Borderllne Low Positive MedIum Positive High Positive No Conc1usion I Total IgG n Blllligned CV (%) value range Your result z-score 'fatal Group, -. ",," GPL Corgenix REAADS Euroimmun INOVA Diagnostics lnc Orgentec Orgentec (Alegria) Phadia , ~g1ml Other I.L. Acustar " 20 " ", o 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)N v....- NNNA.Otller.INOVA.Orgentec.Phadll

8 FOUNDATlON External qua/ity Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis Page I Lupus Anticoagulant I AntiCardiolipin Antibodies IgM No. of Responders 186 Sampie Sampie Stability No Details Plasma strongly positive lor Lupus Anticoagulanl Units: MPL, IJg/mL, Other Prior Use: None 31-January-2017 Homogeneity 2.1 % Classification Negative Bordertine Low Positive Medium Positive High Positive No Conclusion I Total IgM n asalgned CV (%) value itöläl GroUIl - MPL Aeskulisa Diagnotic GmbH Bio-rad Corgenix REAADS Euroimmun INOVA Diagnostics Ine Orgentec Orgentec (Alegria) Phadia ~glml Other I.L. Acustar range Your result z-score 70 c, o u.00"".orgllnlec.eurolmmun.inova Oroenlec (Aleoria) Phadia

9 Extemal quality Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis Page 17 of 20 I Lupus Anticoagulant Iß2-Glycoprotein I Antibodies IgG No. of Responders 175 Sam pie No Sam pie Details Stability Homogeneity Plasma strongly positive for Lupus Anticoagulant Units: U, ~g/ml, Other Prior Use: None 31.January % Classification Negative Borderline Low Positive Medium Positive High Positive No Conclusion I Tolal IgG n BSligned CV (%) value range Your result z-score Ratio U Aeskulisa Diagnotic GmbH Corgenix REAADS INOVA Diagnostics Inc Orgentec Phadia ~glml Qther Euroimmun I.L. Acustar y. 14 C 10, o U 8 8

10 c, o U 12 [(AT Extemal qua/ity Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis Page 19 of 20 I Lupus Anticoagulant I ß2-Glycoprotein I Antibodies IgM No. of Responders 149 Sampie No Sampie Details Stability Homogeneity Plasma strongly positive for Lupus Anticoagulant Units: U, IJg/mL, Other Prior Use: None 31-January % Classlficatlon Negative Borderllne low Positive Medium PosItive HIgh Positive No Concluslon I Total IgM n lisalgned CV (%) vatue Ratio Seleet trom list U Aeskulisa Diagnotic GmbH Corgenix REAADS INOVA Diagnostics Inc Orgentec Orgentec (Alegria) Phadia ~glml Other Euroimmun I.L. Acustar Your re5uft z-score " 4.Olller.INOVA.OfvenlllC(Alegn8).Phadll.OflllllllllC

11 Extema/ qua/ity Contra/ for Assays and Tests With a foeus on Thrambosis and Haemostasis Page 20 of 20 Comments Participation rate: 28% Remarks Several participants reported a result below the deteclion limit «[value]). These resulls were nol included in lhe statislical evalualion.

12 Extema! qua!ity Contra! for Assays and Tests With a foeus on Thrambosis and Haemostasis Page 18 of 20 Comments Participation rate: 33% Remarks Several participants reported a result above the measurement range (> [value]). These results were not included in the statistica! evaluation.

13 ECAT Extemal qua/ity Control for Assays and Tests With a foeus on Thrombosis and Haemostasis Page 16 of 20 Labcode: Commenls Participalion rale: 35% Remarks Several participanls reported a resull below lhe deleclion limil «[value]). These resulls were nol included in lhe slalislical evalualion.

14 Externa! qua/ity Contro! for Assays and Tests With a foeus on Thrombosis and Haemostasis Page 14 of 20 Comments Participation rate: 38% Remarks Several participants reported a result above the measurement range (> [value]). These results were not included in the statistical evaluation.

15 ~ [CAT ~ Extemal quality Control for Assays and Tests With a foeus on Thrombosis and Haemostasis Page 12 of 20 I Lupus Anticoagulant I IFinal Conclusion Final Conclusion Negative SorderUne Positive No Concluslon Your Result I Total 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.

16 =E C-A-T- - Extemal quality Contral (or Assays and Tests "G With a (oeus on Thrambosis and Haemostasis Page Assays 'so 300 _2SO C, o 02 1SO Comments Almost all performed conlirmation tests were classilied as positive (96%).

17 AT Extemal qua/ity Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis Page Assays 24() 3 PRWT, c,o ", o U 10 ", o u '" 4() dRWT.dAPTT.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 Comments Almost all performed mixing tests were c1assilied as prolonged (>95%).

18 [(AT External quality Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis Page 6 of 20 Labcode: Ratio n Illslgned CV (%) range value panel 1 z-score panel 2 z.score panel 3 z~score APTT I.L APTTSP I.L HemoslL SynlhAsil I.L MixCon Siemens Actin FSl Siemens Pathromtin SL StagoiRoche APTI-Kaolin SlagolRoche PTT Slago/Roche PTT LA Trinity 8iotech Automated APTI Trinity Biotech TriniClot APTI-HS daptt Stago/Roche PTT LA dpt drvvt American Diagnostics DWtest I.L HemoslL drvvt screen I.L LAC screen Life Diagnostics LA screen Precision Biologie LA check Siemens LA1 screen Stago I Rache DRVVT screen Technoclone LA Scree" KCT SCT Haematex SACT Reagent I.L SCT screen Assays 28 ~ 5, o '", 120 c, o DRWT '80,,, '20 ~, c, o 80 eo 80 '0 20 '0 " 20.dRWT.dAPTT.'''TI NNNNMMMMvvv V,.Otrw.Slemens Palhromlin~.S;flmensAdm FSL.tL APTT SP St8ll~oehe PTTlA Stllllu'RodIe PTT.IL HemoslL Sl'fltllAS O,..r--... """"""(O(O (0(0(0(0 M'<tlD(oON'<tlD(OON'<tlD(oo) "':"':"':"':NNNNNMMMMMM v,.oll\ef.1.l.1,ldrvvtlicl"een.sjemen!.pnic8101 Comments Almost all performed screening tests were classified as prolonged (>98%).

19 Extemal quality Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis Page 4 of 20 ECAT Foundation Director: Cr. P. Meijer ECAT Office P,O. Box AC Voorscholen, The Nelherlands p/1one +31(0) : fal( + 31jO) info@ecalnl Websile: wwwecatnl VAT number: NLB B01 Reglslralion number Wllh the Chamber 01 Commerce (KvK) Gouda: Aillha 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 prior permission from the ECAT Foundalion Appendixes are an integral part of IM total report

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