ECAT FOUNDATION REPORT

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1 ECAT FOUNDATION With a focus on Thrombosis and Haemostasis REPORT SURVEY Main Labcode Copyright 206 ECAT Foundation

2 FOUNDATION Ar, With a focus on Thrombosis and Haemostasis Page 3 of Fit7rinolysis II PAI- antigen. of Responders 33 Sample 6.0 Sample Details Coagulation Control Plasma Units: ng/ml Prior Use: ne 3-Dec-207 Homogeneity.6 % Homogeneity Parameter APTT Response Rate 49 % ab Ab Total 2 9 n assigned CV (%) range your z-score result Total Group Homemade 23. Hyphen Biomed Elitest PAI- antigen Hyphen Biomed Zynnutest PAI- antigen Other 24.0 Stago Asserachrom PAI Tcoag TriniLIZE PAI- antigen Technoclone Technozym PA- antigen e CD N- e th r- de 6 ä 05 Co c i N N CO CO CO 'I', A EIA

3 EC A T i r FOUNDATION Fibrinolysis II With a focus on Thrombosis and Haemostasis PAI- antigen Page 5 of Z-score plot Z-score history r I i, 4-3 A 2 2 esse - H I, i r r i Your result -4 2 CO.7` c Z-score sample CN Comments Sample 6.0 ne Sample 6. One participant reported a result below the detection limit (I]). This result was excluded in the statistical evaluation.

4 ee, A rr With a focus on Thrombosis and Haemostasis FOUNDATION Page 7 of Fibrinolysis II PAI- activity Sample 6. Sample Details Ab Coagulation Control Plasma Units: IU/mL Prior Use: ne 3-Dec-207 Homogeneity 2.0 % Homogeneity Parameter APTT Response Rate 44 `)/0 ab Ab Total n assigned CV (%) range your z-score result Chromogenic Other 3.6 Sekisui Spectrolyse PAI- 5.6 Siemens Berichrom PAI Stago Stachrom PAI BIA/ELISA Homemade 0.0 Hyphen Biomed Zymutest PAI- activity Technoclone Technozym PAI- activity ther III c5 co it! cy cy ob ch v ä <- csi e5 ei u5 --: 05 o5 oi A ,

5 eecat FOUNDATION VVith a focus on Thrombosis and Haemostasis Page 9 of Fibrinolysts II. of Responders 24 t-pa antigen Sample 6.0 Sample Details Coagulation Control Plasma Units: ng/ml Prior Use: ne 3-Dec-207 Homogeneity.6 % Homogeneity Parameter APTT Response Rate 35 A ab Ab Total n assigned CV (%) range Hyphen Biomed Zymutest t-pa antigen Other 0.0 Stago Asserachrom t-pa Technoclone Technozym t-pa antigen your z-score result o cb cb!ckl rzv 4, tri c i N: cri ci N N EIA

6 t,,eca 64' f r FOUNDATION Extemal quality Control for Assays and Tests th a focus on Thrombosis and Haemostasis w Page of Fibrinolysis II t-pa antigen Z-score plot Z-score history J o 0!., -2 El Your result Z-score sample -4 Comments Sample 6.0 ne Sample 6. Two participants reported a result below the detection limit (I]). These results were excluded in the statistical evaluation.

7 Ec A,r Exitheranafol cq usaloityn CThornotmrobl foosrisaas nsadyiim s aend otsetsatsis -r Mai, FOUNDATION Page 0 of Fibriillysis II t-pa antigen Sample 6. Sample Details Ab Coagulation Control Plasma Units: ng/ml Prior Use: ne 3-Dec-207 Homogeneity 2.0 % Homogeneity Parameter APTT Response Rate 35 % ab Ab Total n assigned CV (%) range Total Group Hyphen Biomed Zymutest t-pa antigen Other.0 Stago Asserachrom t-pa Technoclone Technozym t-pa antigen your z-score result c cie I lir ä v ci ci ei ei dddidd EIA

8 reec AT With a focus on Thrombosis and Haemostasis FOUNDATION Page 8 of Fibrinolysis II PAI- activity Z-score plot Z-score history i 2 Z-score sample 2,- - rzi r- Your result (il Cr) Z-score sampie o_-_ 5 CN CN Comments Six participants reported their results of PAI- activity in ng/ml. These results were excluded in the statistical evaluation. The results are: Labcode Sample 6.0 Sample < Sample 6.0 Some participants reported a result below the detection limit (I]). These results were excluded in the statistical evaluation. Sample 6. Some participants reported a result below the detection limit (<[]). These results were excluded in the statistical evaluation.

9 Ec AT FOUNDATION With a focus on Thrombosis and Haemostasis Page 6 of kibrinolysis II. of Responders 30 PAI- activity Sample 6.0 Sample Details Coagulation Control Plasma Units: IU/mL Prior Use: ne 3-Dec-207 Hornogeneity.6 % Homogeneity Parameter APTT Response Rate 44 `)/0 ab Ab Total n assigned CV (%) range your z-score resu lt Total Group Chromogenic Other 5.0 Sekisui Spectrolyse PAI Siemens Berichrom PAI Stago Stachrom PAI BIA/ELISA Homemade 7.4 Hyphen Biomed Zymutest PAI- activity Tcoag TriniLIZE PAI- activity 8. Technoclone Technozym PAI- activity , ! cb 6 ei cci ei BChromogenic BBIA/ELISA A

10 T External -eec A ''- FOUNDATION quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis Page 4 of Fibrinolysis II AI- n e Sample 6. Sample Details Ab Coagulation Control Plasma Units: ng/ml Prior Use: ne 3-Dec-207 Homogeneity 2.0 % Homogeneity Parameter APTT Response Rate 49 % ab Ab Total n assigned CV (%) range your z-score result Total Group Homemade 6.6 Hyphen Biomed Elitest PAI- antigen Hyphen Biomed Zymutest PAI- antigen Other 7.0 Stago Asserachrom PAI Tcoag TriniLIZE PAI- antigen Technoclone Technozym PAI- antigen co CO N CY) C ai N N A EIA

11 ,,,, r_cat 7 WI L With a focus on Thrombosis and Haemostasis ' -- _ FOUNDATION Page 2 of Date of Issue : Survey : Report : Main te: In the Survey Manual 206 detailed information is given regarding the ECAT external quality assessment programme, including the statistical evaluation and explanation of the report. This Survey Manual 206 should be considered as an integral part of this survey report. General Information Currently approximately 500 laboratories participate in at least one of the modules of the ECAT External Quality Assesment Programme. Below a list is given of the number of participants of those modules included in the main report. Thrombophilia : 368 Fibrinolysis Module I : 37 UFH (anti-xa) : 32 Coagulation Factor Module I : 26 Fibrinolysis Module II : 68 LMWH (anti-xa) : 248 Coagulation Factor Module II : 222 Factor VIII Inhibitor : 283 Orgaran : 5 Von Willebrand Factor Module : 32 Factor IX Inhibitor : 68 Fondaparinux : 3 ADAMTS3 activity/antigen : 98 Homocysteine : 63 Rivaroxaban : 228 ADAMTS3 inhibitor : 73 Apixaban : 67 Factor XIII : 44 Argatroban : 45 Dabigatran : 98 The modules included in your report depend on your subscription profile. Complaints Any complaints regarding this survey report should be reported to the ECAT before December 9th, 206. Complaints received after this date will not be taken into consideration. P.Meijer Executive Director te: A printed version of the actual Survey Manual is provided to all participants once a year. This manual can also be downloaded from the member section of the ECAT website. ECAT Foundation Director: Dr. P. Meijer ECAT Office P.O. Box AC Voorschoten, The Netherlands phone +3(0) ; fax + 3(0) info@ecat.n Website: VAT number, NL Registration number with the Chamber of Commerce (KyK) Gouda : General terms of delivery are applicable to all our services. All rights reserved. part of this report may be reproduced, stored in a retrieval system, or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from the ECAT Foundation. Appendices are an integral part of the total report.

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