ECAT FOUNDATIONExternal quality Control for Assays and Tests

With a focus on Thrombosis and Haemostasis

REPORT

SURVEY 2015-4Main

Labeode 9907152

Copyright @ 2015ECAT Foundation

t),! E(AT'-~ FOUNDATION

Extemal quality Contral (or Assays and TestsWith a (oeus on Thrambosis and Haemostasis

Survey: 2015-4

Page 3 of 510-februari-2016Labeode: 9907152

1 Factor VIII inhibitor 11 Factor VIII Inhibitor

No. of Responders236

Sampie NoSampie Details

Stability

Homogeneity

Response Rate

15.152Plasma with a Factor VIII inhibtor level of 4 - 6 BU/mLUnits: BU/mLPrior Use: None

28-feb-2017

5.7 %85%

n asslgned CV (%) rangevalue

your z-scoreresult 90

.Homemade (B)

°010 N..,.,...O lI'ICO .•.•• M(Ov d~M'<iIrir--:o:iaig~~;!~~ ,

30

4.

20,.

.H<Jmomade(NB) .Comrn (NB)

.Comm (a) .UMkl'lOWll

~, 90o"

;rQlä[Group. 23 .3~ ~30.9 2.2 - 20.3 3.6 .1.40Home-made (non-buffered) 14 6.6 28.1 4.0 - 8.8Buffer 10 6.5 30.4 4.0 - 8.8Factor VIII Deficient Plasma 3 6.2 6.0 - 8.8Unknown 1 8.6

Commerclal (non-buffered) 47 6.6 37.8 2.5 - 20.3Buffer 29 6.7 37.0 2.5.19.5FaclorVll1 Deficient Plasma 10 6.2 40.5 3.3.20.3Heat-activated normal plasma 1 9.6Unknown 7 5.6 3.0-11.2Home-made (buffered) 29 6.2 31.4 2.2 - 17.0 3.6 -1.34Buffer 3 5.3 5.2 - 7.0Buffer + Albumin 2 6.4 5.0 - 7.8Factor VIII Deficient Plasma 17 6.8 31.7 4.1-17.0Heat-activated normal plasma 2 4.2 2.2 - 6.2Unknown 5 4.6 3.6 - 8.0 3.6Commerclal (bultered) 136 6.2 28.9 2.7 - 16.4Buffer 68 6.4 26.8 2.7-13.9Buffer + Albumin 7 5.0 3.4 - 8.0Factor VIII Deficient Plasma 38 5.9 29.6 3.0 - 13.4Heat-activated normal plasma 8 9.0 4.5 - 16.4Unknown 15 6.2 26.0 4.0 -12.0

Unknown 5 6.4 3.8.10.0Buffer 2 6.2 6.1 -6.4Unknown 3 6.5 3.8.10.0

tt~ECAT~ FOUNDATION

IFactor VIII inhibitorZ-score plot

Extema/ qua/ity Contra/ for Assays and TestsWith a foeus on Thrambosis and Haemostasis

11 Factor VIII Inhibitor

Z-score history

Survey: 2015-4

Page 5 of 510-februari-2016Labeode: 9907152

4

'""iiEcu"'~ou'l'N

• Your resull

4

3 ----------------------

2 ----------------------

1 -------.- •• -------------------------------------------~ou 0'l'N

-1 -- ---;----------:+:---------- .------ ---.-7>-----~ ----------------------~ ----------------------

Comments

402

Z-score sampie 1

4

-4N

••~oN

"i<CloN

'f<Cl~oN

One participant (labeode 249) reported results in optical densily (00).Theresults for sampies 15.152 and 15.153 were 1.390 and 1.040, respectively.These results were not included in the statistical evaluation.One participant (labeode 3167) reported for both sampies a result < 0.2BU/mL. These results were not included in the statistical evaluation.One participant reported only a result for sampie 15.152 and threeparticipants reported only a result for sampie 15.153.

Sampie 15.152The parameter for the testing homogeneily is: FVIII inhibitor

Sam pie 15.153The parameter for the testing homogeneily is: FVIII inhibitor

1~E(AT, -" FOUNDATION

1 Factor VIII inhibitor

Externa/ qua/ity Contra/ for Assays and TestsWith a foeus on Thrambosis and Haemostasis

11 Factor VIII Inhibitor

Survey: 2015-4

Page 4 of 510-februari-2016Labcode: 9907152

Sampie NoSampie Details

Stability

Homogeneity

Response Rate

15.153Plasma with a Factor VIII inhibtor level of 2 - 3 BU/mLUnits: BU/mLPrior Use: None28-feb-2017

7.9%85%

n assigned CV (%) rangevalue

your z.scoreresult eo

Total Group 233 3.1 32.9 1.4-16.1 1.8 -1.30Home-made (non-buffered) 14 3.3 28.2 2.0 - 4.5Sufter 10 3.2 27.5 2.0 - 4.5Fador VIII Deficient Plasma 3 4.0 3.2 - 4.4Unknown 1 2.1Commercial (non-butfered) 49 3.1 39.3 1.6-16.1Bufter 30 3.3 39.1 1.6 - 8.2FactorVll1 Deficient Plasma 10 2.9 38.7 1.7 -16.1Heat~activatednormal plasma 1 5.2Unknown 8 2.5 1.6.4.4Home-made (buffered) 29 3.1 30.0 1.7.6.6 I 1.8 -1.40Bufter 3 2.7 2.4 .5.0Bufter + Albumin 2 3.1 2.3 - 3.9Factor VIII Deficient Plasma 17 3.2 28.0 2.1 - 6.6Heat.activated normal plasma 2 3.4 3.0 - 3.9Unknown 5 2.5 1.7-3.8 1.8Commercial (buffered) 136 3.1 31.3 1.5 - 7.2Bufter 68 3.2 30.1 1.6 - 6.2Bufter + Albumin 7 2.8 1.6 - 3.7Faetor VIII Deficient Plasma 37 3.0 31.8 1.5 - 4.9Heat.activated normal plasma 8 4.2 2.0 - 6.1Unknown 16 3.0 31.6 1.7-7.2Unknown 5 3.5 1.4 - 5.5Bufter 2 3.0 2.4 - 3.5Unknown 3 5.3 1.4.5.5

7

eo

~ 50c,8 40

30

20

o

.Homemade(NB} .Comm. (NB)

.Comrn (B) .Unknown• Homemade (B)

~ [CAT, ~ FOUNDATION

Extemal quality Contral 'ar Assays and TestsWith a 'oeus on Thrambosis and Haemostasis

Survey: 2015-4

Page 2 of 510-februari-2016Labeode: 9907152

Date of Issue 10-februari-2016

Survey 2015-4

Report Main

Note:In the Survey Manual 2015 detailed information is given regarding the ECAT external qualily 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.

Generai Information

Currently approximately 1500 laboratories participate in at least one of lhe modules of the ECAT External Quality Assesment Programme.Belowa list is given of the number of participants of those modules included in the main report.

11521610410320112642182

UFH (ant~Xa)LMWH (ant~Xa)OrgaranFondaparinuxRivaroxabanApixabanArgatrobanDabigatran

1346527715665

Fibrinolysis Module IFibrinolysis Module 11Factor VIII InhibitorFactor IX InhibitorHomocysteine

35225621730710374140

ThrombophiliaCoagulalion Factor Module ICoagulalion Factor Module 11Von Willebrand Factor ModuleADAMTS13 aclivity/antlgenADAMTS13 inhibitorFactor XIII

The modules included in your report depend on your subscription profile.

For the first time the parameter used for the assessment of the homogeneity is indicated in the report.

ComplaintsAny complaints regarding this survey report should be reported to the ECAT before March 16th, 2016.Complaints received after this date will not be processed anymore.

Registration numberwilh the Chamber of Commerca (KvK) Gouda; 41174102All !he usus] oonditions are applicable 10 811aur services

11rights reserved No part of thls rapert may be reproduced. stored in aretrioval system or transmitted In any form or by means, electronic, roochanical photocopying. recording or oth8lWise, without priorrrnission lrom tha ECAT Foundatlonppendi~es are an integral part of tha total rapart

DIrector: Cr, P. MeijerECATOfficepo Box 1072250 AC Voorschole" The Nelherlandsphone "31(0) 713030910: fax + 31(0) 713030919E-mait il'lfo@ecatnl

ebsita wwwecat.nlAT number. NL602636872B01

ECAT Foundation

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 seelion of the ECAT website.