ecat foundation - lkf-kiel.de · ..ecat foundation ilupus anticoagulant no. of responders 218...

ECAT FOUNDATIONExternal quality Control for Assays and Tests

With a focus on Thrombosis and Haemostasis

REPORT

SURVEY 2013-4Lupus AnticoagulantLabeode 9907152

Copyright @ 2013ECAT Foundation

FOUNDATION

I Lupus Anticoagulant

No. of Responders283

Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis

I I Screening

Survey: 2013-4

Page 3 of 1804-February-20 14Labcode: 9907152

Sampie NoSampie Details

Stability

Homogeneity

13.106Plasma positive for Lupus AnticoagulantUnits: RatioPrior Use: None

30-November-2014

2.5 %

Assay Normal Borderline Prolonged No Your resultClassification

Screening 1 Screening 2 Screening 3APTT 8 7 313 2dAPTT 0 0 20 0dPT 0 0 10 0dRVVT 2 1 398 9 Prolonged ProlongedKCT 1 0 14 1PNP 0 0 2 0SCT 0 0 59 2

Ratio n assigned CV ("Ia) rangevalue

panel 1 z-score panel 2 z-score panel 3 z-score

APTT 270 1.74 20.7 0.98 - 3.36I.L. APTT SP 38 1.92 20.1 1.23 - 2.45I.L. HemoslL SynthAsil 21 1.83 7.6 1.50 - 2.30I.L. MixCon 11 1.41 3.8 1.18 - 1.46Siemens Actin FSL 40 1.46 11.6 0.98 - 2.67Siemens Pathromtin SL 23 1.46 9.1 1.27-2.14Stago/Roche APTT-Kaolin 5 1.46 1.34 - 2.53Stago/Roche PTT 24 1.63 8.2 1.46-1.94Stago/Roche PTT LA 71 2.01 11.6 1.36-2.74Trinity Biotech Automated APTT 10 1.56 6.1 1.41-1.93Trinity Biotech TriniClot APTT-HS 8 1.84 1.58 - 3.05

dAPTT 16 2.17 18.5 1.66 - 4.17StagolRoche PTT LA 9 1.94 1.85 - 2.41

dPT 8 2.63 1.43 - 4.79Siemens Innovin 5 3.02 1.69 - 4.79

dRVVT 343 2.19 10.1 0.38 - 3.69 1.67 -2.33 1.75 -1.97American Diagnostics DWtest 12 2.28 10.0 2.05 - 2.90I.L. HemoslL dRWT screen 65 2.08 9.5 1.55 - 2.67I.L. LAC screen 30 2.15 7.6 1.77 - 3.69Life Diagnostics LA screen 19 2.31 13.2 0.38 - 2.88Precision Biologie LA check 16 2.56 7.1 2.24 - 2.95Siemens LA 1 screen 119 2.19 8.4 1.40 - 3.21 . 1.67 -2.82Stago / Roche DRWT screen 59 2.18 7.9 1.73 - 2.52Technoclone LA Screen 7 2.20 1.75 - 2.46 1.75KCT 12 2.81 51.4 0.30 - 5.33Homemade Kaolin 7 301 0.30 - 3.89SCT 56 2.76 20.9 1.91 - 6.70I.L. SCT screen 52 2.68 18.5 1.91 - 4.10

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

11 Mixing

Survey: 2013-4

Page 5 of 1804-February-2014Labeode: 9907152


Stability

Homogeneity


30-November-2014

2.5 %

Assay Normal Borderline Prolonged No Your resultClassification

Mixing 1 Mixing 2 Mixing 3APTT 24 18 211 2dAPTT 0 0 24 0dPT 1 1 4 0dRWT 9 3 221 4KCT 1 0 11 0PT 0 0 1 0SCT 1 1 30 0

Ratio n assigned CV (%) rangevalue


APTT 227 1.37 13.0 0.81-2.41I.L. APTT SP 26 1.42 7.3 1.21-1.68I.L. Hemosil SynthAFax 5 1.14 1.08 - 2.20I.L. HemoslL SynthAsil 16 1.44 7.3 1.30 -1.95I.L. MixCon 6 1.26 1.22 - 1.52Siemens Actin FSL 33 1.20 8.2 0.81 - 1.56Siemens Pathromtin SL 19 1.23 7.2 1.10 -1.47Stago/Roche PTT 19 1.31 6.6 1.10 - 1.52Stago/Roche PTT LA 72 1.48 8.8 0.98 - 1.98Trinity Biotech Automated APTT 10 1.22 10.9 0.84 - 1.47Trinity Biotech TriniClot APTT-HS 5 1.34 1.24 - 1.57dAPTT 23 1.62 23.4 1.18 - 3.63Stago/Roche PTT LA 9 1.47 1.34 - 2.09dPT 5 1.52 1.23 - 2.59dRWT 212 1.58 9.9 0.30 - 2.46American Diagnostics DWtest 6 1.65 1.29 - 2.08I.L. HemoslL dRVVT screen 27 1.56 9.2 1.26 - 2.15I.L. LAC screen 10 1.54 11.6 1.31-1.83Life Diagnostics LA screen 11 1.64 10.9 1.40 - 1.99Precision Biologie LA check 9 1.70 0.95 - 1.80Siemens LA1 screen 88 1.57 8.6 1.00-2.14Stago / Roche DRVVT screen 39 1.61 7.8 1.00 - 2.15KCT 10 2.45 32.1 0.38 - 3.91Homemade Kaolin 6 2.29 0.38 - 2.97SCT 29 1.99 15.9 1.29 - 2.99Haematex SACT Reagent 5 2.55 2.07 - 2.99I.L. SCT screen 23 1.93 12.0 1.47 - 2.50

..ECATFOUNDATION



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

I I Confirmation

Survey: 2013-4



Stability

Homogeneity

13.106Plasma positive for Lupus AnticoagulantUnits: RatioPrior Use: None30-November-2014

2.5 %

Assay Positive Borderline Negative No Your resultClassification

Confirm 1 Confirm 2 Confirm 3APTT 118 7 4 0dAPTT 14 0 2 0dPT 10 0 0 0dRWT 401 14 9 1 LA Positive LA PositiveKCT 1 0 0 0PNP 12 1 2 0PT 2 0 0 0SCT 56 0 1 0

Ratio n assigned CV (%) rangevalue


APTT 82 1.22 13.2 0.32 - 3.64I.L. Hemosil SynthAFax 13 1.14 4.9 1.07-1.26I.L. MixCon 12 1.19 16.8 1.02 - 1.58Siemens Actin FS 29 1.15 7.1 1.03 - 1.31Stago/Roche Staclot LA 12 1.42 22.6 0.32 - 3.02

dAPTT 8 1.19 1.03-1.76

dPT 7 1.28 1.20-3.40

dRWT 353 1.18 9.1 0.92 - 3.00 0.92 -2.42 1.01 -1.58American Diagnostics DWconfirm 13 1.29 12.6 1.11 - 1.73I.L. HemoslL dRVVT confirm 63 1.19 8.8 0.98 - 2.32I.L. LAC confirm 36 1.20 8.5 1.04-1.98Life Diagnostics LA confirm 17 1.15 6.9 0.99 - 1.44Precision Biologie LA sure 17 1.41 30.7 1.10 - 2.29Siemens LA2 confirmation 123 1.14 8.4 0.92 - 2.23 0.92 -2.34Stago/Roche DRVVT Confirm 62 1.18 8.3 1.02 - 3.00Technoclone LA Confirm 8 1.12 0.99 - 1.25 1.01

SCT 55 1.32 9.6 1.07 - 3.66I.L. SCT confirm 52 1.31 8.9 1.07 - 3.22

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

I Ratio Screening/Confirmation

Survey: 2013-4


Sam pie NoSam pie Details

Stability

Homogeneity


30-November-2014

2.5 %

Ratio Screening/Confirmation n assigned CV (%) rangevalue


APTT I 71 1.37 14.5 0.96 - 28.2CdAPTT I 7 1.94 1.00 - 4.21dRVVT 399 1.90 13.0 0.32 - 2.86 2.20 1.20 1.88 -0.09

SCT I 54 2.07 19.5 1.52 - 3.36

Assays

140

120

100

~ 80oU

60

40

20

O~~~~~~~MNN~~ommt"-OOON-qtOCOON-q-«)COO .•...NOO~~~~~NNNNNM""MV A

.OtherseT

,ECATFOUNDATION



Externa! quality Contra! for Assays and TestsWith a foeus on Thrambosis and Haemostasis

I IAntiCardiolipin Antibodies IgG

Survey: 2013-4


Sam pie NoSampie Details

Stability

Homogeneity

13.106Plasma positive for Lupus AnticoagulantUnits: GPL, IJg/mL, OtherPrior Use: None

30-November -2014

2.5 %

ClassificationNegative Borderline Low Positive Medium Positive High Positive No Conclusion

I Total 3 0 6 53 132 2

IgG n assigned CV (%)value

range Your result z-score

Total Group -GPl 155 76.3 36.7 2.0 - 1055.0Aeskulisa Diagnotic GmbH 5 296.2 36.0 - 300.0Bio-rad 6 160.0 58.6 - 160.0Corgenix REAADS 7 61.0 2.0 - 65.0Euroimmun 8 84.7 38.0 - 116.2INOVA Diagnostics Inc. 20 62.3 19.8 30.1 - 89.0Orgentec 17 68.2 39.2 2.0 - 117.0Orgentec (Alegria) 18 101.4 21.6 52.8 - 120.0Phadia 46 73.0 11.0 38.0 - 97.0Varelisa 5 54.0 33.8 - 100.0

IJglml 1 2.8 2.8 - 2.8Other 38 283.5 88.1 2.4 - 592.4Euroimmun 5 102.9 3.7 -113.0I.L. Acustar 13 526.2 11.0 427.3 - 592.4

40

'E 30::loCJ

20

10

o IONf'--T""" CDO lJ'>O>MCONf'--T"""(OCOv ~N .•....cnCOtO-.:t("') .•.... ocor---lJ)mcDmN...tr---:OMccimN~r---:c:icD..-C"1'o:tLOI'-COc:nONM'o:ttDID

.Other .INOVA

Orgenlec (Alegria) .Phadia

.Orgentec

r;., "Ee AT~ FOUNDATION



Externa! quality Contra! for Assays and TestsWith a foeus on Thrambosis and Haemostasis

I AntiCardiolipin Antibodies IgM

Survey: 2013-4

Page 13 of 1804-February-20 14Labeode: 9907152


Stability

Homogeneity

13.106Plasma positive for Lupus AnticoagulantUnits: MPL, flg/mL, OtherPrior Use: None30-November -2014

2.5 %


\ Total 143 7 15 1 3 3

IgM n assigned CV (%)value


Total Group -MPL 137 7.8 47.6 1.0-103.0Bio-rad 6 11.1 5.6 -12.0Corgenix REAADS 7 8.0 1.0-15.0Euroimmun 6 8.0 3.8 -10.6INOVA Diagnostics Inc. 18 15.3 20.5 8.0 -19.0Orgentec 16 6.6 23.1 4.4 - 9.3Orgentec (Alegria) 16 5.4 16.6 4.1 - 11.1Other 5 6.9 3.0 - 85.3Phadia 38 5.6 22.9 1.0 - 8.7

IJglmL 1 0.4 0.4 - 0.4Dther 34 9.5 35.2 0.5 - 44.0Euroimmun 5 9.8 0.8 - 11.3I.L. Acustar 12 10.7 12.4 5.6 - 12.6

35

-c:::loU 2

O~Mm~Nrovo~Mm~Nrowr---.<DM..--(J)(,O"l;f"Nmf".,..q-Not'--ID.....:N~cDr---:ai.....:M«:iIDcrioNM.q:v ..--..-,.....,....,....NNNN

".Other .'NOVAOrgentec (Alegria) .Phadia

.Orgentec

ECATFOUNDATION

Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis

Survey: 2013-4




I ß2-Glycoprotein I Antibodies IgG


Stability

Homogeneity

13.106Plasma positive for Lupus AnticoagulantUnits: U, IJg/mL, OtherPrior Use: None

30-November-2014

2.5 %


I Total 6 0 9 44 97 3

IgG n assigned CV (%)value


Ratio 24 6.0 96.5 0.1 - 132.0-

U 109 71.4 57.0 2.0 - 3310.0Aeskulisa Diagnotic GmbH 5 21.1 2.0 - 51.2Corgenix REAADS 7 110.0 2.0 - 150.7INOVA Diagnostics Inc. 15 37.5 31.9 7.0 - 62.0Orgentec 15 52.8 39.0 23.3 - 100.0Orgentec (Alegria) 13 52.2 75.1 14.7 - 100.0Phadia 35 91.0 9.4 49.0 - 106.0IJglmL 3 2.7 0.4-21.0Dther 46 848.6 165.0 2.9 - 2945.0Euroimmun 7 121.0 4.0 - 134.0I.L. Acustar 11 2824.1 5.2 2312.2 - 2945.0Phadia 6 88.4 79.0 - 100.0

24

20

16-<::'"oU 12

°OMCO("')cn~())""'OL()O<D"':-CDcnv ~~~~t'--:"":~~~~~~'"'"":c.o:

<DC»NLOCOr-"I:tI"--O"l:tI'--OM(J').•....("')...,.LOf'-..rocn .•....NMlOtOtO

.Other .INOVAOrgentec (Alegria) • Phadia

.Orgentec

FOUNDATION


Survey: 2013-4

Page17of1804-February-2014Labeode: 9907152

I Lupus Anticoagulant I ß2-Glycoprotein I Antibodies IgM


Sam pie NoSam pie Details

Stability

Homogeneity

13.106Plasma positive for Lupus AnticoagulantUnits: U, ~g/mL, OtherPrior Use: None

30-November-2014

2.5 %

ClassifieationNegative Borderline Low Positive Medium Positive High Positive No Conclusion

I Total 105 9 10 6 3 0

IgM n assigned CV (%)value

Your result z-seore

Ratio 21 1.3 63.6 0.4 - 20.0-

Seleet from list 4 6.5 5.5 - 7.7

U 88 7.1 50.6 0.0 - 75.3Aeskulisa Diagnotie GmbH 5 5.1 2.0 - 9.6Corgenix REAADS 6 15.8 11.0 - 20.0INOVA Diagnosties Ine. 13 9.9 33.4 0.0 -13.2

Orgentee 15 6.6 33.0 3.9 -10.0Orgentee (Alegria) 12 4.4 37.6 1.7 - 7.3Phadia 22 6.1 21.0 1.0 - 8.0

IJglmL 3 5.7 0.3 - 8.3

Dther 38 8.9 48.6 0.5 - 77.8Euroimmun 6 58.1 45.0 - 77.8

I.L. Aeustar 10 9.6 8.3 4.7-10.7Phadia 6 6.7 4.4 - 9.1

.Y.24

20

16 IC::l0U 12

°owm~~wm~MWOO~MWNv r---.NCOMCO("")C»'l:tC»~OL()OCOONMuitOo:im~N...tc.Or---:mol..-- ..- ..- ...-- ..-- ..-- ..--~

.Olher .'NOVAOrgenlec (Alegria) .Phadia

.Orgentec

.,ECATFOUNDATION

Comments

Participation rate: 33%

RemarksNone


Survey: 2013-4

Page 14 of 1804-F ebruary-20 14Labeode: 9907152

E C AT E~ternal quality Contral for Assays and TestsWtth a foeus on Thrambosis and Haemostasis

FOUNDATION

Comments


RemarksNone

Survey: 2013-4


I,ECATFOUNDATION


Survey: 2013-4


I Lupus Anticoagulant I I Final Conclusion

Final ConclusionNegative Borderline Positive Your Result

I Total 2 9 408 Positive

Comments

In total 419 participants gave a final conclusion. Thirty-three participants (7%) gave no final conclusion.

The sampie used in this survey was plasma fram a patient positively diagnosed for Lupus Anticoagulant.From those participants that gave a final conclusion, 97% c1assified the sampie as positive.

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

Survey: 2013-4

Page 8 of 1804-F ebruary-2014Labeode: 9907152

Assays350

300

250

°OO~NMv~~ID~romo~~V..-("')lOI"--O>..-(,,)IOI"---(J)..--c:t(Of'-..

ocioOO~"":"":"":"":NNNN ~

50

10

~ 20oU

.Other

seT

CommentsApproximately 94% of the performed confirmation tests were c1assified as positive, 3% as borderline and 3% asnegative.

~- "ECAT" FOUNDATION


Survey: 2013-4

Page 6 of 1804-F ebruary-20 14Labeode: 9907152

-..-vMN..--OO>COr---C.DLOvMNI'-v ~'"'-:~'?~~~~r---:ce:~~'"'-:""":..-..--.•......•.....--..--..--..--..-..-..-NNN ~

°N<D~NO(X)<DV('l')..--O>l"--l.O('I')~~~~~~-r-:~'?~~~~!':ce:~000..--...--..-..-..- .•......--.•.....--..--..--..--v ~

10

°mI'-VO<DMO>l.ONOOL{)..--r---'l:tNON(()OM('-..O-.;tCO..--iJ)(J)NCDCO666"--:"--:"":NNNMev>M-.i-.i-.iv ~

Assays APTT DRWT280 50

240 35

4030

20 --g 16•.. 25 ;: 3'":l :l

0 0 0(J (J 20 (J

12020

15

8010

.OtherAPTI

.dRVVT

dAPTI

.Other • SiemensPathromtin~ • SiemensActinFSL .Other1.L.APTI SP • SlagoiRoche PD LA I.L.

.StagolRoche PD

.Siemens• SlagolRoche

.life Diag

.I.L. dRVVTscreen

CommentsAlso for the mixing tests the vast majority of the performed tests was classified as prolonged (82%). Six percent wasc1assified as borderline and 10% as normal. The normal c1assifications were mostly based on an APTT-based assay(67%).

~"\ECAT.. ~ FOUNDATION

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

Survey: 2013-4

Page 4 of 1804-February-2014Labcode: 9907152

VI"--.,..-lO<J:IMI"--..--(OOVCONCOM"....:~~l"--:~~~'?~~l"--:~~~~v "-"--..--..--NNNNNNNMMM

A

°CD~~,..-COCDVNOCOCDM,..-(j)CO1':~~~'?U?r--:~'"'"-:~~~~~~oO..--..--...--..--.•.....•...NNNNNNMv A

•°O~N~N~N~~~~~~~M

V NCOM(j)..qOIO~CDN"""'C")CO,..-6ci"....:"....:NMM,..f~LriLOcD<Or'A

Assays APTT DRWT32 60 100

28050 -I40 ••..

~ 6<:::l ::l0 0U 30 U

20 I10

.OtherAPTI

.dRVVT

dAPTI.Other

LL.APTI SP• StagolRoche PTI

.Siemens Pathromtin~.SiemensAetin FSL .OtherliIStagcWRoche pn LA Life Diag

• SlagQIRoche

.SiemensIIIPrec Biol

CommentsThe vast majority of the performed screening tests was c1assified as prolonged (96%).

"ECATFOUNDATION

External quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis

Survey: 2013-4

Page 2 of 1804-February-2014Labcode: 9907152

Date of Issue

Survey

Report

04-February-2014

2013-4

Lupus Anticoagulant

Note:In the Survey Manual 2013 detailed information is given regarding the ECAT external quality assessment programme,including the statisticai evaluation and explanation of the report.This Survey Manual 2013 should be considered as an integral part of this survey report.

General Information

Currently there are 515 participants registered for the Lupus Anticoagulant module. In totally 452 participants havesubmitted results. The response rate is 88% .

..•.....

P.MeijerExecutive Director

Note: A printed version of the Survey Manual 2013 is provided to all participants once a year. This manual can also bedown loaded fram the member section of the ECAT website.

ECAT Foundalion

Director: Dr. P. MeijerECAT OfficePO. Box 1072250 AC Voorschoten, The Netherlandsphone +31 (0) 71 3030 910 fax + 31 (0) 713030 919E-mail: info@ecatnlWebsite www.ecatnlVAT number: N L802836872B01

Registration number with the Chamber of Commerce (KvK) Gouda 41174102All the usual conditions are applicable to all aur services

All rights reserved. No part of this rsport may be reproduced. stored in a retrieval system cr transmitted in any form er by means. electronic, mechanical, photocopying. recording cr otherwise, without priorpermission fram the ECAl Foundation.Appendixes are an integral part of the total rsport

http://www.ecatnl

~., .,ECAT. ~ FOUNDATION

Comments


RemarksNone

External quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis

Survey: 2013-4


'~~.,ECAT" FOUNDATION

Comments


RemarksNone


Survey: 2013-4


ecat foundation - lkf-kiel.de · ..ecat foundation ilupus anticoagulant no. of responders 218...

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