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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
FOUNDATION
I Lupus Anticoagulant
No. of Responders189
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
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
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
panel 1 z-score panel 2 z-score panel 3 z-score
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
I Lupus Anticoagulant
No. of Responders218
Externa/ qua/ity Contra/ for Assays and TestsWith a foeus on Thrambosis and Haemostasis
I I Confirmation
Survey: 2013-4
Page 7 of 1804-February-2014Labeode: 9907152
Sampie NoSampie Details
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
panel 1 z-score panel 2 z-score panel 3 z-score
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
FOUNDATION
I Lupus Anticoagulant
No. of Responders419
Extema! qua!ity Contra! for Assays and TestsWith a foeus on Thrambosis and Haemostasis
I Ratio Screening/Confirmation
Survey: 2013-4
Page 9 of 1804-February-2014Labeode: 9907152
Sam pie NoSam pie Details
Stability
Homogeneity
13.106Plasma positive for Lupus AnticoagulantUnits: RatioPrior Use: None
30-November-2014
2.5 %
Ratio Screening/Confirmation n assigned CV (%) rangevalue
panel 1 z-score panel 2 z-score panel 3 z-score
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
I Lupus Anticoagulant
No. of Responders196
Externa! quality Contra! for Assays and TestsWith a foeus on Thrambosis and Haemostasis
I IAntiCardiolipin Antibodies IgG
Survey: 2013-4
Page 11 of 1804-February-2014Labeode: 9907152
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
I Lupus Anticoagulant
No. of Responders172
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
Sampie NoSampie Details
Stability
Homogeneity
13.106Plasma positive for Lupus AnticoagulantUnits: MPL, flg/mL, OtherPrior Use: None30-November -2014
2.5 %
ClassificationNegative Borderline Low Positive Medium Positive High Positive No Conclusion
\ Total 143 7 15 1 3 3
IgM n assigned CV (%)value
range Your result z-score
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
Page 15 of 1804-February-20 14Labeode: 9907152
I Lupus Anticoagulant
No. of Responders159
I ß2-Glycoprotein I Antibodies IgG
Sampie NoSampie Details
Stability
Homogeneity
13.106Plasma positive for Lupus AnticoagulantUnits: U, IJg/mL, OtherPrior Use: None
30-November-2014
2.5 %
ClassificationNegative Borderline Low Positive Medium Positive High Positive No Conclusion
I Total 6 0 9 44 97 3
IgG n assigned CV (%)value
range Your result z-score
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
Externa! qua!ity Contra! for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2013-4
Page17of1804-February-2014Labeode: 9907152
I Lupus Anticoagulant I ß2-Glycoprotein I Antibodies IgM
No. of Responders133
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
Externa! qua!ity Contra! for Assays and TestsWith a foeus on Thrambosis and Haemostasis
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
Participation rate: 38%
RemarksNone
Survey: 2013-4
Page 12 of 1804-February-2014Labeode: 9907152
I,ECATFOUNDATION
Externa! qua!ity Contra! for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2013-4
Page 10 of 1804-February-2014Labeode: 9907152
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.
FOUNDATION
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
Externa! qua!ity Contra! for Assays and TestsWith a foeus on Thrambosis and Haemostasis
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
~., .,ECAT. ~ FOUNDATION
Comments
Participation rate: 26%
RemarksNone
External quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2013-4
Page 18 of 1804-February-20 14Labeode: 9907152
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