ECAT FOUNDATION - LKF · 2015. 12. 16. · Page 150120 12-May-2015 Labeode: 9907152 Sampie No Sampie Details Stability Homogeneity 15.17 Plasma strongly positive lor Lupus Anticoagulanl

ECAT FOUNDATIONExternal quality Control for Assays and Tests

With a focus on Thrombosis and Haemostasis

REPORT

SURVEY 2015-1lupus Anticoagulantlabeode 9907152

Copyright @ 2015ECAT Foundation

[CATFOUNDATlON

External qua/ity Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis

Survey: 2015-1

Page 30f2012-May-2015Labeode: 9907152

Date of Issue

Survey

Report

12-May-2015

2015-1

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 havesubmilted results. The response rate is 90%.

P.MeijerExecutive Director

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 section of the ECAT website.

[CATFOUNDATION

ILupus Anticoagulant

No. of Responders304

Externa/ qua/ity Contro/ for Assays and TestsWith a foeus on Thrombosis and Haemostasis

I IScreening

Survey: 2015-1

Page 5 012012-May-2015Labcode: 9907152

Sampie NoSampie Details

Stability

Homogeneily

15.17Plasma strongly positive lor Lupus AnticoagulantUnits: RatioPrior Use: None

31-January-2017

2.1 %

Assay Normal Borderline Prolonged No Your resultClassification

Screening 1 Screening 2 Screening 3APTT 2 2 330 5dAPTT 1 0 16 0dPT 1 0 9 0dRVVT 1 1 440 10 Prolonged ProlongedKCT 0 0 9 0Other 0 0 1 0PNP 0 0 2 1PT 0 0 3 0SCT 0 0 73 5

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External qua/ity Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis

11 Mixing

Survey: 2015-1

Page 7 of 2012-May-2015Labcode: 9907152


Stability

Homogeneity

15.17Plasma strongly positive for Lupus AnticoagulantUnits: RalioPrior Use: None

31-January-2017

2.1 %

Assay Normal Borderline Prolonged No Your resullClassification

Mixing 1 Mixing 2 Mixing 3APTT 12 6 241 3dAPTT 1 0 23 0dPT 0 0 5 0dRVVT 4 2 240 3KCT 0 0 12 0Olher 0 0 2 0PNP 0 0 3 0PT 1 0 1 0SCT 1 0 36 0

Ratio n 81!lsignedCV (%) rangevalue

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

APTT 228 1.67 21.3 0.86 - 3.59I.L. APTT SP 25 2.08 5.5 1.76 - 2.29I.L. HemoslL SynthAsil 20 1.82 9.1 1.46 - 2.25I.L. Mixeon 12 1.76 12.1 1.16-2.17Siemens Actin FSl 38 1.31 13.6 0.86 -1.65Siemens Pathromtin SL 17 1.32 8.5 1.16-1.79Stago/Roche PTT 21 1.46 7.8 1.11.2.00Slago/Roche PTT LA 60 1.80 8.3 1.09 - 2.87Trinity Biotech Automated APTT 8 1.42 1.23.1.64Trinity 8iotech TriniClot APTI-HS 7 1.63 1.50 - 3.59dAPTT 22 1.80 16.0 1.29 - 2.91Stago/Roche PTT LA 11 1.80 9.1 1.62.2.40dRWT 225 1.80 9.6 0.90 - 2.71American Diagnostics DWtest 5 1.93 1.36 - 2.01I.L. HemoslL dRWT screen 40 1.91 8.8 1.60 - 2.71Life Diagnostics LA screen 10 1.91 6.9 1.62 - 2.09Precision Biologie LA check 8 2.34 2.05 - 2.44Siemens LA1 screen 101 1.74 7.9 1.01 - 1.99Siemens lA2 confirmation 7 1.53 0.90.1.728tago I Rache DRWT screen 39 1.83 7.7 1.50 - 2.62KCT 10 2.51 44.7 0.22 - 4.62SCT 36 2.60 26.9 0.49 -7.11Haematex SACT Reagent 8 3.26 0.49-7.11I.L. SeT screen 27 2.57 18.5 0.98 - 3.55

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Extemal qua/ity Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis

Survey: 2015-1

Page 9 012012-May-2015Labeode: 9907152


No. 01 Responders239

I IConfirmation


Stabilily

Homogeneily

15.17Plasma strongly positive lor Lupus AntieoagulantUnits: RatioPrior Use: None31-January-2017

2.1 %

Assay Positive Borderline Negative No Your resultClassilieation

Confirm 1 Confirm 2 Confirm 3APTT 133 2 5 2dAPTT 10 1 1 0dPT 8 0 0 0dRVVT 452 8 4 2 LA Positive LA PositiveKCT 1 0 0 0Other 1 0 0 0PNP 13 0 3 0PT 2 0 1 0SCT 69 0 0 0

Ratio n ISligned CV (%) rangevalue

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

APTT 91 1.37 17.3 0.37 - 4.671.L. Hemosil SynthAFax 12 1.24 3.4 1.19 -1.53I.L. Mixeon 11 1.49 31.1 1.12-2.20Siemens Actin FS 34 1.24 7.2 1.08 - 1.46Sta9o/Roche Slaclot LA 13 1.62 46.4 0.37 - 4.67Technoclone Lupus Anticoagulant Test 6 2.72 1.89 - 3.89dAPTT 7 1.33 1.20 -1.57dPT 7 1.58 1.41-1.90dRWT 388 1.27 84 0.95 - 3.27 1.18 -0.84 1.25 -0.22American Diagnostics DWconfirm 9 1.33 1.23-1.51I.L. HemoslL dRVVT confirm 93 1.27 7.7 1.02 - 2.46I.L LAC confirm 22 1.27 8.2 1.10-2.27Life Diagnostics LA confirm 16 1.23 10.8 1.06-1.43Precision Biologie LA sure 14 1.30 14.1 1.06 - 3.27Siemens lA2 confirmation 142 1.26 7.4 0.95 - 2.50 1.18 -0.80StagoiRoche DRWT Confirm 70 1.28 8.8 1.08 - 2.00Technoclone LA Confirm 7 1.25 1.10-1.30 1.25PNP 6 1.49 0.77-2.11SeT 64 1.48 10.7 0.69 - 3.10I.L seT confirm 63 1.48 10.9 0.69 - 3.10

ECATFOUNDATION

External quality Control {ar Assays and TestsWith a {oeus on Thrombosis and Haemostasis

Survey: 2015-1

Page 11 012012-May-2015Labeode: 9907152



IRatio Screening/Confinnation

Sam pie NoSampie Details

Stability

Homogeneity

15.17Plasma strongly positive lor Lupus AnticoagulantUnits: RatioPrior Use: None

31-January-2017

2.1 %

Ratio Screening/Confirmation n IIsslgned CV (%) rangeYldue

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

APTT 177 1.64 19.6 1.09 - 2.64dAPTT I 6 1.70 1.12-2.02dRVVT 438 1.99 10.6 1.09 - 3.14 2.02 0.16 1.97 .0.08SeT I 66 2.42 12.5 1.68 - 5.81

Assays

'80

180

,.0120

c6100()

60

40

20

.'",

[CATFOUNDATION



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

IAntiCardiolipin Antibodies IgG

Survey: 2015-1

Page 13012012-May-2015Labeode: 9907152


Stabilily

Homogeneily

15.17Plasma strongly positive lor Lupus AnticoagulantUnits: GPL, ~g/mL, OtherPrior Use: None

31-January-2017

2.1 %

Classification Negative Borderllne Low Positive MedIum Positive High Positive No Conc1usion

I Total 4 1 1 17 182 1

IgG n Blllligned CV (%)value

range Your result z-score

'fatal Group • , - . ",,"GPL 137 142.4 42.9 0.0 - 2752.0Corgenix REAADS 7 83.6 54.6 - 121.0Euroimmun 9 120.0 5.1 - 245.0INOVA Diagnostics lnc. 22 98.7 11.5 42.7 - 198.0Orgentec 14 106.2 29.4 68.8 - 228.8Orgentec (Alegria) 5 120.0 91.5 - 188.0Phadia 53 184.9 14.4 21,3 - 230.0~g1mL 1 1.2 1.2 -1.2Other 25 1020.2 20.3 2.6 -1574.0I.L. Acustar 17 1063.5 15.8 840.0 - 1574.0

"20

"",oo 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)Nv •..•••• ..- •••••• NNNA

.Otller .INOVA .Orgentec

.Phadll

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I Lupus Anticoagulant


External qua/ity Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis

IAntiCardiolipin Antibodies IgM

Survey: 2015-1

Page 15 012012-May-2015Labeode: 9907152


Stability

Homogeneity

15.17Plasma strongly positive lor Lupus AnticoagulanlUnits: MPL, IJg/mL, OtherPrior Use: None31-January-2017

2.1 %

ClassificationNegative Bordertine Low Positive Medium Positive High Positive No Conclusion

I Total 136 18 27 2 2 1

IgM n asalgned CV (%)value


iTöläl GroUIl -MPL 154 6.9 46.6 0.6 - 32.0Aeskulisa Diagnotic GmbH 5 6.7 1.2-16.0Bio-rad 7 11.2 9.0 - 14.0Corgenix REAADS 7 14.3 11.0-16.0Euroimmun 11 6.4 32.6 0.6 -15.4INOVA Diagnostics Ine. 21 16.6 25.4 11.0 - 30.5Orgentec 16 6.2 16.9 5.0 -12.6Orgentec (Alegria) 13 6.7 27.0 4.6 - 11.4Phadia 49 6.1 17.6 4.0 - 6.5~glmL 1 0.2 0.2 - 0.2Other 21 9.6 23.1 0.6-31.3I.L. Acustar 15 9.9 14.0 6.2 -13.2

70

c,ou

.00""

.Orgllnlec.Eurolmmun .INOVA• Oroenlec (Aleoria) • Phadia

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Survey: 2015-1

Page 17 of 2012-May-2015Labeode: 9907152



Iß2-Glycoprotein I Antibodies IgG

Sam pie NoSam pie Details

Stability

Homogeneity

15.17Plasma strongly positive for Lupus AnticoagulantUnits: U, ~g/mL, OtherPrior Use: None

31.January.2017

2.1 %

Classification Negative Borderline Low Positive Medium Positive High Positive No Conclusion

I Tolal 2 2 5 23 142 1

IgG n BSligned CV (%)value


Ratio 26 8.5 104.0 0.5 - 8.8.

U 113 125.1 48.0 5.4 - 1300.0Aeskulisa Diagnotic GmbH 8 19.3 5.4 - 58.0Corgenix REAADS 7 154.2 137.0 -184.1INOVA Diagnostics Inc. 18 68.3 36.1 12.1-108.3Orgentec 15 98.5 24.2 66.6 -141.0Phadia 47 163.9 14.0 55.0 - 204.0~glmL 1 1.2 1.2 - 1.2Qther 29 3772.1 96.1 3.2 - 8059.8Euroimmun 8 192.1 4.4 - 317.0I.L. Acustar 13 6383.0 20.3 4674.2 - 8059.8

y.

14

C 10,oU 8

8

[(ATFOUNDATION

Extemal qua/ity Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis

Survey: 2015-1


I Lupus Anticoagulant


Iß2-Glycoprotein I Antibodies IgM


Stability

Homogeneity

15.17Plasma strongly positive for Lupus AnticoagulantUnits: U, IJg/mL, OtherPrior Use: None

31-January-2017

2.1 %

Classlficatlon Negative Borderllne low Positive Medium PosItive HIgh Positive No Concluslon

I Total 108 18 13 8 2 0

IgM n lIsalgned CV (%)vatue

Your re5uft z-score

Ratio 23 1.4 74.1 0.1-7.0.

Seleet trom list 3 10.0 6.0 -10.7U 104 7.8 46.3 1.0.54.7Aeskulisa Diagnotic GmbH 6 2.8 1.0 -13.0Corgenix REAADS 6 18.1 14.8 - 22.0INOVA Diagnostics Inc. 12 11.6 12.9 9.7 -54.1Orgentec 15 6.4 21.4 2.5 - 7.8Orgentec (Alegria) 11 4.4 33.3 1.7-18.8Phadia 37 6.6 16.8 4.0 - 9.4~glmL 3 6.0 0.2 - 9.1Other 34 15.8 86.5 0.5 - 104.0Euroimmun 7 59.0 51.0 -104.0I.L. Acustar 12 9.9 12.2 8.3-13.7

"

c,oU 12

4

.Olller .INOVA

.OfvenlllC(Alegn8) .Phadll.OflllllllllC

[CATFOUNDATION

Comments

Participation rate: 28%

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

Survey: 2015-1


RemarksSeveral participants reported a result below the deteclion limit «[value]). These resulls were nol included in lhestatislical evalualion.

[CATFOUNDATION

Comments


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

Survey: 2015-1


RemarksSeveral participants reported a result above the measurement range (> [value]). These results were not included in thestatistica! evaluation.

ECATFOUNDATION

Extemal qua/ity Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis

Survey: 2015-1


Commenls

Participalion rale: 35%

RemarksSeveral participanls reported a resull below lhe deleclion limil «[value]). These resulls were nol included in lheslalislical evalualion.

[CATFOUNDATION

Comments


Externa! qua/ity Contro! for Assays and TestsWith a foeus on Thrombosis and Haemostasis

Survey: 2015-1


RemarksSeveral participants reported a result above the measurement range (> [value]). These results were not included in thestatistical evaluation.

~ [CAT~ FOUNDATION


Extemal quality Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis

I IFinal Conclusion

Survey: 2015-1


Final ConclusionNegative SorderUne Positive No Concluslon Your Result

I Total 4 5 429 45 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.

=E C-A-T-- Extemal quality Contral (or Assays and Tests"G With a (oeus on Thrambosis and Haemostasis

FOUNDATION

Assays

'so

300

_2SOC,o02

1SO

CommentsAlmost all performed conlirmation tests were classilied as positive (96%).

Survey: 2015-1

Page 10012012-May-2015Labeode: 9907152

ATFOUNDATION

Extemal qua/ity Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis

Survey: 2015-1

Page 8 012012-May-2015Labeode: 9907152

.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

4()

,

'"

",ou

PRWT

5

25

3

10

10

", 20oU

.dRWT

.dAPTT

100

40

24()

200

c,o0120

Assays

CommentsAlmost all performed mixing tests were c1assilied as prolonged (>95%).

[(ATFOUNDATION

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

Survey: 2015-1


Ratio n Illslgned CV (%) rangevalue

panel 1 z-score panel 2 z.score panel 3 z~score

APTT 273 2.23 23.6 1.20 - 3.85I.L APTTSP 39 2.95 16.6 1.94 - 3.70I.L HemoslL SynlhAsil 22 2.11 9.7 1.78 - 2.70I.L MixCon 9 2.14 1.37 - 2.44Siemens Actin FSl 44 1.78 11.5 1.20-2.15Siemens Pathromtin SL 26 1.80 5.4 1.55.2.34StagoiRoche APTI-Kaolin 5 1.71 1.64.2.85SlagolRoche PTT 26 1.99 7.4 1.63 - 2.34Slago/Roche PTT LA 65 2.56 9.9 1.47.3.07Trinity 8iotech Automated APTI 8 1.95 1.63.2.14Trinity Biotech TriniClot APTI-HS 10 2.26 3.6 2.03.3.85dAPTT 14 2.57 9.4 1.66.3.39Stago/Roche PTT LA 10 2.59 7.3 2.13 - 2.83dPT 8 3.63 1.45 - 5.55dRVVT 381 2.47 8.4 1.22 - 4.08 2.17 .1.43 2.20 .1.29American Diagnostics DWtest 9 2.49 2.20.2.77I.L HemoslL dRVVT screen 94 2.44 9.0 1.91 .3.97I.L LAC screen 18 2.51 9.5 2.21 .4.08Life Diagnostics LA screen 17 2.37 14.0 1.73.3.00Precision Biologie LA check 16 3.15 8.7 2.32.3.61Siemens LA1 screen 141 2.48 6.2 1.74.3.20 2.17 -2.00Stago I Rache DRVVT screen 69 2.42 7.0 1.82.3.11Technoclone LA Scree" 7 2.31 1.87 - 2.49 2.20KCT 7 4.13 1.88 - 4.62SCT 72 3.56 12.9 2.60-7.11Haematex SACT Reagent 6 4.13 3.21 - 7.11I.L SCT screen 66 3.53 12.3 2.60.4.78

Assays DRWT28 '80

O,..r--•....""""""(O(O (0(0(0(0M'<tlD(oON'<tlD(OON'<tlD(oo)"':"':"':"':NNNNNMMMMMMv ,

20

"

eo

'20

,,,

~,c,oo 80

.Oll\ef .Sjemen!

.1.L .PnIC8101

.1,LdRVVTlICl"een

•..•..•..•...NNNNMMMMvvvV ,

20

c,oo

'0

.Otrw .Slemens Palhromlin~ .S;flmensAdm FSL

.tL APTT SP • St8ll~oehe PTTlA • Stllllu'RodIe PTT

.IL HemoslL Sl'fltllAS

.'''TI.dRWT.dAPTT

'0

80

120

'",~5 ,oo

CommentsAlmost all performed screening tests were classified as prolonged (>98%).

[CATFOUNDATION

ECAT Foundation


Survey: 2015-1


Director: Cr. P. MeijerECAT OfficeP,O. Box 1072250 AC Voorscholen, The Nelherlandsp/1one +31(0) 713030910: fal( + 31jO) 713030919E-mail info@ecalnlWebsile: wwwecatnlVAT number: NLB02836872B01

Reglslralion number Wllh the Chamber 01 Commerce (KvK) Gouda: 41174102Aillha 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 priorpermission from the ECAT FoundalionAppendixes are an integral part of IM total report

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External qua/ity Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis

Survey: 2015-1


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ECAT FOUNDATION - LKF · 2015. 12. 16. · Page 150120 12-May-2015 Labeode: 9907152 Sampie No Sampie Details Stability Homogeneity 15.17 Plasma strongly positive lor Lupus Anticoagulanl