ECAT FOUNDATION - LKF-Kiel · 2016-05-19 · ECAT FOUNDATION Extemal quality Contral forAssays and Tests WithafoeusonThrambosis andHaemostasis Survey: 2016-1 Page 5of 18 04-mei-2016

ECAT FOUNDATIONExternal quality Control for Assays and Tests

With a focus on Thrombosis and Haemostasis

REPORT

SURVEY 2016-1Lupus AnticoagulantLabeode 9907152

Copyright @ 2016ECAT Foundation

~ [CAT~ FOUNDATION

I Lupus Anticoagulant

No. of Responders297

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

I IScreening

Survey: 2016-1

Page 3 of 1804-mei-2016Labcode: 9907152

Homogeneily Parameter Lupus Anticoagulant ratio

Sampie NoSampie Details

Stability

Homogeneity

16.17Plasma strongly positive for Lupus AnticoagulantUnits: RatioPrior Use: None

31-december -2017

1.9 %

Assay Normal Borderline Prolonged No Your resultClassification

Screening 1 Screening 2 Screening 3APTI 3 1 323 1dAPTI 0 0 13 0dPT 0 0 8 0dRVVT 3 3 433 10 Prolonged ProlongedKCT 0 0 6 0Other 0 0 1 0PNP 1 0 1 0PT 1 0 4 0SCT 0 0 76 4

Ratio n 81SlgnlKl CV (%) rangevalue

panel 1 z.score panel 2 z.seore pane13 z-score

APTT 278 2.11 20.3 0.87 - 4.40I.L. APTT SP 39 2.83 18.6 1.88 - 3.65I.L. HemoslL SynthAsil 24 2.16 9.8 1.67 - 2.53I.L. Mixeon 7 2.05 1.34 - 2.33Siemens Actin FSL 46 1.78 10.6 1.00 - 2.25Siemens Pathromtin SL 22 1.68 10.6 1.33.2.36St_gO/Roche PTT 25 1.96 7.5 1.53 - 2.46St_go/Roche PTT LA 70 2.30 8.8 1.55 - 2.88St_gO/Roche St_clot LA 5 1.57 0.87 - 2.16Trinity Biotech Automated APTI g 1.90 1.63.2.15Trinity Biotech TriniClot APTI-HS g 2.20 2.04 - 2.44dAPTT 12 2.35 10.1 2.02 - 4.26SI_go/Roche PTT LA 10 2.34 7.3 2.16 - 2.67dPT 6 3.23 1.77 -4.34dRWT 391 2.34 8.4 0.86 - 4.05 2.06 '-1.40 2.19 -0.74American Diagnostics DWtest 8 2.32 2.14 - 2.56I.L. HemoslL dRVVT sereen 110 2.27 8.1 1.84 - 2.90I.L. LAC sereen 14 2.36 8.6 2.11-4.05Ufe Diagnostics LA sereen 11 2.35 2.7 2.29 - 2.65Precision Biologie LA check 15 2.87 10.0 2.46 - 3.52Siemens LA1 sereen 144 2.38 7.8 1.52-3.14 2.06 -1.70Stago I Rache DRVVT sereen 79 2.30 6.8 0.86.2.81Technoclone LA Seree" 7 2.24 1.65 - 2.38 2.19PT 5 1.31 1.20.1.35SCT 75 3.71 16.6 2.60 - 9.43Haematex SACT Reagent 6 5.97 4.90 - 6.94I.L. SeT sereen 69 3.62 14.7 2.60 - 9.43

ECATFOUNDATION


Survey: 2016-1


1 Lupus Anticoagulant


11 Mixing


16.17Plasma strongly positive for Lupus AnticoagulanlUnils: RatioPrior Use: None

Stability

Homogeneity

31-december-2017

1.9 % Homogeneily Parameter Lupus Anticoagulant ratio

Assay Normal Borderline Prolonged No Your resullClassificalion

Mixing 1 Mixing 2 Mixing 3APTI 4 8 230 2dAPTI 1 0 21 0dPT 0 0 5 0dRWT 4 3 238 3KCT 0 0 8 0Other 1 0 2 0PNP 1 0 1 0PT 0 0 1 0SCT 1 0 37 1

Ratio n asslgned CV (%) rangevalue

panel1 z~score panel2 z-score panel3 z-score

APTT 220 1.61 17.6 0.86 - 4.06I.L.APTT SP 25 2.03 6.0 1.78 - 2.26I.L. HemoslL SynlhAsil 19 1.77 10.1 1.47 - 2.32I.L. Mixeon 12 1.64 10.5 1.27 - 2.00Siemens Actin FSL 30 1.38 9.6 0.86.4.06Siemens Pathromtin SL 16 1.27 5.3 1.16-1.37SIa9o/Roche PTT 21 1.45 6.8 1.29-1.71Slago/Roche PTT LA 64 1.66 6.9 1.29 - 2.22Trinity Biotech Automated APlT 8 1.40 1.22 - 1.55Trinity Biotech Trinielot APTT-HS 7 1.61 1.49 -1.76dAPTT 21 1.64 16.3 1.07 - 3.72Slago/Roche PTT LA 11 1.66 10.0 1.48-1.90dPT 5 2.80 1.30 - 3.26dRVVT 231 1.75 10.6 1.03.2.811.L. HemoslL dRVVT sereen 36 1.81 10.0 1.20 - 2.20I.L. LAC sereen 6 1.89 1.73 - 2.22Ufe Diagnostics LA sereen 7 1.90 1.70 - 2.81Precision Biologie LA check 8 2.18 2.00 - 2.47Siemens LA1 sereen 100 1.69 8.3 1.17-2.33Siemens lA2 confirmation 5 1.10 1.03 - 1.45Stago I Roche DRVVT screen 54 1.76 9.9 1.06 - 2.42KCT 7 3.18 1.91 - 3.96Homemade Kaolin 6 3.16 1.91 - 3.96SeT 38 2.59 19.9 0.57 - 6.94Haematex SACT Reagent 5 3.19 0.57 - 6.94I.L.seT sereen 32 2.56 14.5 2.09 - 4.75

[(ATFOUNDATION

ILupus Anticoagulant


Extemal qua/ity Contral (or Assays and TestsWith a (oeus on Thrambosis and Haemostasis

I IConfirmation

Survey: 2016-1

Page 7 011804-mei-2016Labeode: 9907152

Homogeneily Parameter Lupus Anlicoagulant ratio


Stability

Homogeneily

16.17Plasma strongly positive for Lupus AnticoagulantUnits: RatioPrior Use: None31-december-2017

1.9 %

Assay Positive Borderline Negative No Your resultClassification

Confirm 1 Confirm 2 Confirm 3APTT 133 4 5 0dAPTT 12 0 1 0dPT 7 0 0 0dRWT 456 8 2 0 LA Positive LA PositiveOther 1 0 0 0PNP 14 0 0 0PT 1 0 0 0SCT 70 0 1 0

Ratio n asalgnedCV (%) rangev.IUD

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

APTT 84 1.36 16.2 0.84 - 2.81I.L.Hemosi!SynlhAFax 14 1.28 9.3 1.14.1.68I.L.MixCon 10 1.50 29.4 1.09 - 2.14Siemens Actin FS 34 1.26 10.6 0.84 - 1.87Slago/RocheSlaclotLA 7 1.34 1.20.1.98Technoclone Lupus Anticoagulant Test 5 2.74 1.79 - 2.81dAPTT 8 1.29 1.24 - 2.93dPT 7 1.72 1.30 - 3.40dRWT 394 1.23 9.3 0.43 - 3.30 1.05 -1.51 1.15 .0.65American Oiagnostics OWconfirm 6 1.36 1.09-1.82I.L. HemoslL dRVVT confirm 104 1.22 9.7 0.76.2.10I.L LAC confirm 20 1.24 9.2 1.08 - 2.59Life Diagnostics LA confirm 10 1.27 14.7 1.10-1.90Precision Biologie LA sure 14 1.37 24.0 1.05 - 2.64Siemens l.A2 confirmation 143 1.21 8.0 0.43 - 2.10 1.05 -1.59Slago/RocheDRWT Confirm 79 1.24 8.7 0.89 - 2.00Technoclone LA Confirm 7 1.22 1.09-1.33 1.15SCT 69 1.53 9.0 1.20 - 2.12I.L.SCTconfirm 69 1.53 9.0 1.20-2.12

?\?

/lJ. Os. /fJ

[CATFOUNDATlON



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

I Ratio Screening/Confinnation

Survey: 2016-1

Page 9 of 1804-mei-2016Labeode: 9907152

Homogeneity Parameter Lupus Anticoagulant ratio


Stabilily

Homogeneily

16.17Plasma strongly positive for Lupus AnlicoagulanlUnils: RalioPrior Use: None

31-december-2017

1.9 %

Ratio Screening/Confirmation n aaslgned CV (%) rangevalue

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

APTT 177 1.61 15.5 0.88 - 3.90dAPTT I 8 1.35 1.24-1.79dRVVT 435 1.94 10.4 0.79 - 3.33 1.99 0.22 1.83 -0.56SCT I 69 2.37 14.4 1.67 - 6.00

Assays

()L

"'b//3.$ 1&

[CATFOUNDATlON




IAntiCardiolipin Antibodies IgG

Survey: 2016-1

Page 11 011804-mei-2016Labcode: 9907152


16.17Plasma strongly positive lor Lupus AnticoagulantUnits: GPL, U/mL, CU/mL, OtherPrior Use: None

Stabilily

Homogeneily

31-december-2017

1.9 % Homogeneity Parameter Lupus Anticoagulant ratio

Classiflcation Negative Borderllne Low Positive Medium Positive High PosItive No Concluslon

I Total 0 1 0 19 187 2

IgG n asslgned CV (%)valu.

range Your result z-score

;Total Grou~ -GPL 117 135.5 35.2 17.6 - 823.0Aeskulisa Diagnotic GmbH 5 175.0 152.0 - 238.0INOVA Quanta Flash 5 102.0 82.0 - 108.0INOVA Quanta Lite 14 106.5 10.6 87.1 - 164.0Orgentec (Elisa) 19 93.7 24.5 34.0 - 120.0Thermo Scientific EliA 51 167.8 12.0 114.0 - 208.0U/mL 11 102.9 15.4 64.0 -1816.0Euroimmun 6 104.6 64.0.123.0CUlmL 33 931.5 8.7 805.0 - 5594.5I.L. Acustar 25 943.5 9.5 805.0 - 5594.5Other 9 135.0 3.5 - 217.0Thermo Scientific EliA 5 182.0 50.0 - 217.0

c,8 12

°M'Off'o. a)OMU)(l) •.•.••. "COCOCONml() •.•,...vOIDNO)I() •...m~~~g~:ggre~~~mc!~~v •.••..••...•.••.••...• N N N

• Ot~ • • Thel'TT\(J Sclenlille EIIA

.INOVA. QUlntl L~lI

[(ATFOUNDATION



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

IAntiCardiolipin Antibodies IgM

Survey: 2016-1


Homogeneity Parameter Lupus Anticoagulanl ralio

Sam pie NoSam pie Details

stabilily

Homogeneily

16.17Plasma slrongly posilive for Lupus AnlicoagulanlUnils: MPL, UlmL, CU/mL, OlherPrior Use: None31-december-2017

1.9 %

Classlfication Negative BorderUne Low Positive Medium Positive High Positive No Concluslon

I Total 147 25 13 1 1 2

IgM n 1S1Iigned CV (%)value


Total Graul! -MPL 137 7.4 57.1 1.0.66.0Aeskulisa Diagnotic GmbH 7 60 2.2.9.8Bio-rad 7 11.4 9.0 -12.3INOVA Quanta Lila 13 15.6 13.2 11.5-19.0Orgentec (Alegria) 14 5.6 19.5 4.0 - 8.1Orgentec (ElIsa) 20 8.2 16.8 4.0.66.0Other 5 5.2 2.0-10.0Reaads 5 12.0 7.9 -15.9Thermo Scientific EliA 47 4.4 20.8 2.4 - 7.0UlmL 14 8.0 37.4 3.8 - 36.0Euroimmun 6 8.4 4.4 - 10.1CUlmL 27 9.8 9.5 8.5 - '1.0I.L. Acustar 23 9.9 86 8.5.11.0Other 7 4.0 0.2 -10.4

35

25

~, 20

8

10

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.Otller _Ot\tentec(A.legna) •Thermo Selenllfie EliA .INOVA auanta L"e

E(ATFOUNDATION


Survey: 2016-1




I ß2-Glycoprotein I Antibodies IgG


16.17Plasma strongly positive for Lupus AnticoagulantUnits: U, ~g/mL, U/mL, CU/mL, OtherPrior Use: None

Stability

Homogeneity

31-december-2017

1.9 % Homogeneily Parameter LupusAnticoagulantratio

ClasslficationNegative Borderllne Low Positive Medium Positive High Positive No Concluslon

I Total 3 1 1 18 150 5

IgG n asslgned CV (%)\/alue


Ratio 22 10.4 109.0 0.1 -60.0-

U 87 123.2 45.8 1.8 -1400.0Aeskulisa Oiagnotic GmbH 6 88.3 1.8 - 427.0INOVA Quanta Flash 5 61.0 49.0 - 84.0INOVA Quanta Lite 9 67.6 52.6 - 93.0Orgentec (Ellsa) 16 83.5 19.2 61.8 - 102.0Thermo Scientific EliA 37 156.2 10.3 112.0 - 203.0~glmL 3 76.3 4.7 - 144.0UlmL 14 160.4 32.4 20.0 - 5424.6Euroimmun 5 192.1 160.0 - 194.0CUlmL 26 5942.4 13.5 930.6 - 7799.7I.L. Acustar 23 6053.7 12.5 930.6 - 7799.7Other 16 121.9 68.4 3.2 - 5673.6Thermo Scientific EliA 8 156.0 145.0 - 165.0

"14

12

1: 10,.3 •

•

O~~~~~~~~~«!~Ci:i«i~~~:;;';~~~8~P:~::g~~~Nv •..••.•.••••.•.•.•..•..••.••.•..• A

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ECATFOUNDATION

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

Survey: 2016-1




Iß2-Glycoprotein I Antibodies IgM

Homogeneily Parameter


Stability

Homogeneity

16.17Plasma strongly positive for Lupus AnticoagulantUnits: U. U/mL, CU/mL, OtherPrior Use: None

31-december-2017

1.9 % Lupus Anticoagulant ratio

Classification Negative SorderUne Low Positive Medium Positive High Positive No Concluslon

I Total 112 21 8 7 3 1

IgM n asslgned CV (%)value

Your result z-score

Ratio 19 1.2 70.9 0.2 - 9.9-

U 90 7.3 50.6 0.0 - 47.7Aeskulisa Diagnotic GmbH 6 7.8 2.3 - 24.0INOVA Quanta Lile 6 11.0 0.0 -13.8Orgentec (Alegria) 12 4.2 15.6 3.4 - 5.5Orgentec (Elisa) 17 6.6 25.8 4.0 -13.0Reaads 5 16.4 13.2.20.7Thermo Scientific EliA 29 6.3 19.5 3.5 - 8.3~glmL 2 4.7 1.8-7.6UlmL 17 26.9 101.6 5.0 - 64.0Euroimmun 5 58.0 51.0 - 64.0CUlmL 25 10.2 11.2 8.1-12.2I.L. Acustar 22 10.4 9.9 8.3 - 12.2Other 15 7.4 55.9 0.6 - 60.8Thenno Scientific EliA 8 6.1 4.0 - 8.0

C 12,8

8

.00her .OrgenlllC(Alognl) •Thermo SCienllfic EliA

~ [(AT~ FOUNDATlON

Comments

Participation rate: 27%


Survey: 2016-1


RemarksSeveral participants reported a result below the detection limit « (value]). These results were not included in thestatistical evaluation.

~I

ECATFOUNDATlON


Survey: 2016-1


Comments


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

[CATFOUNDATION

Comments


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

Survey: 2016-1


RemarksSeveral participants reported a result below the deleclion Iimil « (value]). These resulls were nol included in lheslatislical evaluation.

ECATFOUNDATION

Extemal qua/ity Contral 'ar Assays and TestsWith a 'oeus on Thrambosis and Haemostasis

Survey: 2016-1

Page 12 of 1804-mei.2016Labeode: 9907152

Comments

participation rate: 38%

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

[CATFOUNDATION



I IFinal Conclusion

Survey: 2016-1

Page 10011804-mei-2016Labeode: 9907152

Final ConcluslonNegative Borderllne Positive No Conclusion Your Result

I Total 1 4 435 41 Positive

CommentsIn total 440 participants gave a linal conclusion. Forty-one participants (9%) gave no final conclusion.

The sam pie used in this survey was plasma lram a patient diagnosed with strang Lupus Anticoagulant. The patient wasnot under treatment at the time 01blood sampling.

01 the participants who gave a linal conclusion, 99% c1assified the sam pie correctly as positive.Several participants stated that there is an indication that this sampie is positive lor lupus anticoagulant but in realclinical practice this should be conlirmed in a new sampie after 12 weeks.Also a number 01participants indicated that the positivily 01the lupus anticoagulant test could also be caused bytreatment 01the patient with direct anticoagulants. This should be excluded.

Assays

ECATFOUNDATION

Extemal qua/ity Contral 'or Assays and TestsWith a 'oeus on Thrambosis and Haemostasis

Survey: 2016-1

Page 8 01 1804-mei-2016Labeode: 9907152

CommentsAlmost all (approx. 97%) performed conlirmation tests were classified as positive.

~ [(AT........ ~ FOUNDATION

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

Survey: 2016-1


Assays DRVVT

" 50

'0

.Oll'ler .Siemltn~Pelhromlln f .Slemel\ll Actin FSl .011>11' .Slemens

.tL APTI SP .S1agolRoche PTTLA .Stag<:w'Roeh"PTT .tL dRWT 5lnfIn

.tL Hemosll Syntl'lAs

• SlagaRoche

o~re~~~~~~~~3~~M~"';""';"";""";"":"":''''':'''':''':'''';NNNNNv A

20

o 30,8

35

c,ou

c,oU 1

CommentsAlmost all (approx. 96%) performed mixing tests were c1assified as prolonged.

Assays

External qua/ity Control tor Assays and TestsWith a {oeus on Thrombosis and Haemostasis

DRYVT

Survey: 2016-1


350

300

250

~200oo

'50

'00

• dRWT

• dAPTT

60

O~~~~~~~~gre~~are;"";"";"';""';NNNNMMMMoriori-<iv •

.00hß, .Siemens Palhromllnf .Sillmenl ActinFSL

.IL APTTSP .SlagoJRoche PTTLA • StllQ~oehePTT

.tL HemoslL SynthA.

.Other .SielT\fJn•

.',L .Prve BkIl

.I.LdRVVT!lCtfIen

.UIIlOleg.SlagaRocIle

CommentsAlmost all (approx. 99%) performed screening tests were c1assified as prolonged.

[CATFOUNDATION

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

Survey: 2016-1


Date of Issue

Survey

Report

04-me~2016

2016-1

Lupus Antieoagulant

Note:In the Survey Manual 2016 detailed information is given regarding the ECAT external qualily assessment programme,ineluding the statistieal evaluation and explanation of the report.This Survey Manual 2016 should be eonsidered as an integral part of this survey report.

General Information

Currently there are 553 partieipants registered for the Lupus Antieoagulant module. In totally 481 participants havesubmitted results. The response rate is 87%.

Antiphospholipid AntibodiesWe have now introdueed !Wo new units for the evaluation of the phospholipid antibody results (U/mL and CU/mL).From next survey on these will also be available in the unit seleetion of the online result submission faeilily. Please beaware 10 seleellhe appropriate unil for your melhod.

ComplaintsAny eomplaints regarding this survey report should be reported to the ECAT befare June 15th, 2016.Complaints reeeived after this date will not be proeessed anymore.

P.MeijerExeeutive Direetor

Note: A printed version of the aetual Survey Manual is provided to all partieipants onee a year. This manual ean also bedown loaded from the member seetion of the ECAT website.

ECAT Foundalion

DlrectOf: Or. P. MeijerECAlOfflceP.o. Box 1072250 AC Voorschotef\ 100 Natherlandsphone +31(0) 713030910. fax + 31 (0) 713030919E-mait inlo@ecalnlWebsile: www.ecalnlVAl number: N1802836872B01

Registrstion numberwith the Chamberof Commerce (KvK) Gouda: 41174102An the ususl condilions are applicable to eil aur services

All fights reserved. No part of {his rapart mey be reproduced, stored in a retriever 'yslel1\ cr transmitted in any form cr by means, electronic, mechanica( photocopying, recording or othefWise, without priorpermissionfrom lhe ECAl FoundalionAppendixes are an integral part 01Ihe tolal raport

http://www.ecalnl

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ECAT FOUNDATION - LKF-Kiel · 2016-05-19 · ECAT FOUNDATION Extemal quality Contral forAssays and Tests WithafoeusonThrambosis andHaemostasis Survey: 2016-1 Page 5of 18 04-mei-2016