ECAT FOUNDATION - LKF-Kiel · 2016-05-19 · ECAT FOUNDATION Extemal quality Contral forAssays and...
Transcript of ECAT FOUNDATION - LKF-Kiel · 2016-05-19 · ECAT FOUNDATION Extemal quality Contral forAssays and...
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
Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2016-1
Page 5 of 1804-mei-2016Labcode: 9907152
1 Lupus Anticoagulant
No. of Responders190
11 Mixing
Sampie NoSampie Details
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
No. of Responders238
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
Sampie NoSampie Details
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
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[CATFOUNDATlON
ILupus Anticoagulant
No. of Responders481
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
Sampie NoSampie Details
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
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[CATFOUNDATlON
I Lupus Anticoagulant
No. of Responders209
Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
IAntiCardiolipin Antibodies IgG
Survey: 2016-1
Page 11 011804-mei-2016Labcode: 9907152
Sampie NoSampie Details
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
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[(ATFOUNDATION
I Lupus Anticoagulant
No. of Responders189
External quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
IAntiCardiolipin Antibodies IgM
Survey: 2016-1
Page 13 of 1804-mei-2016Labcode: 9907152
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
range Your result z-score
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
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E(ATFOUNDATION
Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2016-1
Page 15 of 1804-mei-2016Labcode: 9907152
I Lupus Anticoagulant
No. of Responders178
I ß2-Glycoprotein I Antibodies IgG
Sampie NoSampie Details
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
range Your result z-score
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
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ECATFOUNDATION
External qua/ity Control for Assays and TestsWith a foeus on Thrombosis and Haemostasis
Survey: 2016-1
Page 17 of 1804-mei-2016Labeode: 9907152
ILupus Anticoagulant
No. of Responders152
Iß2-Glycoprotein I Antibodies IgM
Homogeneily Parameter
Sampie NoSampie Details
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
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~ [(AT~ FOUNDATlON
Comments
Participation rate: 27%
Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2016-1
Page 18 of 1804-mei-2016Labeode: 9907152
RemarksSeveral participants reported a result below the detection limit « (value]). These results were not included in thestatistical evaluation.
~I
ECATFOUNDATlON
Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
Survey: 2016-1
Page 16 of 1804-mei-2016Labeode: 9907152
Comments
Participation rate: 32%
RemarksSeveral participants reported a result above the measurement range (> [valueJ). These results were not included in thestatistical evaluation.
[CATFOUNDATION
Comments
Participation rate: 34%
Extema! qua/ity Contro! for Assays and TestsWith a foeus on Thrombosis and Haemostasis
Survey: 2016-1
Page 14 of 1804-mei-2016Labeode: 9907152
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
ILupus Anticoagulant
Extemal quality Contral for Assays and TestsWith a foeus on Thrambosis and Haemostasis
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
Page 6 of 1804-mei-2016Labeode: 9907152
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
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o 30,8
35
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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
Page 4 of 1804-mei-2016Labcode: 9907152
350
300
250
~200oo
'50
'00
• dRWT
• dAPTT
60
O~~~~~~~~gre~~are;"";"";"';""';NNNNMMMMoriori-<iv •
.00hß, .Siemens Palhromllnf .Sillmenl ActinFSL
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.tL HemoslL SynthA.
.Other .SielT\fJn•
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.I.LdRVVT!lCtfIen
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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
Page 2 of 1804-mei-2016Labeode: 9907152
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