ECAT FOUNDATION REPORT

Transcription

1 ECAT FOUNDATION External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis REPORT SURVEY 218-M2 Labcode ECAT Foundation

2 Ec AT Exitheranafol cqusaloityn CThornotmrobl foosrisaas nsadyfis aenino d Tests is FOUNDATION Page 3 of 18 Sample No Sample Details Prior Use Unit Expiry Date Homogeneity Number of Participants Number of Responders Screening Plasma positive for (LA Ratio approx. 1.6) Prior Use: None Units: Ratio 11-March % Homogeneity Parameter LA Ratio Response Rate 86% Assay Normal Borderline Prolonged No Classification Your result Screening 1 Screening 2 Screening 3 APTT daptt 16 dpt drvvt Prolonged KOT 5 Other 1 1 PT 2 5 SCT 1 4 Ratio n assigned CV (%) range panel 1 value z-score panel 2 z-score panel 3 z-score APTT I.L. APTT SP I.L. HemosIL SynthAsil I.L. MixCon Siemens Actin ES Siemens Actin FSL Siemens Pathromtin SL Stago/Roche PTT Stago/Roche PTT LA Stago/Roche Staclot LA Trinity Biotech Automated APTT Trinity Biotech TriniClot APTT-HS daptt Stago/Roche PTT LA dpt drvvt American Diagnostics DVVtest I.L. HemosIL drvvt screen I.L. LAC screen Precision Biologic LA check Siemens LA1 screen Stago / Roche DRVVT screen Tcoag TriniClot Lupus Screen Technoclone LA Screen PT SCT Haematex SACT Reagent I.L. SCT screen ei 4

3 ECAT r FOUNDATION Ex.temal quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis Page 5 of 18 Mixing Sample No Sample Details Prior Use Unit Expiry Date Homogeneity Number of Participants Number of Responders Plasma positive for (LA Ratio approx. 1.6) Prior Use: None Units: Ratio 11-March A Homogeneity Parameter LA Ratio Response Rate 61% Assay Normal Borderline Prolonged No Classification APTT daptt 3 16 dpt dr\nt KCT 4 Other 1 2 PNP 1 PT 2 SCT 5 2 Your result Mixing 1 Mixing 2 Mixing 3 Ratio assigned CV range panel 1 z-score panel 2 z-score panel 3 z-score value APTT I.L. APTT SP I.L. HemosIL SynthAsil I.L. MixCon Siemens Actin FSL Siemens Pathromtin SL Stago/Roche PTT Stago/Roche PTT LA Trinity Biotech Automated APTT Trinity Biotech TriniClot APTT-HS daptt Stago/Roche PTT LA dpt drvvt I.L. HemosIL drvvt screen I.L. LAC screen Precision Biologic LA check Siemens LA1 screen Stago / Roche DRVVT screen Technoclone LA Screen SCT Haematex SACT Reagent I.L. SCT screen Je,9,"?

4 T External quality Control for Assays and Tests '13 A With a focus on Thrombosis and Haemostasis 44k EC FOUNDATION Page 7 of 18 Sample No Sample Details Prior Use Unit Expiry Date Homogeneity Number of Participants Number of Responders Confirmation Plasma positive for (LA Ratio approx. 1.6) Prior Use: None Units: Ratio 11-March % Homogeneity Parameter LA Ratio Response Rate 85% Assay Positive Borderline Negative Na Classification Your result Confirm 1 Confirm 2 Confirm 3 APTT daptt 16 1 dpt 4 7 drvvt LA Positive Other 1 1 PNP 9 2 PT 1 SCT 95 2 Ratio n assigned CV (%) range value panel 1 z-score panel 2 z-score panel 3 z-score APTT I I.L. Hemosil SynthAFax I.L. MixCon Siemens Actin FS Stago/Roche Staclot LA daptt dpt drvvt American Diagnostics DVVconfirm I.L. HemosIL drvvt confirm I.L. LAC confirm Precision Biologic LA sure Siemens LA2 confirmation Stago/Roche DRVVT Confirm Tcoag TriniClot Lupus confirm Technoclone LA Confirm SCT I.L. SCT confirm c.. 4'

5 Extemal quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis 4, EC AT FOUNDATION Page 9 of 18 Ratio Screening/Confirmation Sample No Sample Details Plasma positive for (LA Ratio approx. 1.6) Prior Use Prior Use: None Unit Units: Ratio Expiry Date 11-March-22 Homogeneity 2.2 % Homogeneity Parameter Number of Participants 598 Number of Responders 53 Response Rate LA Ratio 88.63% Ratio Screening/Confirmation n assigned CV (%) range panel 1 z-score panel 2 z-score panel 3 z-score value APTT daptt dpt drvvt SCT , Assays b' 12- o "Cro cb ce N.. 1 co C 4-- r - co N LC) h - CO N 41 gro) CD d * V A Other PdRVVT APTT SCT

6 External quality Control for Assays and Tests Ec AT With a focus on Thrombosis and Haemostasis FOUNDATION Page 11 of 18 Sample No Sample Details Prior Use Unit Expiry Date Homogeneity Number of Participants Number of Responders AntiCardiolipin Antibodies IgG Plasma positive for (LA Ratio approx. 1.6) Prior Use: None Units: GPL, U/mL, CU/mL 11-March % Homogeneity Parameter LA Ratio Response Rate 36% Classification Negative Borderline Low Positive Medium Positive High Positive No Conclusion Total IgG assigned CV (%) range Your result z-score value Total Group - GPL Aeskulisa Diagnotic GmbH Bio-rad Biorad Bioplex INOVA Quanta Lite Orgentec (Alegria) Orgentec (Elisa) Reaads Thermo Scientific EliA U/mL Euroimmun CU/mL I.L. Acustar / INOVA Quanta Flash GPL r ZO az. rellehlgill ) co N. P. ( (c. g :4 - '4 773,1 N cri cci ci cci cci (Ni N NNN A BOther Ongentec (Alegria) Thermo Scientific EliA INOVA Quanta Lite

7 .ikecat.," FOUNDATION External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis Page 13 of 18 Sample No Sample Details Prior Use Unit Expiry Date Homogeneity Number of Participants Number of Responders AntiCardiolipin Antibodies IgM Plasma positive for (LA Ratio approx. 1.6) Prior Use: None Units: MPL, U/mL, CU/mL 11-March % Homogeneity Parameter LA Ratio Response Rate 32% Classification Negative Borderline Low Positive Medium Positive High Positive No Conclusion Total IgM assigned CV (%) range Your result z-score value Total Group MPL Aeskulisa Diagnotic GmbH Bio-rad INOVA Quanta Lite Orgentec (Alegna) Orgentec (Elisa) Reaads Thermo Scientific EliA U/mL CU/mL I.L. Acustar / INOVA Quanta Flash _ MPL il 6 co In Tilerel 4- en_, cb (,) dr, V r - ce co nr t..- CD Cs1 N. ty) CO e CNJ ci c,i ei LO N: co d ei e: «5 r-: oi ä CN 1111 Ot h e r morgentec (Alegria) B Therme Scientific EliA INOVA Quanta Ute A /3?

8 T External "wr FOUNDATION quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis Page 15 of 18 Sample No Sample Details Prior Use Unit Expiry Date Homogeneity Number of Participants Number of Responders ß2-Glycoprotein I Antibodies IgG Plasma positive for (LA Ratio approx. 1.6) Prior Use: None Units: U, U/mL, CU/mL 11-March % Homogeneity Parameter LA Ratio Response Rate 31% Classification Negative Borderline Low Positive Medium Positive High Positive No Conclusion Total IgG assigned CV (%) range Your result z-score value Ratio U Aeskulisa Diagnotic GmbH Bio-rad INOVA Quanta Lite Orgentec (Alegria) Orgentec (Elisa) Reaads Thermo Scientific EliA U/mL Euroimmun CU/mL I.L. Acustar / INOVA Quanta Flash O Other 6erloolemfecei e co v cr) cn cn ce cn c» 5 OD CO OD CO co CD c.; CO CO d d C l Aeskulisa The rmo Scientitic EliA C 1 A Orgentec (Alegria) INOVA Quanta Ute

9 Ec A FOUNDATION External quality Control for Assays and Tests VVith a focus on Thrombosis and Haemostasis Page 17 of 18 Sample No Sample Details Prior Use Unit Expiry Date Homogeneity Number of Participants Number of Responders ß2-Glycoprotein 1 Antibodies 1gM Plasma positive for (LA Ratio approx. 1.6) Prior Use: None Units: U, U/mL, CU/mL 11-March % Homogeneity Parameter LA Ratio Response Rate 26% Classification Negative Borderline Low Positive Medium Positive High Positive No Conclusion Total IgM assigned CV (%) value Your result z-score Ratio U Aeskulisa Diagnotic GmbH Bio-rad INOVA Quanta Lite Orgentec (Alegria) Orgentec (Elisa) Thermo Scientific EliA U/mL CU/mL I.L. Acustar / INOVA Quanta Flash , e c71 v 'I' CO cr CO r- cs4 CD d d ei ei ei A Other 111 wthermo Scientitic EliA je (2>

10 ov iec A FOUNDATION T External quality Control for Assays and Tests VVith a focus on Thrombosis and Haemostasis Page 18 of 18 For any method used for the measurement of this parameter with a CV 5 7.3% the contribution of the homogeneity in this reported CV will be to large and therefore Z-scores should be interpreted with caution. See for further details page 2 of Survey Manual 218 (T17/21217PM). Several participants reported a result below the detection limit (< [value]). These results were excluded in the statistical evaluation.

11 External quality Control for Assays and Tests VVith a focus on Thrombosis and Haemostasis -1 EC AT FOUNDATION Page 16 of 18 For any method used for the measurement of this parameter with a CV 5 7.3% the contribution of the homogeneity in this reported CV will be to large and therefore Z-scores should be interpreted with caution. See for further details page 2 of Survey Manual 218 (T17/21217PM). Several participants reported a result below the detection limit (< [value]) or above the measurement range (> [value]). These results were excluded in the statistical evaluation.

12 3,ECAT External quality Control for Assays and Tests VIAth a focus on Thrombosis and Haemostasis ' FOUNDATION Page 14 of 18 For any method used for the measurement of this parameter with a CV % the contribution of the homogeneity in this reported CV will be to large and therefore Z-scores should be interpreted with caution. See for further details page 2 of Survey Manual 218 (T17/21217PM). One participant (labcode ) reported a result as ratio. This result was excluded in the statistical evaluation. Several participants reported a result below the detection limit (< [value]). These results were excluded in the statistical evaluation.

13 EC AT FOUN DAT ION Ex.temal quality Control for Assays and Tests VVith a focus on Thrombosis and Haemostasis Page 12 of 18 For any method used for the measurement of this parameter with a CV 5 7.3% the contribution of the homogeneity in this reported CV will be to large and therefore Z-scores should be interpreted with caution. See for further details page 2 of Survey Manual 218 (T17/21217PM). One participant (labcode ) reported a result as ratio. This result was excluded in the statistical evaluation. Several participants reported a result below the detection limit (< [value]), while one participant reported a result above the measurement range (> [value]). These results were excluded in the statistical evaluation.

14 AT FOUNDATION External quality Control for Assays and Tests VVIth a focus on Thrombosis and Haemostasis Page 1 of 18 Final Conclusion Final Conclusion Negative Borderline Positive No Conclusion Your Result Total Positive In total 471 participants gave a final conclusion. Fifty-nine participants (approx. 11%) gave no final conclusion. The sample used in this survey was plasma from a patient diagnosed with (LA Ratio = approx. 1.6). No other types of inhibitor were present. Of the participants who gave a final conclusion, approximately 91% classified the sample as positive. Thus, the vast majority of the participants correctly classified this sample as positive. Several participants stated that there is an indication that this sample is positive for lupus anticoagulant but in real clinical practice this should be confirmed in a new sample after 12 weeks. Some participants indicated that the presence of direct oral anticoagulants and/or an increased CRP level should be excluded. A few other participants indicated that a decreased level of some coagulation factors could be possible too.

15 c A T External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis le FOUNDATION Page 8 of 18 Assays g ce co co äddäää zother wdrvvt BAPTT SCT dpt For any method used for the measurement of this parameter with a CV 5 7.3% the contribution of the homogeneity in this reported CV will be to large and therefore Z-scores should be interpreted with caution. See for further details page 2 of Survey Manual 218 (T17/21217PM). The vast majority of the performed confirmation tests (approx. 93%) were classified as borderline or positive.

16 FOUNDATION External quality Control for Assays and Tests VVith a focus on Thrombosis and Haemostasis Page 6 of 18 Assays 21 APTT 7 DRVVT cb e V 5IIIIII!! chc& ci, 4r D C71 co Other drvvt APTT SCT daptt c<4 c\i c i A 2-1C, I I 1 IM II I II N N N cb N- CO 3 N CO Ct LC-3 CO N- CO 3 C3 d * V A BOther Siemens Pathromtin Siemens Actin FSL MOther I.L. APTT SP BStago/Roche PTT LA In Stago/Roche PTT I.L. drvv7 screen alt HemosIL SynthAsi 2-1- CO 3 CD N e e L() LO Siemens Stago/Roche A For any method used for the measurement of this parameter with a CV 5 7.3% the contribution of the homogeneity in this reported CV will be to large and therefore Z-scores should be interpreted with caution. See for further details page 2 of Survey Manual 218 (T17/21217PM). The vast majority of the performed mixing tests (approx. 84%) were classified as borderline or prolonged.

17 ilk EC A T FOUNDATION External quality Control for Assays and Tests VVith a focus on Thrombosis and Haemostasis Page 4 of 18 Assays APTT DRVVT = (..) Ot h e r SC T CO e c 6, e CO ( N co N-.7 CO co cr, d (Ni CN c MdRVVT ZdAPTT APTT, !ITT a) CO e Co co cr> e V (NCNCNCN A Li)7TAID B Other ZISiernens Pathromtin 8 M Siemens Actin FSL ZIOther INSiemens I.L. I.L. APTT SP BStago/Roche PTT LA al St a g o/roche PTT Prec Biol StagofRoche 31.L. drvvt screen B I.L. tiemosil SynthAsi For any method used for the measurement of this parameter with a CV 5 7.3% the contribution of the homogeneity in this reported CV will be to!arge and therefore Z-scores should be interpreted with caution. See for further details page 2 of Survey Manual 218 (T17/21217PM). The vast majority of performed screening tests (94%) were classified as prolonged.

18 EC A le FOUNDATION External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis Page 2 of 18 Date of lssue : Survey : 218-M2 Report : Note: In the Survey Manual 218 detailed Information is given regarding the ECAT external quality assessment programme, including the statistical evaluation and explanation of the report. This Survey Manual 218 should be considered as an integral part of this survey report. Please notice the information regarding the homogeneity of samples used and the between-laboratory variation on page 21 of the Survey Manual. General Information Complaints Any complaints regarding this survey report should be reported to the ECAT before September 14th, 218. Complaints received after this date will not be taken into consideration. P.Meijer Executive Director Note: A printed version of the actual Survey Manual is provided to all participants once a year. This manual can also be downloaded from the member section of the ECAT website. ECAT Foundation Director: Dr. P. Meijer ECAT Office P.O. Box AC Voorschoten, The Netherlands phone +31() ; fax + 31() info@ecat.n1 Website: VAT number: NL Registration number with the Chamber of Commerce (KvK) Gouda : General terms of delivery are applicable to all our services. All rights reserved. No part of this report may be reproduced, stored in a retrieval system, or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from the ECAT Foundation. Appendices are an integrel part of the total report.