ECAT FOUNDATION External quality Control for Assays and Tests

ECAT FOUNDATION External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

REPORT

SURVEY 2013-2 Thrombin Generation Test Labcode 9000

Copyright © 2013 ECAT Foundation

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Survey: 2013-2 Page 2 of 12 24-July-2013 Labcode:

Date of Issue

:

24-July-2013

Survey

:

2013-2

Report

:

Thrombin Generation Test

9000

Note: In the Survey Manual 2013 detailed information is given regarding the ECAT external quality assessment programme, including the statistical 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 participating 46 laboratories in the Thrombin Generation Test module. The participation rate in this survey was 65%.

P.Meijer Executive Director

Note: A printed version of the Survey Manual 2013 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 30 2300 AA LEIDEN, The Netherlands phone ++31.88 86 69 718: fax ++ 31.88 86 68 965 E-mail: [email protected] Website: www.ecat.nl VAT number: NL802836872B01

Registration number with the Chamber of Commerce (KvK) Gouda : 41174102 All the usual conditions are applicable to all our services

All rights reserved. No part of this report may be reproduced, stored in a retrieval system, or transmitted in any form or by means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from the ECAT Foundation. Appendixes are an integral part of the total report.

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Survey: 2013-2 Page 3 of 12 24-July-2013 Labcode:

9000

Thrombin Generation Test No. of Responders

45

Sample No Sample Details

13.57 Normal Coagulation Control Plasma Prior Use: None

Stability

31-December-2013

Homogeneity

1.80 %

Sample No Sample Details

13.58 Abnormal Coagulation Control Plasma Prior Use: None

Stability

30-June-2014

Homogeneity

2.20 %

Sample No Sample Details

13.59 Plasma of a patient with Haemophilia B (FIX level < 10%) Prior Use: None

Stability

25/07/2013 00:00:00

Homogeneity

4.30 %

Comments

For all different methods a siginificant decrease of the thrombin generation was observed in the Abnormal Coagulation Control sample (sample 13.58) with respect to the Normal Coagulation Control sample (sample 13.57). In an Abnormal Coagulation Control sample all coagulation factors are decreased to approx. half of the concentration in a Normal Coagulation Control sample. For the plasma of a Haemophilia B patient (FIX level < 10%) a more heterogeneous pattern was observed. For most of the methods the thrombin generation was only slightly decreased (approx. 10%). However, with the TGA method (Techncolone), using reagent CLow, the thrombin generation was approx. 20% decreased, while for the CAT method (Trombinoscope), using 1 pM tissue factor the decrease was approx. 55%.

Survey: 2013-2

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Page 4 of 12 24-July-2013 Labcode:

Thrombin Generation Test

9000

ETP assay (Siemens/DB)

Sample 13.57 Innovin (pipette scheme A) Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) ETP

Number 1 1 3 3

Target Value 32.7 97.7 107 83

CV (%)

Range

Your Result

Number

Target Value

CV (%)

Range

Your Result

Number

Target Value

CV (%)

Range

Your Result

1 1

90 101

Number 1 1 3 3

Target Value 122.1 262.1 19 17

CV (%)

Range

Your Result

Number

Target Value

CV (%)

Range

Your Result

Number

Target Value

CV (%)

Range

Your Result

1 1

17 17

96 - 121 75 - 107

Innovin (pipette scheme B) Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) ETP

Actin FS/Innovin (pipette scheme C) Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) ETP Sample 13.58 Innovin (pipette scheme A) Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) ETP

18 - 37 16 - 20

Innovin (pipette scheme B) Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) ETP

Actin FS/Innovin (pipette scheme C) Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) ETP

Survey: 2013-2

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Page 5 of 12 24-July-2013 Labcode:

Thrombin Generation Test

9000

ETP assay (Siemens/DB)

Sample 13.59 Innovin (pipette scheme A) Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) ETP

Number 1 1 3 3

Target Value 36.1 97.8 86 80

CV (%)

Range

Your Result

Number

Target Value

CV (%)

Range

Your Result

Number

Target Value

CV (%)

Range

Your Result

1 1

83 88

84 - 111 78 - 89

Innovin (pipette scheme B) Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) ETP

Actin FS/Innovin (pipette scheme C) Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) ETP

Survey: 2013-2

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Page 6 of 12 24-July-2013 Labcode:

Thrombin Generation Test

9000

Pefakit TDT (Pentapharm)

Sample 13.57 Standard Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Number

Target Value

1 1 1

68.8 2657 94.4

Number

Target Value

1 1 1

122.3 1058 37.6

Number

Target Value

1 1 1

94.8 2423 86.1

CV (%)

Range

Your Result

CV (%)

Range

Your Result

CV (%)

Range

Your Result

Sample 13.58 Standard Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Sample 13.59 Standard Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Survey: 2013-2

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Page 7 of 12 24-July-2013 Labcode:

Thrombin Generation Test

9000

TGA (Technoclone)

Sample 13.57 Reagent B Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Number 3 3 3 3 3

Target Value 10.0 15.9 186 26.5 2083

CV (%)

Range 7.5 - 30.5 13.7 - 39.5 164 - 191 21.1 - 32.4 2056 - 3361

Your Result

Number 5 5 5 5 5

Target Value 12.8 19.1 220 36.8 2503

CV (%)

Range 2.8 - 17.9 10.4 - 23.9 113 - 269 14.8 - 44.9 1883 - 3749

Your Result

Number 3 3 3 3 3

Target Value 3.0 8.0 233 46.5 2110

CV (%)

Range 2.5 - 3.5 7.7 - 8.1 226 - 359 43.9 - 86.0 1967 - 2137

Your Result

Number 3 3 3 3 3

Target Value 15.2 25.1 49 5.0 902

CV (%)

Range 10.4 - 65.5 19.0 - 79.5 28 - 59 2.1 - 7.0 664 - 1093

Your Result

Number 5 5 5 5 5

Target Value 19.1 25.1 53 6.3 1084

CV (%)

Range 2.6 - 32.4 9.2 - 44.6 24 - 67 2.0 - 10.1 414 - 1234

Your Result

Number 3 3 3 3 3

Target Value 2.6 7.0 101 27.8 1127

CV (%)

Range 2.2 - 3.8 5.8 - 9.0 83 - 120 15.8 - 28.0 1036 - 1500

Your Result

Reagent Clow Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Reagent Chigh Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Sample 13.58 Reagent B Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Reagent Clow Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Reagent Chigh Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Survey: 2013-2 Page 8 of 12 24-July-2013 Labcode:

Thrombin Generation Test

9000

TGA (Technoclone)

Sample 13.59 Reagent B Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Number 3 3 3 3 3

Target Value 15.2 24.5 81 7.5 1916

CV (%)

Range 8.1 - 36.5 13.4 - 52.5 71 - 207 5.0 - 39.7 1115 - 2084

Your Result

Number 5 5 5 5 5

Target Value 10.0 16.6 150 24.0 2025

CV (%)

Range 3.7 - 20.0 10.0 - 29.0 52 - 372 4.4 - 108.4 1164 - 3324

Your Result

Number 3 3 3 3 3

Target Value 3.5 10.2 199 32.3 2082

CV (%)

Range 2.8 - 4.3 7.7 - 10.5 121 - 268 16.4 - 66.9 1608 - 2307

Your Result

Reagent Clow Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Reagent Chigh Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Survey: 2013-2

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Page 9 of 12 24-July-2013 Labcode:

Thrombin Generation Test

9000

CAT (Thrombinoscope)

Sample 13.57 TF: 1 pM Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Number 15 15 15 11 15

Target Value 4.9 9.3 207 46.0 1520

CV (%) 23.7 13.4 24.3 15.7 18.5

Range 3.1 - 7.8 5.9 - 11.8 118 - 405 28.5 - 82.0 898 - 2106

Your Result

Number 20 20 20 14 20

Target Value 3.2 7.7 229 48.6 1676

CV (%) 12.9 13.8 22.3 29.1 17.1

Range 2.0 - 4.3 3.8 - 10.2 145 - 428 30.5 - 75.5 1276 - 2519

Your Result

Number 2 2 2 1 2

Target Value 6.7 9.2 319 84.4 1549

CV (%)

Range 1.7 - 11.8 3.3 - 15.0 272 - 366

Your Result

Number 15 15 15 11 15

Target Value 4.7 10.5 56 10.4 685

CV (%) 20.2 12.8 23.2 38.2 12.5

Range 2.3 - 7.8 4.5 - 12.2 41 - 84 7.0 - 46.7 544 - 961

Your Result

Number 20 20 20 14 20

Target Value 2.6 5.3 82 31.6 753

CV (%) 14.6 11.5 11.3 15.9 13.7

Range 2.1 - 3.7 4.2 - 6.3 69 - 108 21.3 - 37.4 620 - 1152

Your Result

Number 2 2 2 1 1

Target Value 26.1 30.7 62 5.0 667

CV (%)

Range 3.0 - 49.1 4.9 - 56.4 37 - 87

Your Result

TF: 5 pM Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Other Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

1524 - 1574

Sample 13.58 TF: 1 pM Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP TF: 5 pM Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Other Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Survey: 2013-2

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Page 10 of 12 24-July-2013 Labcode:

Thrombin Generation Test

9000

CAT (Thrombinoscope)

Sample 13.59 TF: 1 pM Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Number 15 15 15 11 15

Target Value 5.5 11.2 81 15.9 853

CV (%) 36.4 24.7 68.7 73.9 36.6

Range 2.3 - 10.2 7.4 - 16.6 13 - 214 5.0 - 56.7 187 - 1611

Your Result

Number 20 20 20 14 20

Target Value 2.7 7.0 159 35.4 1373

CV (%) 12.8 10.2 30.9 31.2 16.8

Range 2.0 - 3.3 5.6 - 8.7 92 - 348 17.0 - 72.0 827 - 2325

Your Result

Number 1 1 1 1

Target Value 60.3 65.1 44 9.2

CV (%)

Range

Your Result

TF: 5 pM Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Other Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Survey: 2013-2

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Page 11 of 12 24-July-2013 Labcode:

Thrombin Generation Test

9000

Homemade

Sample 13.57 Assay Variant 1 Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Number 1 1 1

Target Value 2.5 8.5 249

CV (%)

Range

Your Result

1

2255

Number

Target Value

CV (%)

Range

Your Result

Number

Target Value

CV (%)

Range

Your Result

Number 1 1 1

Target Value 3.0 9.0 57

CV (%)

Range

Your Result

1

767

Number

Target Value

CV (%)

Range

Your Result

Number

Target Value

CV (%)

Range

Your Result

Assay Variant 2 Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Assay Variant 3 Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Sample 13.58 Assay Variant 1 Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Assay Variant 2 Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Assay Variant 3 Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Survey: 2013-2

External quality Control for Assays and Tests With a focus on Thrombosis and Haemostasis

Page 12 of 12 24-July-2013 Labcode:

Thrombin Generation Test

9000

Homemade

Sample 13.59 Assay Variant 1 Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP

Number 1 1 1

Target Value 3.0 11.0 76

CV (%)

Range

Your Result

1

1408

Number

Target Value

CV (%)

Range

Your Result

Number

Target Value

CV (%)

Range

Your Result

Assay Variant 2 Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP Assay Variant 3 Parameter Lag phase (sec) Time-to-peak (sec) Peak thrombin (nM) Velocity Index ETP