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ECAT FOUNDATION INTERNATIONAL EXTERNAL QUALITY ASSESSMENT PROGRAMME IN HAEMOSTASIS AND THROMBOSIS

EXERCISE 2009-3

Page 1 of 35 Copyright © 2009 ECAT Foundation

THROMBOPHILIA MODULE LABORATORY CODE NUMBER: 900

ANTITHROMBIN

Test plasma Type of plasma Former used in exercise : : : 09.46 Plasma of a heterozygous deficient patient -

No. of Responders 277

Participation rate 89%

Outliers 0.7%

Labcode 303 , 416

CLASSIFICATION Normal 5 Borderline Normal 1 Borderline Abnormal 1 Abnormal 269 No classification 1

Method Code 101 109 155 105 106 108 112 113 114 115 117 120 121 125 126 145 150 160 110 100 123 130 135 127 128 102 103 129 140 190 199 Note:

Description Beckman Coulter Electrachrom AT Biopep Chromopep AT Biophen Antithrombin Chromogenix Coamatic Antithrombin Chromogenix Coamatic AT-400 Chromogenix Coamatic LR Antithrombin DG-Chromat ATIII Electrochem ATIII Helena Chromz-AT Hemolab ATIII chrome (Biomerieux) Hyphen-Biomed Chromopep AT I.L. HemosIL Antithrombin I.L. HemosIL liquid Antithrombin Immuno ATIII chrome Nobis Nobichrom Antithrombin Pacific Hemostasis Chrom AT assay Precision Biologic Cromocheck AT Renam Reachrom ATIII Siemens / Dade Behring Antithrombin Reagent Siemens / Dade Behring Berichrom Antithrombin III Siemens / Dade Behring Innovance Antithrombin Stago / Roche Stachrom ATIII / Antithrombin III The Binding Site AT activity Trinity / BioMerieux Chromostrate ATIII Trinity / BioMerieux MDA ATIII Trinity / Biopool Spectrolyse ATIII (anti-IIa) Trinity / Biopool Spectrolyse ATIII (anti-Xa) Trinity / Sigma Accucolor Antithrombin Unicorn ATIII Homemade Other/Unknown

Number of responders

5 22 2 6 1 1 2 9 33

3 4 77 8 96

1 1

2 4

Detailed information is given for those methods that are used by at least 10 participants.

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EXERCISE 2009-3

Page 2 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

ANTITHROMBIN (%, IU/dl)

laboratory 900 100 80 60 assay type 40 20 0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0 32.5 35.0 37.5 40.0 42.5 45.0 47.5 50.0 > 51.3 ________ chrom. a-Xa chrom. a-IIa

Count

antithrombin

.

ANTITHROMBIN Total group Chromogenic - anti-IIa Berichrom (Dade-Behring) Stachrom / ATIII (Stago/Roche) Chromogenic - anti-Xa Coamatic (Chromogenix) HemosIL liquid Antithrombin (IL) Remarks: -

n 275 180 75 96 95 22 33

mean 36.1 36.2 35.5 36.8 36.0 35.7 35.7

CV 11.2% 11.2% 9.7% 11.9% 11.2% 11.7% 10.7%

range 24 ­ 47 24 ­ 47 24 ­ 47 26 ­ 47 25 ­ 46 25 ­ 43 27 ­ 42

your result

z-score

ANTITHROMBIN ANTIGEN

No. of Responders 50 Participation rate 16% Outliers 4% Labcode 362 , 980

CLASSIFICATION Normal 1 Borderline Normal 0 Borderline Abnormal 0 Abnormal 49 No classification 0

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EXERCISE 2009-3

Page 3 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900 Method Code 1001 1002 1004 1013 1015 1009 1010 1011 1032 1028 1089 1090 1091 1092 1099 Note: Description Beckman Array AT3 Beckman Immage AT kit Coachrom ATIII EIA Helena Quickplate AT Hyphen-Biomed Liaphen ATIII Siemens / Dade Behring Human ATIII Nephelometric Siemens / Dade Behring NorPartigen Antithrombin Siemens / Dade Behring Turbiquant ATIII Stago / Roche Liatest AT The Binding Site ATIII antigen Homemade (Affinity Biologicals, antibodies) Homemade (DAKO antibodies) Homemade (Siemens / Dade Behring antibodies) Homemade (Other) Other / Unknown Number of responders

1 6 5 6 19 7 3 2 1

Detailed information is given for those methods that are used by at least 10 participants.

ANTITHROMBIN ANTIGEN (%, IU/dl)

laboratory 900

ANTITHROMBIN ANTIGEN (mg/dL)

laboratory 900 10 8 6 assay type

turb./nephelom. latex-immuno immuno-diffusion other

14 12

assay type

10 8 6 4 Count 2 0 10 15 20 25 30 35 40 45 50 55 60

________

4 2 0 10.0 11.0 12.0 > 12.5 5.0 6.0 7.0 8.0 9.0

________ turb./nephelom. immuno-diffusion

antithrombin antigen (%)

.

Count

antithrombin antigen (mg/dL)

.

ANTITHROMBIN ANTIGEN Result expressed in %

n 28

mean 38.0

CV 13.2%

Range 28 ­ 53

your result

z-score

Liatest AT (Stago)

Result expressed in mg/dL

18

18

38.9

9.4

7.6%

15.5%

33 ­ 43

6.1 ­ 11.7

Remarks:

None

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EXERCISE 2009-3

Page 4 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

PROTEIN C

Test plasma Type of plasma Former used in exercise

: : :

09.47

Coagulation Control Abnormal (Technoclone, lot no. 3P69000)

-

PROTEIN C ACTIVITY (chromogenic)

No. of Responders Participation rate Outliers Labcode

228

73%

1.8%

CLASSIFICATION

159 , 231 , 271 , 275

Normal

Borderline Normal

Borderline Abnormal

Abnormal

No classification

0

0

1

226

1

Method Code 260 206 240 205 211 212 213 216 220 246 265 202 200 226 230 223 207 204 235 290 299

Description

Beckman Coulter Electrachrom PC Biopep Chromopep PC Biophen Protein C Chromogenix Coamatic Protein C DG-Chromat PC Helena Chromz Protein C Hemolab Prot. C chrom (Biomerieux) I.L. HemosIL Protein C Immuno Prot. C chrome Precision Biologic Chromocheck Protein C Renam Reachrom Protein C Roche-Boehringer Protein C (B/M Hitachi) Siemens / Dade Behring Berichrom Protein C Stago / Roche Stachrom Protein C The Binding Site Protein C activity Trinity / BioMerieux MDA Protein C Trinity / BioMerieux Protein C chrom Trinity / Biopool Spectrolyse Protein C Unicorn Protein C Homemade Other / Unknown

Number of responders 1

7 45 1 1 16 2 4

88 56 1

6

Note:

Detailed information is given for those methods that are used by at least 10 participants.

PROTEIN C ACTIVITY (clotting)

No. of Responders Participation rate Outliers Labcode

86

28%

0%

CLASSIFICATION

-

Normal

Borderline Normal

Borderline Abnormal

Abnormal

No classification

1

0

0

83

2

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EXERCISE 2009-3

Page 5 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900 Description Number of responders 1 9 7 27 36 1 1

250 215 245 201 225 203 224 290 299

American Diagnostica Protac C I.L. HemosIL Proclot C Precision Biologic Cryocheck Clot C Siemens / Dade-Behring Protein C Reagent (coagulometric) Stago/Roche Staclot Protein C Trinity / Biopool Bioclot Protein C Trinity / Sigma Accuclot Protein C Homemade Other / Unknown

4

Note:

Detailed information is given for those methods that are used by at least 10 participants.

PROTEIN C ACTIVITY (%, IU/dl)

laboratory 900 100 80 60 40 20 0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0 32.5 35.0 37.5 40.0 42.5

laboratory 900 30

20

assay type ________ chromogenic

10

assay type ________

Count

Count

0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0 32.5 35.0 37.5 40.0 42.5

clotting

protein C chromogenic

.

protein C clotting

.

PROTEIN C ACTIVITY Chromogenic Berichrom (Dade Behring) Coamatic (Chromogenix) Prochrom C (IL) Stachrom (Stago/Roche) Clotting Dade Behring Protein C Staclot (Stago/Roche)

n 224 86 44 16 55 86 27 36

mean 25.5 26.7 23.9 23.4 25.1 28.6 30.4 30.1

CV 10.4% 9.1% 11.9% 9.3% 6.1% 18.5% 18.2% 13.0%

Range 18 ­ 34 19 ­ 34 18 ­ 34 21 ­ 29 21 ­ 29 13 ­ 42 13 ­ 42 23 - 39

your result

z-score

Remarks:

The methods for the measurement of protein C clotting activity showed a higher between-laboratory variation than the chromogenic methods.

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EXERCISE 2009-3

Page 6 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

PROTEIN C ANTIGEN

No. of Responders Participation rate Outliers Labcode

80

26%

1.3%

972

CLASSIFICATION Normal Borderline Normal Borderline Abnormal Abnormal No classification

1

0

0

79

0

Method Code 301 300 303 312 330 307 335 304 306 308 305 315 316 318 320 389 390 391 399

Description

Number of responders

Affinity Biologicals PC-EIA set Am. Diagnostica Rellplate C BioMerieux Vidas Protein C Corgenix / Reaads PC antigen DG-EIA-PC ELISARA Protein C Enzyme Research Laboratory Helena Biosciences PC Elisa Helena Protein C (Laurell) Hyphen-Biomed Zymutest Protein C Immuno Prot. C (laurell) Stago / Roche Asserachrom Protein C Stago / Roche Asseraplate Protein C Technoclone Protein C antigen The Binding Site Protein C antigen Homemade (Affinity Biological Ab) Homemade (DAKO antibodies) Homemade (other) Other / Unknown

18 8 3

6 2 1 30

3 8 1

Note:

Detailed information is given for those methods that are used by at least 10 participants.

PROTEIN C ANTIGEN (%, IU/dl)

laboratory 900 40

30

20

assay type ________

10

Count

other 0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0 32.5 35.0 37.5 40.0 42.5 ELISA

protein C antigen

.

ECAT FOUNDATION INTERNATIONAL EXTERNAL QUALITY ASSESSMENT PROGRAMME IN HAEMOSTASIS AND THROMBOSIS

EXERCISE 2009-3

Page 7 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900 PROTEIN C ANTIGEN Total group ELISA Vidas PC (Biomerieux) Asserachrom (Stago/Roche) N 78 74 18 30 Mean 25.5 25.2 25.7 24.6 CV 13.2% 12.3% 7.2% 12.8% range 17 ­ 36 17 ­ 34 22 ­ 30 20 - 32 your result z-score

Remarks:

One participant reported a result in mg/dL. This result was excluded from the statistical analysis. The between-laboratory variation for the Vidas PC method group is significantly lower in comparison to the Asserachrom method group and the whole ELISA-group.

ECAT FOUNDATION INTERNATIONAL EXTERNAL QUALITY ASSESSMENT PROGRAMME IN HAEMOSTASIS AND THROMBOSIS

EXERCISE 2009-3

Page 8 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

PROTEIN S

Test plasma Type of plasma Former used in exercise

: : :

09.48

Coagulation Control Normal (Technoclone, lot no. 1P8PAC0)

-

TOTAL PROTEIN S ANTIGEN

No. of Responders Participation rate Outliers Labcode

94

30%

2.1%

937 , 9907258

CLASSIFICATION Normal Borderline Normal Borderline Abnormal Abnormal No classification

90

2

1

1

0

Method Code

Description

Number of responders

460 450 400 417 444 412 416 403 404 406 405 420 423 427 430 489 490 491 499 Note:

Aesculisa Total Protein S Affinity Biologicals PS-EIA set American Diagnostica Rellplate S Coregenix / Reeads Total Protein S DG-EIA Prot. S total ELISARA Total Protein S Enzyme Research Laboratories Protein S kit Helena Biosciences Rocket Plate Protein S Helena Biosciences PS Elisa Hyphen Biomed Zymutest total Protein S Immuno Protein S (Laurell) Stago/Roche Asserachrom Protein S Stago/Roche Liatest Protein S Technoclone Total PS The Binding Site total PS Homemade (Affinity Biologicals Ab) Homemade (DAKO antibodies) Homemade Unknown

1

12 4 1 1 2 33 27

11 12

Detailed information is given for those methods that are used by at least 10 participants.

FREE PROTEIN S ANTIGEN

No. of Responders Participation rate Outliers 0.9% Labcode

228

73%

538 , 566

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EXERCISE 2009-3

Page 9 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900 CLASSIFICATION Normal Borderline Normal Borderline Abnormal Abnormal No classification

224

Method Code Description

0

0

2

Number of responders

2

400 401 417 418 444 445 402 411 403 404 406 407 408 405 422 423 424 431 410 489 490 491 499 Note:

Am. Diagnostica Rellplate S Chromogenix Coaliza Free Protein S Coregenix / Reeads Total Protein S Corgenix / Reeads Free Protein S DG-EIA Prot. S total DG-EIA Protein S Free Diagnostik International Free Protein S ELISARA Free Protein S Helena Biosciences Rocket Plate Protein S Helena Biosciences PS Elisa Hyphen Biomed Zymutest total Protein S Hyphen Biomed Free Protein S IL HemosIL Free Protein S Immuno Protein S (Laurell) Stago/Roche Liatest Free Protein S Stago/Roche Liatest Protein S Stago/Roche Asserachrom Free Protein S The Binding Site Free Protein S Trinity / Biopool Imulyse Free Protein S Homemade (Affinity Biologicals Ab) Homemade (DAKO antibodies) Homemade Other / Unknown

5 1 6 2 5

1 1 2 81 80 2 35 1 3 3

Detailed information is given for those methods that are used by at least 10 participants.

PROTEIN S (TOTAL AND FREE ANTIGEN) (%, IU/dl)

laboratory 900 30

laboratory 900 60 50

20

assay type ________

40 30 20

assay type ________ other LIA ELISA 60 65 70 75 80 85 90 95 100 105 110 115 120 125 128

10

other LIA

Count

60 65 70 75 80 85 90 95 100 105 110 115 120 125 > 127.5

Count

0

ELISA

10 0

total protein S

.

free protein S (% of free PS)

.

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EXERCISE 2009-3

Page 10 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

TOTAL PROTEIN S Total group ELISA

n 92 60

mean 88.4 84.3

CV 13.6% 11.2%

Range 65 ­ 125 65 ­ 110

your result

z-score

Total Protein S (Corgenix / Reeads) Asserachrom (Stago/Roche) Home made (DAKO)

LIA (Liatest (Stago/Roche))

12 33 26

26

84.0 82.9 84.0

98.4

9.8% 11.7% 5.3%

12.5%

65 ­ 99 65 ­ 109 76 - 91

78 ­ 125

Remarks:

The low between-laboratory CV for the home-made assay group is remarkable.

FREE PROTEIN S FREE PROTEIN S (% free protein S standard) ELISA

n 226 59

mean 93.5 86.4

CV 10.7% 12.6%

Range 63 ­ 125 63 ­ 125

your result

z-score

Asserachrom (Stago/Roche)

LIA

35

163

85.4

96.1

10.5%

8.6%

63 ­ 100

65 ­ 122

Free PS (I.L.) Liatest (Stago/Roche) Remarks:

80 79

95.5 96.6

9.6% 7.4%

65 ­ 122 79 - 112

The between-laboratory variation is lower for the LIA test group than for the ELISA test group.

PROTEIN S ACTIVITY

No. of Responders Participation rate Outliers Labcode

147

47%

1.4%

111 , 967

CLASSIFICATION Normal Borderline Normal Borderline Abnormal Abnormal No classification

128

8

5

5

1

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EXERCISE 2009-3

Page 11 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900 Method Code Description Number of responders

630 602 604 605 610 615 640 601 620 603 690 699 Note:

American Diagnostica Protein S Bayer Staclot Protein S Helena Protein S I.L. HemosIL ProS Nobis Protein S Precision Biologic Cryocheck Clot S Renam Protein S Siemens / Dade Behring Protein S Ac Stago / Roche Staclot Protein S Trinity / Biopool Bioclot Protein S Homemade Other / Unknown

15 5 40 85

2

Detailed information is given for those methods that are used by at least 10 participants.

PROTEIN S (ACTIVITY) (%, IU/dl)

laboratory 900 40

30

20 assay type 10

Count

________ clotting < 52.5 55 60 65 70 75 80 85 90 95 100 105 110 115

0

protein S activity

.

n PROTEIN S ACTIVITY 145

mean 79.2

CV 14.1%

Range 46 ­ 109

your result

z-score

Protein S Ac (Dade Behring) PS (I.L.) Staclot (Stago/Roche)

39 15 84

72.5 95.9 79.8

12.7% 12.7% 10.8%

57 ­ 100 66 ­ 109 46 - 101

Remarks:

-

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EXERCISE 2009-3

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Labcode: 900

APC RESISTANCE TEST

Test plasma Type of plasma Former used in exercise

: : :

09.49

Coagulation Control Normal (Technoclone, lot no. 1P8PAC0)

-

APC RESISTANCE RATIO (without Factor V deficient plasma)

No. of Responders Participation rate Outliers Labcode

59

19%

CLASSIFICATION

-

Normal

Heterozygous FV Leiden

Homozygous FV Leiden

Abnormal

No classification

55

Method Code Description

4

Number of responders

503 510 511 512 530 535 545 514 516 540 541 515 513 518 547 520 550 501 500 700 525 502 505 506 590 599

American Diagnostica APC Chromogenix / IL Coatest APC Resistance Chromogenix / IL Coatest APC Resistance V Chromogenz Inactivation Test DG-Clot aPCV Diagen PCA kit Enzyme Research Laboratories APCR Helena APC sensitivity Hemoclot Quanti Factor V-L Hyphen-Biomed APCR Hyphen-Biomed Hemoclot V-L Immunochrom APC-Response Life Diagnostics GradiLeiden V kit Pentapharm Pefakit APC-R FVL Precision Biologic CryoCheck Clot APCR REA-Clot APC-R (V) Renam APC Siemens / Dade Behring ProC Ac R Siemens / Dade Behring ProC Global / FV (with deficient plasma) Siemens / Dade Behring ProC Global Stago Staclot APC-R Trinity / Biopool Bioclot aPC sensitivity Trinity / Biomerieux Accelerimat APC Trinity / Biomerieux APCR Quick Test Homemade Other / Unknown

2 16 4

1 4 2

20 5

2

2 1

Remark: Because there are significant differences in the observed APC ratio in the different methods used by the participants we include detailed information of all different methods used. Only for those methods used by at least 10 participants a CV and Z-score was calculated. It seems that some participants their results for the APC Resistance test with the use of Factor V deficient plasma in the group of users without the use of Factor V deficient plasma.

Please notice to report your results in the correct group!

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EXERCISE 2009-3

Page 13 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

laboratory 900 14 12 10 8 6 4 assay type ________

laboratory 900 16 14 12 10 8 6 4 assay type ________ clotting 1.0 1.1 1.2 1.3 .4 .5 .6 .7 .8 .9

Count

2 0 1.50 1.75 2.00 2.25 2.50 2.75 3.00 3.25 3.50 3.75 4.00 4.25 4.50 4.75 5.00 > 5.13

Count

clotting

2 0

APC ratio

.

APC normalized ratio

.

APC ratio Total group

n 55

mean 3.23

CV 24.5%

Range 1.34 ­ 6.90

your result

z-score

APC (American Diagnostica) Coatest APCR (Chromogenix / IL) Coatest APCR-V (Chromogenix / IL) GradiLeiden V kit (Gradipore) Hemoclot V-L (HyphenBiomed) Pefakit APC-R FVL (Pentapharm) CryoCheck Clot APCR (Precision Biologic) ProC Global / FV (Siemens/Dade Behring) ProC Ac R (Siemens/Dade Behring) APCR Quick test (Trinity / Biomerieux) Bioclot APC sensitivity (Trinity / Biopool) Homemade Other

2 16 4 3 1 2

2.21 3.25 2.66 3.19 2.56 4.36 12.3%

2.01 ­ 2.40 2.57 ­ 4.00 2.26 ­ 3.10 2.75 ­ 3.81

3 89 ­ 4.82

2 20

2.50 3.26 18.4%

2.43 ­ 2.57 1.34 ­ 3.90

2 2 1

5.04 3.17 3.10

3.18 ­ 6.90 2.24 ­ 4.10

APC normalised ratio

28

0.94

16.0%

0.43 ­ 1.30

Remarks: -

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EXERCISE 2009-3

Page 14 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

APC RESISTANCE RATIO (with Factor V deficient plasma)

No. of Responders Participation rate Outliers Labcode

201

64%

0%

-

CLASSIFICATION Normal Heterozygous FV Leiden Homozygous FV Leiden Borderline No classification

194

5

2

Method Code

Description

Number of responders

503 510 511 512 530 535 545 514 516 540 541 515 513 518 547 520 550 501 500 525 502 505 506 590 599

American Diagnostica APC Chromogenix / IL Coatest APC Resistance Chromogenix / IL Coatest APC Resistance V Chromogenz Inactivation Test DG-Clot aPCV Diagen PCA kit Enzyme Research Laboratories APCR Helena APC sensitivity Hemoclot Quanti Factor V-L Hyphen-Biomed APCR Hyphen-Biomed Hemoclot V-L Immunochrom APC-Response Life Diagnostics GradiLeiden V kit Pentapharm Pefakit APC-R FVL Precision Biologic CryoCheck Clot APCR REA-Clot APC-R (V) Renam APC Siemens / Dade Behring ProC Ac R Siemens / Dade Behring ProC Global / FV (with deficient plasma) Stago Staclot APC-R Trinity / Biopool Bioclot aPC sensitivity Trinity / Biomerieux Accelerimat APC Trinity / Biomerieux APCR Quick Test Homemade Other / Unknown

6 127

2

18 2 1 21 15

1 6 2

Note:

Because there are significant differences in the observed APC ratio in the different methods used by the participants we include detailed information of all different methods used. Only for those methods used by at least 10 participants a CV and Z-score was calculated.

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EXERCISE 2009-3

Page 15 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

laboratory 900 50 40 30

laboratory 900 50 40 30

20

assay type

20

Count

10 0 < 1.625 1.75 2.00 2.25 2.50 2.75 3.00 3.25 3.50 3.75 4.00 4.25 4.50 4.75 5.00 5.25 5.50

________

assay type

Count

clotting

10 0 1.0 1.1 1.2 1.3 1.4 .4 .5 .6 .7 .8 .9

________ clotting

APC ratio (FV-def plasma)

.

APC normalized ratio (FV-def)

.

APC ratio (using FV-def. plasma) Total group

n 180

mean 2.72

CV 23.9%

Range 0.49 ­ 5.31

your result

z-score

Coatest APCR (Chromogenix / IL) Coatest APCR-V (Chromogenix / IL) APCr (ERL) APC Sensitivity (Helena) Hemoclot V-L (HyphenBiomed) Pefakit APC-R FVL (Pentapharm) CryoCheck Clot APCR (Precision Biologic) REA-clot APC-R Renam APC ProC Global (APC specific) (Siemens / Dade Behring) ProC APCR (Siemens / Dade Behring) APCR Quick test (Trinity / Biomerieux) Homemade Other

APC normalised ratio (using FV-def. plasma)

6 125

2.73 2.63 13.3%

2.25 ­ 3.10 1.60 ­ 4.90

1 18

2.12 3.89 20.3% 2.43 ­ 5.31

2

2.99

2.99 ­ 2.99

18 1 1 6 2

81

1.96 4.60 2.84 2.92 3.16

0.99

29.6%

0.49 ­ 2.60

2.10 ­ 4.20 2.81 ­ 3.50

13.1% 0.51 ­ 1.30

APC-R Stago (sec) (using FV-def. plasma)

15

168.4

9.7%

143.9 ­ 195.0

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EXERCISE 2009-3

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COAGULATION FACTOR MODULE I LABORATORY CODE NUMBER: 900

Plasmas used

:

09.54 09.55

Plasma with elevated Factor XI level Coagulation Control Borderline (Technoclone, lot. No. 1B91A00)

Former used in exercise

:

09.54 09.55

2009-2 -

Remark Sample 09.54 was the same sample as sample 09.29 in survey 2009-2. It was not meant to send this sample again. However, due to a logistic error this sample was selected for distribution again. We apologize for this mistake. Nevertheless it is interesting that again only 1/3 of the participants indicated a problem with this sample. The plasma behaves like a lupus positive sample. We have evaluated in detail the reagents used by those participants that reported a problem with this sample. The majority of those participants had used one of the following reagents: SynthAsil (IL), Actin FS (Siemens), Actin FSL (Siemens) and PTT Automate/STA APTT (Stago). This does not mean that no interference with other reagent was observed. It is not clear why the participants did not report a problem with this sample. Do these laboratories do not use multiple dilutions for factor testing? For sample 09.54 no outlier procedure was performed and no Z-score was calculated. Even the classification was not reported. Clotting Factor Sample No. of Responders Participation rate Outliers Labcode

VIII IX XI XII

09.54 09.55 09.54 09.55 09.54 09.55 09.54 09.55

194 194 181 183 173 173 174 174

92% 92% 85% 86% 82% 82% 82% 82%

1.3|%0.7% 2.1% 2.2% 1.2% 1.7%

158 , 231 , 351 , 912 158 , 324 , 351 , 397 566 , 917 125 , 351 , 952

CLASSIFICATION Clotting Factor Sample Normal Borderline Normal Borderline abnormal Abnormal No classification

VIII IX XI XII

09.54 09.55 09.54 09.55 09.54 09.55 09.54 09.55

13 52 9 42

9 29 12 21

36 30 33 33

126 66 112 72

10 6 7 6

Remarks:

Because of the borderline type of sample, sample 09.55 showed a heterogeneous pattern for the classification.

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EXERCISE 2009-3

Page 17 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

The table below shows the type activators used by the participants.

Method Code Description FVIII FIX FXI FXII

8012 8024 8026 8070 8027 8028 8029 8075 8033 8035 8030 8031 8032 8088 8034 8065 8020 8022 8021 8052 8054/8057 8058 8056 8059 8061 8062 8013 8046 8010 8047 8044 8045/8017 8014 8015 8017 8099

Axis-Shield Cephotest Diagen KPS Diagnostic Grifols APTT-L Erilyd Kaolin Helena Laboratories APTT-SA Hemoliance Synthasil APTT Hemoliance Thrombosil Hyphen Biomed Cephen 2.5 IL HemosIL APTT-HS IL HemosIL APTT lyophilised silica IL HemosIL APTT-SP liquid silica IL HemosIL APTT-SP lyophilised silica IL HemosIL Synthasil IL HemosIL SynthAsil Immuno Dapttin Pacific Hemostasis APTT-XL Siemens / Dade Behring Actin FS Siemens / Dade Behring Actin FSL Siemens / Dade Behring Pathromtin SL Sigma APTT Stago /Roche Cephalin / Kaolin - CKPrest Stago / Roche Cephascreen Stago / Roche PTT automate Stago / Roche PTT-LA Stago / Roche PTT-LT Stago / Roche STA APTT Trinity Alexin Trinity / BioMerieux Automated APTT Trinity / BioMerieux Hemolab Silimat Trinity / BioMerieux MDA / Platelin L Trinity / BioMerieux Platelin L Trinity Platelin LS / Triniclot APTT-HS Trinity / Biopool APTT-EA Trinity / Biopool APTT-P Trinity Biotech TriniClot APTT HS Other/ Unknown

1

1

1

1

1 1

1 2 13 1 15

1 2 11 1 15

1 1 2 9 1 13

1 2 10 1 12 1

24 24 21 21 2 21 1 7 4 4 4 10

23 25 23 19 3 20 1 7 4 4 4 13

22 24 21 17 3 21

24 22 20 30 14

7 4 5 3 13

3 4 4 4 14

8

6

4

5

The table below shows the methods used by the participants for the Factor VIII chromogenic assays.

Method Code Description Number of responders

8001 8002 8004 8005 8006 8003 8000 8090 8099

Chromogenix Coamatic Factor VIII Chromogenix Coatest Factor VIII Hemoliance Factor VIII Hyphen Biomed. Biophen Factor VIII Siemens / Dade Behring Technoclone Factor VIII Trinity / Biopool Spectrolyse Factor VIII:C Homemade Other / Unknown

6 2 1

1

1

Remarks:

Detailed information is given for those methods that are used by at least 10 participants.

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EXERCISE 2009-3

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Labcode: 900

Factor VIII (IU/ml /%) (Test plasma 09.54)

laboratory 900 50 40

Factor VIII (IU/ml /%) (Test plasma 09.55)

laboratory 900 70 60 50

30 20

assay type 40 ________ chromogenic 30 20

assay type ________ chromogenic two-stage one-stage 15 20 25 30 35 40 45 50 55 60 65 70 75 80

Count

Count

10 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140

two-stage one-stage

10 0

factor VIII

.

factor VIII

.

Factor VIII (plasma 09.54) total group One-stage Clotting Assay Chromogenic Activator

HemosIL APTT-SP liq. sil. (IL) HemosIL Synthasil (IL) Actin FS (Siemens) Actin FSL (Siemens ) Pathromtin SL (Siemens ) PTT Automate./STA APTT (Stago) Ceph./Kaolin - CKPrest (Stago) TriniClot APTT HS (Trinity)

n 187 171 11 n

11 15 21 23 21 20 21 10

mean 59.3 59.1 56.7 mean

54.0 51.7 38.2 64.5 62 7 56.8 73.7 81.4

CV

range 1 ­ 130 1 ­ 130 30 ­ 72

your result

z-score

CV

Range

1 ­ 89 17 ­ 100 10 ­ 82 37 ­ 105 17 ­ 89 14 ­ 130 59 ­ 110 33 ­ 120

your result

z-score

Factor VIII (plasma 09.55) total group One-stage Clotting Assay Chromogenic Activator

HemosIL APTT-SP liq. sil. (IL) HemosIL Synthasil (IL) Actin FS (Siemens ) Actin FSL (Siemens ) Pathromtin SL (Siemens) PTT Automate./STA APTT (Stago) Ceph./Kaolin - CKPrest (Stago) TriniClot APTT HS (Trinity)

n 190 173 11 N

13 15 24 23 20 21 21 10

mean 44.4 44.2 46.7 mean

45.9 44.1 43.8 41.4 41.8 47.9 45.8 42.5

CV 13.5% 13.5% 14.8% CV

13.5% 16.9% 9.1% 15.7% 15.0% 9.3% 13.2% 17.2%

Range 24 ­ 63 24 ­ 63 40 ­ 61 Range

36 ­ 56 35 ­ 63 36 ­ 56 24 ­ 54 34 ­ 62 41 - 56 32 ­ 59 29 ­ 51

your result

z-score

your result

z-score

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EXERCISE 2009-3

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Labcode: 900

Factor IX (IU/ml /%) (Test plasma 09.54)

laboratory 900 40

Factor IX (IU/ml /%)

laboratory 900 50 40

(Test plasma 09.55)

30 30 20 assay type 20 ________ 10 10 0 < 37.5 40 45 50 55 60 65 70 75 80 85 90 95 100 105 assay type ________ two-stage one-stage

Count

two-stage one-stage 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 > 205

0

Count

factor IX

.

factor IX

.

Factor IX (plasma 09.54) total group One-stage Clotting Assay Activator

HemosIL APTT-SP liq. sil. (IL) HemosIL Synthasil (IL) Actin FS (Siemens) Actin FSL (Siemens ) Pathromtin SL (Siemens ) PTT Automate./STA APTT (Stago) Ceph./Kaolin - CKPrest (Stago) TriniClot APTT HS (Trinity)

n 176 171 n

9 14 20 24 23 20 19 13

mean 116.6 116.2 mean

106.1 71.2 103.0 127.0 109.7 105.0 158.4 145.2

CV

range 0 ­ 252 0 ­ 252

your result

z-score

CV

Range

0 ­ 179 19 ­ 145 24 ­ 194 50 ­ 199 4 ­ 147 34 ­ 174 97 ­ 252 78 ­ 177

your result

z-score

Factor IX (plasma 09.55) total group One-stage Clotting Assay Activator

HemosIL APTT-SP liq. sil. (IL) HemosIL Synthasil (IL) Actin FS (Siemens) Actin FSL (Siemens ) Pathromtin SL (Siemens ) PTT Automate./STA APTT (Stago) Ceph./Kaolin - CKPrest (Stago) TriniClot APTT HS (Trinity)

n 179 173 n

11 14 23 25 21 20 19 13

mean 56.5 56.4 mean

64.1 60.5 55.4 52.2 48.4 62.0 58.1 53.1

CV 15.0% 15.1% CV

15.4% 12.7% 10.3% 13.5% 13.8% 11.0% 13.5% 13.3%

Range 34 ­ 83 34 ­ 83 Range

48 ­ 83 48 ­ 80 41 ­ 64 38 ­ 69 34 ­ 62 45 ­ 75 39 ­ 69 38 ­ 61

your result

z-score

your result

z-score

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EXERCISE 2009-3

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Labcode: 900

Factor XI (IU/ml /%) (Test plasma 09.54)

laboratory 900 30

Factor XI (IU/ml /%)

laboratory 900 60 50

(Test plasma 09.55)

20 assay type 10 ________

40 30 20 assay type ________ two-stage one-stage 15 20 25 30 35 40 45 50 55 60 65 70 75 > 77.5

Count

Count

two-stage 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 > 205 one-stage

10 0

factor XI

.

factor XI

.

Factor XI (plasma 09.54) total group One-stage Clotting Assay Activator

HemosIL APTT-SP liq. sil. (IL) HemosIL Synthasil (IL) Actin FS (Siemens) Actin FSL (Siemens ) Pathromtin SL (Siemens ) PTT Automate./STA APTT (Stago) Ceph./Kaolin - CKPrest (Stago) TriniClot APTT HS (Trinity)

n 168 164 n

7 13 20 23 21 21 17 13

mean 131.2 131.6 mean

133.3 92.2 126.7 149.2 126.8 109.1 171.9 158.1

CV

range 1 ­ 330 1 ­ 330

your result

z-score

CV

Range

1 ­ 240 33 ­ 200 31 ­ 219 78 ­ 188 2 ­ 182 19 ­ 182 107 ­ 330 91 ­ 257

your result

z-score

Factor XI (plasma 09.55) total group One-stage Clotting Assay Activator

HemosIL APTT-SP liq. sil. (IL) HemosIL Synthasil (IL) Actin FS (Siemens) Actin FSL (Siemens ) Pathromtin SL (Siemens ) PTT Automate./STA APTT (Stago) Ceph./Kaolin - CKPrest (Stago) TriniClot APTT HS (Trinity)

n 171 167 N

9 12 22 24 21 21 16 13

mean 47.2 47.1 mean

55.7 50.8 47.3 44.6 45.5 49.7 45.8 46.6

CV 15.6% 15.0% CV

14.4% 9.4% 11.7% 15.1% 23.3% 12.4% 9.3% 12.3%

Range 20 ­ 71 20 ­ 71 Range

46 ­ 68 44 ­ 59 36 ­ 58 31 ­ 59 25 ­ 71 39 - 61 39 ­ 52 37 ­ 56

your result

z-score

your result

z-score

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EXERCISE 2009-3

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Labcode: 900

Factor XII (IU/ml /%) (Test plasma 09.54)

laboratory 900 30

Factor XII (IU/ml /%)

laboratory 900 50

(Test plasma 09.55)

40 20 assay type 20 10 ________ ________

30 assay type

Count

0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200

one-stage

Count

two-stage

10 0 20 25 30 35 40 45 50 55 60 65 70 75 78

two-stage one-stage

factor XII

.

factor XII

.

Factor XII (plasma 09.54) total group One-stage Clotting Assay Activator

HemosIL APTT-SP liq. sil. (IL) HemosIL Synthasil (IL) Actin FS (Siemens) Actin FSL (Siemens ) Pathromtin SL (Siemens ) PTT Automate./STA APTT (Stago) Ceph./Kaolin - CKPrest (Stago) TriniClot APTT HS (Trinity)

n 170 164 n

10 12 21 21 20 14 30 14

mean 99.4 99.7 mean

77.2 73.2 68.4 115.9 94.7 96.5 109.4 136.4

CV

Range 0 ­ 186 0 ­ 186

your result

z-score

CV

Range

0 ­ 147 22 ­ 130 10 ­ 134 65 ­ 170 1 ­ 147 33 ­ 171 1 ­ 162 56 ­ 186

your result

z-score

Factor XII (plasma 09.55) total group One-stage Clotting Assay Activator

HemosIL APTT-SP liq. sil. (IL) HemosIL Synthasil (IL) Actin FS (Siemens) Actin FSL (Siemens ) Pathromtin SL (Siemens ) PTT Automate./STA APTT (Stago) Ceph./Kaolin - CKPrest (Stago) TriniClot APTT HS (Trinity)

n 171 165 n

10 12 24 22 20 14 30 14

mean 52.5 52.7 mean

60.6 53.9 51.7 46.3 49.1 56.6 53.9 52.8

CV 15.0% 14.5% CV

14.3% 12.2% 11.1% 10.9% 20.6% 12.8% 11.6% 11.4%

Range 26 ­ 74 30 ­ 74 Range

41 ­ 73 35 ­ 62 39 ­ 61 37 ­ 57 26 ­ 74 46 - 69 40 ­ 68 44 - 66

your result

z-score

your result

z-score

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EXERCISE 2009-3

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COAGULATION FACTOR MODULE II LABORATORY CODE NUMBER: 900

Plasmas used

:

09.56 09.57

Coagulation Control AK (Technoclone, lot no. 2B71ARV) Coagulation Control Borderline (Technoclone, lot. No. 1B91A00)

Former used in exercise

:

09.56 09.57

2009-1 -

Clotting Factor

Sample

No. of Responders

Participation rate

Outliers

Labcode

II V VII X

09.56 09.57 09.56 09.57 09.56 09.57 09.56 09.57

157 157 165 165 163 163 160 160

86% 86% 90% 90% 89% 89% 87% 87%

0.6% 0.6% 1.2% 0.6% 0.6% 0.6% 0.0% 0.0%

118 426 118 , 231 231 118 114 -

CLASSIFICATION Clotting Factor Sample Normal Borderline Normal Borderline abnormal Abnormal No classification

II V VII X

09.56 09.57 09.56 09.57 09.56 09.57 09.56 09.57

1 13 131 14 2 18 1 5

0 17 13 11 0 17 2 10

1 23 9 24 2 20 1 30

152 98 10 113 157 105 154 113

3 6 2 3 2 3 2 2

Remarks:

Sample 09.56 is classified correctly as abnormal for the clotting factors II, VII and X and normal for FV by the majority of the participants. Sample 09.57, which is a borderline sample, showed a more heterogeneous pattern.

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Labcode: 900

The table below shows the type activators used by the participants.

Method Code Description FII FV FVII FX

7030 7034 7033 7032 7035 7036 7038 7037 7031 7039 7040 7041 7045 7055 7065 7024 7025 7026 7027 7028 7029 8021 7051 7052 7053 7060 7010 7015 7011 7017 7016 7012 7013 7014 7020 7049 7048 7090 7099 Remarks:

Diamed Diaplastin E Helena Bioscience Thromboplastin Hemoliance Recomi Plastin Hemoliance Thromboplastin I.L. HemosIL PT-Fibrinogen I.L. HemosIL PT-Fibrinogen - HS I.L. HemosIL PT-Fibr.-Recombinant I.L. HemosIL Recombiplastin I.L. HemosIL Recombiplastin 2G MediRox Owren's PT Nycomed Cephotest Nycomed Nycoplastin Ortho Recombiplastin Pacific Hemostasis Thromboplastin-DS Renam Renamplastin Siemens / Dade Behring Actin FS Siemens / Dade Behring Innovin Siemens / Dade Behring Pathromtin SL Siemens / Dade Behring Thromboplastin C Plus Siemens / Dade Behring Thromborel S Siemens / Dade Behring Actin FS Siemens / Dade Behring Pathromtin SL Stago / Roche Neoplastin Ci Stago / Roche Neoplastin Ci Plus Stago / Roche Neoplastin R Technoclone Technoplastin HIS Trinity / BioMerieux Isimat 1 Trinity / BioMerieux MDA Simplastin-L Trinity / BioMerieux Nycoplastin Trinity / BioMerieux Platelin L Trinity / BioMerieux Platelin LS Trinity / BioMerieux Simplastin Excel S Trinity / BioMerieux Simplastin HTF Trinity / BioMerieux Thrombotest Trinity / Biopool Thromboplastin-S Trinity / Sigma ThromboMax HS Trinity / Sigma Thromboplastin HS Homemade Other / Unknown

2

1 1

1

1 1 2

3 1 26 2

2 1 26 2

2 2 26 2

2 25 2 1

35 1 3 27

43 1 2 27 1

41 1 2 28

37 1 2 28 1 1 44 2

43 1

46 3

1 44 2

1 1 6 1 2 1 4 1 7 1 5

1 3

1 1

1 2

1 2

Detailed information is given for those methods that are used by at least 10 participants.

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EXERCISE 2009-3

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Labcode: 900

Factor II (IU/ml /%)

laboratory 900 70 60 50 40

(Test plasma 09.56)

Factor II (IU/ml /%)

laboratory 900 80

(Test plasma 09.57)

60

assay type 30 20 ________

40

assay type ________

Count

0 8 10 12 14 16 18 20 22 24 26 28 30 > 31

clotting

Count

10

chromogenic

20 chromogenic 0 30 35 40 45 50 55 60 65 70 75 80 clotting

factor II

.

factor II

.

Factor II (plasma 09.56) Total group

n 156

mean 18.2

CV 19.7%

range 8 ­ 39

your result

z-score

Activator

n

mean

CV

Range

your result

z-score

Recombiplastin (I.L.) Innovin (Siemens) Thromborel S (Siemens) Neoplastin CI Plus (Stago)

26 35 27 42

18.8 18.5 19.0 17.9

16.4% 15.2% 21.3% 9.7%

13 ­ 28 9 ­ 23 11 ­ 27 14 ­ 22

Factor II (plasma 09.57) Total group

n 156

mean 49.8

CV 10.5%

Range 35 ­ 66

your result

z-score

Activator

N

mean

CV

Range

your result

z-score

Recombiplastin (I.L.) Innovin (Siemens) Thromborel S (Siemens) Neoplastin CI Plus (Stago)

26 35 27 43

51.3 49.7 49.7 50.0

11.6% 10.5% 10.6% 8.0%

37 ­ 63 41 ­ 66 39 ­ 64 42 - 63

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Labcode: 900

Factor V (IU/ml /%)

laboratory 900 60 50 40 30 20

(Test plasma 09.56)

Factor V (IU/ml /%)

laboratory 900 60 50 40 30 assay type ________ clotting 20

(Test plasma 09.57)

assay type ________ clotting 30 35 40 45 50 55 60 65 70 75 80

Count

10 0 50 55 60 65 70 75 80 85 90 95 100 > 102.5

Count

10 0

factor V

.

factor V

.

Factor V (plasma 09.56) Total group

n 163

mean 75.8

CV 9.8%

range 57 ­ 99

your result

z-score

Activator

n

mean

CV

Range

your result

z-score

Recombiplastin (I.L.) Innovin (Siemens ) Thromborel S (Siemens) Neoplastin CI Plus (Stago)

26 43 27 45

76.5 79.1 76.1 73.0

8.7% 9.2% 10.5% 8.3%

62 ­ 90 65 ­ 99 62 ­ 94 57 ­ 87

Factor V (plasma 09.57) Total group

n 164

mean 47.7

CV 11.2%

Range 35 ­ 62

your result

z-score

Activator

n

mean

CV

Range

your result

z-score

Recombiplastin (I.L.) Innovin (Siemens) Thromborel S (Siemens) Neoplastin CI Plus (Stago)

26 43 27 46

46.2 50.7 49.3 45.2

11.4% 9.0% 9.7% 9.6%

38 ­ 58 41 ­ 62 41 ­ 59 35 - 55

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EXERCISE 2009-3

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Labcode: 900

Factor VII (IU/ml /%) (Test plasma 09.56)

laboratory 900 50 40 30 assay type 20 10 0 15.0 17.5 20.0 22.5 25.0 27.5 30.0 32.5 35.0 37.5 40.0 42.5 > 43.8

Factor VII (IU/ml /%)

laboratory 900 60 50 40 30 ________ 20

(Test plasma 09.57)

assay type ________ chromogenic clotting 20 25 30 35 40 45 50 55 60 65 70

Count

chromogenic clotting

Count

10 0

factor VII

.

factor VII

.

Factor VII (plasma 09.56) Total group

n 162

mean 27.0

CV 14.4%

range 17 ­ 40

your result

z-score

Activator

n

mean

CV

Range

your result

z-score

Recombiplastin (I.L.) Innovin (Siemens) Thromborel S (Siemens) Neoplastin CI Plus (Stago)

26 41 28 43

25.2 28.7 24.6 27.7

15.8% 11.0% 14.8% 9.2%

18 ­ 40 22 ­ 34 17 ­ 33 22 ­ 32

Factor VII (plasma 09.57) Total group

n 162

mean 49.7

CV 11.7%

Range 33 ­ 67

your result

z-score

Activator

n

mean

CV

Range

your result

z-score

Recombiplastin (I.L.) Innovin (Siemens ) Thromborel S (Siemens ) Neoplastin CI Plus (Stago)

26 41 27 44

45.3 50.0 51.2 51.4

11.6% 9.5% 11.9% 7.3%

35 ­ 61 42 ­ 60 41 ­ 67 43 - 58

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EXERCISE 2009-3

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Labcode: 900

Factor X (IU/ml /%)

laboratory 900 80

(Test plasma 09.56)

Factor X (IU/ml /%)

laboratory 900 70 60

(Test plasma 09.57)

60

50 40 assay type ________ ________ 20

40

assay type

30

Count

20

Count

chromogenic 0 4 6 8 10 12 14 16 18 20 22 > 23 clotting

10 0 25 30 35 40 45 50 55 60 65 70 > 72.5

chromogenic clotting

factor X

.

factor X

.

Factor X (plasma 09.56) Total group

n 158

mean 11.0

CV 23.4%

range 6 ­ 27

your result

z-score

Activator

n

mean

CV

Range

your result

z-score

Recombiplastin (I.L.) Innovin (Siemens / DB) Thromborel S (Siemens / DB) Neoplastin CI Plus (Stago/Roche)

25 37 28 43

11.9 10.3 11.5 10.3

20.2% 21.4% 23.0% 10.5%

10 ­ 22 7 ­ 21 7 ­ 18 8 ­ 13

Factor X (plasma 09.57) Total group

n 158

mean 48.0

CV 9.5%

Range 32 ­ 65

your result

z-score

Activator

n

mean

CV

Range

your result

z-score

Recombiplastin (I.L.) Innovin (Siemens / DB) Thromborel S (Siemens / DB) Neoplastin CI Plus (Stago/Roche)

25 37 28 44

48.4 49.3 47.4 47.4

9.9% 9.4% 10.1% 7.4%

38 ­ 60 40 ­ 65 32 ­ 57 40 ­ 56

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EXERCISE 2009-3

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von WILLEBRAND FACTOR LABORATORY CODE NUMBER: 900

Test plasma Type of plasma

: :

09.58

Coagulation Control Abnormal (Technoclone, lot no. 3P69000) (mimicking a VWD type I patient)

Former used in exercise

:

-

Test

vWF:Ag vWF:RiCoF vWF:CBA vWF Multimers FVIII:C

No. of Responders 204

Participation rate 90%

Outliers

Labcode

1.0% 1.1% 2.0% 1.7%

426 , 916 466 , 583 932 188 , 247 , 388

187 50 35 178

82% 22% 15% 78%

Normal

vWF:Ag vWF:RiCoF vWF:CBA FVIII:C

1 0 1 2

Borderline Normal 1

CLASSIFICATION Borderline abnormal 6

Abnormal

194 184 49 169

No classification 2

0 0 0

0 0 2

3 0 5

vWF antigen Method Code 6000 6001 6002 6004 6045 6015 6018 6035 6037 6036 6005 6038 6030 6040 6020 6023 6010 6050 6090 6091 6099 Description Number of responders

ABP vWF assay American Diagnostica Rellplate vWF American Diagnostica Immunobind vWF BioMerieux Vidas vWF Corgenix / Reaads vWF antigen DG-EIA vWF ELISARA Von Willebrand Grifols DG-EIA vWF Helena Laboratories Rocket vWF Ag Helena Laborarories vWF AG I.L. / Chromogenix vWF IMTEC vWF Life Daignostics vWF EIA Ramco Laboratories Spectra vWF Roche / Stago Asserachrom vWF Roche / Stago Liatest vWF Siemens / Dade Behring vWF Technoclone vWF Ag Homemade (DAKO antibodies) Homemade (Other) Other/ Unknown

1 1 17 1 3 4 1 1 30

1 6 80 39 14 2 3

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EXERCISE 2009-3

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Labcode: 900 vWF:RiCoF / Activity Method Code 6100 6101 6102 6105 6135 6108 6115 6120 6125 6130 6140 6110 6107 6190 6199 Description Number of responders

ABP vWF assay American Diagnostica vWF RiCoF Elisa Axis-Shield vWFactivity assay Biodata vWF assay Corgenix / Reaads vWF activity Chronolog vWF assay DG vWF activity Hart Biological vWF assay Helena Laboratories vWF RiCoF assay IL Latex vWF activity Shield Diagnostics vWF RiCoF assay Siemens / Dade Behring vWF Reagent Trinity / Biopool vWF RiCoF assay Homemade Other/ Unknown

3 1 5 5 1 7 1 1 8 44 100 1 9 1

vWF:CBA Method Code 6205 6210 6220 6225 6215 6240 6245 6250 6290 6291 6299 Description Number of responders

Corgenix / Reaads CBA DG CBA EIA Immunozym vWF:CBA assay Inadipore vWF:CBA assay Life Diagnostics vWF:CBA assay Progen vWF: CB Elisa Roche / Stago Asserachrom vWF:CBA Tecnoclone vWF:CBA assay Homemade (DAKO antibodies) Homemade (Other) Other/ Unknown

14 2 4 20 9 1

Note:

Detailed information is given for those methods that are used by at least 10 participants.

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EXERCISE 2009-3

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Labcode: 900

vWF antigen

laboratory 900

vWF:RiCoF / vWF Activity

laboratory 900

120 100 80 60 40 Count 20 0 15 20 25 30 35 40 45 50 55 60 65

assay type ________

80

assay type ________

60

40

ELFA other LIA ELISA

other activity

20 Count

Aggregation

0 5 10 15 20 25 30 35 40 45 50

Agglutination

vWF:RiCoF

vWF antigen

.

.

vWF antigen total group ELISA

n 202 32

mean 34.3 32.9

CV 11.6% 15.3%

range 23 ­ 46 23 ­ 46

your result

z-score

Home-made (DAKO)

ELFA

14

31.7

12.5%

24 - 40

Vidas vWF (bioMerieux)

LIA

17

151

37.9

34.1

7.0%

10.3%

33 ­ 44

23 ­ 42

Coamatic vWF (Chromogenix) vWF (Siemens / DB) Liatest vWF (Stago)

30 39 79

34.6 31.5 35.2

8.8% 11.4% 8.5%

26 ­ 41 23 ­ 41 26 ­ 42

vWF:RiCoF / Activity total group vWF:RiCoF Agglutination

n 185

mean 26.8

CV 18.7%

range 16 ­ 42

your result

z-score

104

25.3

16.9%

16 ­ 42

vWF Reagent (Siemens / DB)

Aggregation vWF Activity Latex Immunoassay

98

20

25.3

27.5

16.9%

22.2%

16 ­ 42

19 ­ 42

49

28.7

15.7%

19 ­ 39

Latex vWF activity (IL)

Other assays

44

12

29.2

31.3

14.8%

19.5%

21 - 39

19 ­ 42

ECAT FOUNDATION INTERNATIONAL EXTERNAL QUALITY ASSESSMENT PROGRAMME IN HAEMOSTASIS AND THROMBOSIS

EXERCISE 2009-3

Page 31 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

vWF:CBA

laboratory 900 30

20

10

assay type ________

Count

0 10 15 20 25 30 35 40 45 50 55 60

ELISA

vWF:CBA

.

vWF:CBA total group 49

mean 29.1

CV 18.9%

range 17 ­ 39

your result

z-score

vWF:CBA assay (Life Diagnostics) vWF:CBA assay (Technoclone) Homemade

13 20 9

26.5 31.3 27.2

26.9% 13.4% 14.6%

17 ­ 39 24 ­ 38 20 - 34

vWF Multimers

Normal distribution Lack of MMW and HMW Lack HMW Undetectable Borderline

30 5 -

Remark:

Some participants reported a slight lack of HMW multimers which could be the result of the lyophilisation process of the plasma.

ECAT FOUNDATION INTERNATIONAL EXTERNAL QUALITY ASSESSMENT PROGRAMME IN HAEMOSTASIS AND THROMBOSIS

EXERCISE 2009-3

Page 32 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

FVIII:C

laboratory 900 80

29

60

40 assay type 20

Count

________ all assays 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0 32.5 35.0 37.5 40.0 42.5 > 43.8

0

FVIII:C

.

FVIII:C (%, IU/dL) total group

N 175

mean 21.6

CV 19.6%

range 8 - 40

your result

z-score

INTERPRETATION

Ratio vWF:RiCoF / vWF antigen

<< 1 <1 ~1 >1

Ratio Factor VIII / vWF antigen

<< 1 <1 ~1 >1

FINAL CONCLUSION

10 70 65

14 93 34 3

No conclusion Normal Type 1 Type 2A Type 2B Type 2M Type 2N Type 3 Nothing indicated

49 1 93 5 1 2 2 1 50

Your conclusion:

Comment :

-

ECAT FOUNDATION INTERNATIONAL EXTERNAL QUALITY ASSESSMENT PROGRAMME IN HAEMOSTASIS AND THROMBOSIS

EXERCISE 2009-3

Page 33 of 35 Copyright © 2009 ECAT Foundation

FACTOR XIII LABORATORY CODE NUMBER: 900

Plasmas used

:

09.61 09.62

Coagulation Control Abnormal (Technoclone, lot no. 3P69000) Sample with Factor XIII level of 2 ­ 3%

Former used in exercise

:

09.61 09.62

2009-2

ACTIVITY - QUALITATIVE

Sample

09.61 09.62

No. of Responders 30 29

Participation rate 36% 35%

Overview of the combinations of activator and lysis agents used Activator Lysis agent

Thrombin (human) 0 0 2

Thrombin (bovine) 1 2 2

Calcium Chloride 2 3 15

Acetic acid Chloro-acetic acid Urea

Agkistrodon rhodastoma venom 0 0 1

RESULTS

There was some confusion about the manner we have asked for reporting the result for the Factor XIII qualitative assay. Some laboratories only reported yes or no lysis or normal vs abnormal. In our report form we ask for negative, which means Factor XIII undetectable, or positive, which means Factor XIII detectable, including a grading for positivity. Because several participants had indicated that they interpret negative as normal it was difficult to evaluate the category "negative". We highly recommend for future surveys to interpret the result according as indicated above. Negative = no Factor XIII activity or undetectable activity Positive = detectable Factor XIII activity

Negative Sample 09.61 Sample 09.62

Positive (+)

Positive (++)

Positive (+++)

Your result

10 10

3 8

9 7

8 4

ECAT FOUNDATION INTERNATIONAL EXTERNAL QUALITY ASSESSMENT PROGRAMME IN HAEMOSTASIS AND THROMBOSIS

EXERCISE 2009-3

Page 34 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

ACTIVITY - QUANTITATIVE

No. of Responders 40 40 Participation rate 48% 48%

Sample

Outliers

Labcode

09.61 09.62

2.5% 0.0%

CLASSIFICATION Borderline abnormal 0 0

512 -

Sample

Normal

09.61 09.62

1 0

Borderline Normal 0 0

Abnormal

37 37

No classification 2 3

Method Code 4010 4015 4020 4025 4099

Description

Number of responders

Siemens / Dade Behring Stago Factor XIII Technoclone Technochrom FXIII Pentepharm Pefakit FXIII Unknown

37 1 1 1 0

Note:

Detailed information is given for those methods that are used by at least 10 participants.

Factor XIII (IU/ml /%) (Test plasma 09.61)

laboratory 900 30

Factor XIII (IU/ml /%)

laboratory 900 10 8

(Test plasma 09.62)

20 6 4 2 0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0

10

assay type ________

assay type ________ chromogenic

Count

0 > 42.5 10 15 20 25 30 35 40

chromogenic

Count

Factor XIII activity

.

Factor XIII activity

.

FACTOR XIII (sample 09.61) Total group

n 40

mean 31.5

CV 21.0%

range 9 ­ 52

your result

z-score

Berichrom (Siemens / Dade Behring)

37

n 36

31.3

mean 13.0

21.3%

CV 56.8%

9 - 52

range 1 ­ 29 your result z-score

FACTOR XIII (sample 09.62) Total group

Berichrom (Siemens / Dade Behring)

32

13.7

51.1%

1 - 29

ECAT FOUNDATION INTERNATIONAL EXTERNAL QUALITY ASSESSMENT PROGRAMME IN HAEMOSTASIS AND THROMBOSIS

EXERCISE 2009-3

Page 35 of 35 Copyright © 2009 ECAT Foundation

Labcode: 900

ANTIGEN

No. of Responders 16 16 Participation rate 19% 19%

Sample

Outliers

Labcode

09.61 09.62

0.0% 6.3%

CLASSIFICATION Borderline abnormal 1 0

321

Sample

Normal

09.16 09.17

0 0

Borderline Normal 1 0

Abnormal

14 16

No classification 0 0

Method Code 4301 4305 4310 4330 4315 4390

Description

Number of responders

Affinity Biologicals Factor XIII The Binding Site Factor XIII I.L. HemosIL Factor XIII MBL Hexamate Factor XIII Reanal-Ker Factor XIII Elisa Homemade

3 1 7 3 1 1

Note: Two participants had reported a result expressed in mg/L. These results were not included in the statistical evaluation.

Factor XIII (IU/ml /%) (Test plasma 09.61)

laboratory 900 10

Factor XIII (IU/ml /%)

laboratory 900 8

(Test plasma 09.62)

8

6

6 4 assay type

4 assay type 2

Count

2 0 10 15 20 25 30 35 40 45 48

________ all assays

Count

________ 0 1 2 3 4 5 6 7 > 7.5 all assays

Factor XIII antigen

.

Factor XIII antigen

.

FACTOR XIII (sample 09.61) Total group

n 16 n 15

mean 35.9 mean 3.3

CV 34.0% CV 53.3%

range 3 - 65 range 0-6

your result

z-score

FACTOR XIII (sample 09.62) Total Group

your result

z-score

Information

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