ECAT FOUNDATION REPORT SURVEY 2013-1 Lupus ... - LKF-Kiel

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

REPORT

SURVEY 2013-1 Lupus Anticoagulant Labeode 9907152

Copyright @ 2013 ECAT Foundation

E(AT

Survey: 2013-1

Externa! qua!ity Contra! for Assays and Tests With a foeus on Thrambosis and Haemostasis

Page 3 of 18 04-June-2013

FOUNDATION

Labcode:

I Lupus Anticoagulant

9907152

I I Screening

No. of Responders

228 Sam pie No Sam pie Details

13.07 Normal pooled plasma enriched with approx. 200 ng/mL Rivaroxaban Units: Ratio Prior Use: None

Stability

31-December-2015

Homogeneity

0.80 %

Assay

Normal

APTT dAPTT dPT dRWT KCT Other PNP PT SCT

9 0 2 1 1 0 0 0 1

Ratio

Borderline

Prolonged

259 20 5 318 15 2 1 4 30

5 0 0 3 0 0 0 0 0

n

assigned value

CV (%l

3 0 0 4 0 0 0 0 3

range

250

1.60

12.0

0.83 - 3.35

SP

35

1.65

11.8

1.30 - 1.89

I.L. HemoslL SynthAsil

14

1.42

7.2

1.18 - 1.56

I.L. MixCon

7

1.32

36

1.50

11.4

0.83-1.78

9.3

1.23 - 2.18

APTI I.L. APTI

Siemens Actin FSL SL

21

1.79

APTI-Kaolin

7

1.68

StagolRoche

PTI

22

1.57

6.4

1.14 - 1.79

Stago/Roche

PTI LA

65

1.60

7.1

1.11 - 1.99

7

1.65

10

1.71

8.7

1.50 - 1.96

18

1.69

16.4

1.26 - 2.33

9

1.67

7

1.39

292

2.28

6

2.42

Trinity Biotech Automated

APTI

Trinity Biotech TriniClot APTI-HS dAPTI Stago/Roche

PTI LA

dPT dRWT American

Diagnostics

DWconfirm

American Diagnostics I.L. HemoslL dRWT

DWtest screen

I.L. LAC screen Life Diagnostics

LA screen

1.20 - 4.38

13

2.19

15.1

1.20 - 2.72

38

2.14

10.7

1.73 - 4.38

30

2.33

10.2

1.55 - 2.82

15

2.47

7.9

2.09 - 3.14

2.04

16.3

1.47-2.44

5.9

1.43 - 2.92

56

2.23

7.0

1.53 - 2.69

Life Diagnostic Kaoclot SCT I.L. SCT screen

8

2.47

13

2.09

panel 2

z-score

2.65

1.69

2.49

0.95

2.65

2.40

1.25 - 3.52

2.32

LA Screen

z-score

1.08 - 1.89 9.6

16

Technoclone

Prolonged

1.44 - 1.76

99

KCT

Prolonged

1.57 - 1.71

Precision Biologie LA check screen

Screening 2

1.58 -1.94

Siemens LA1 screen Stago / Roche DRWT

panel 1

Screening 1

1.01 - 1.38

Stago/Roche

Siemens Pathromtin

Your result

No Classification

2.01 - 2.71 26.7

1.22 - 3.17

5

2.10

31

1.55

11.5

1.89 - 3.17 1.25 - 2.74

29

1.53

10.4

1.25 - 1.81

2.49

Screening 3

panel 3

z-score

ECAT

Survey: 2013-1



FOUNDATION

Labeode:


11

9907152

Mixing

No. of Responders 159

Sam pie No Sam pie Details


Stability

31-December-2015

Homogeneity

0.80 %

Normal

Assay

Borderline

Prolonged

Your result

No Classification Mixing 1

APTT dAPTT dPT dRWT KCT PT SCT

38 2 1 1 7 0 4

22 0 1 4 3 0 2

assigned value

CV (%)

range

200

130

6.6

0.94 - 203

27

1.32

6.6

1.15-1.52

I.L. HemoslL SynthAsil

11

1.23

4.2

1.16 - 1.29

I.L. MixCon

5

1.06

27

1.26

7.6

1.06 - 1.69

APTT I.L. APD

SP

Siemens Actin FSL Siemens Pathromtin Stago/Roche

PD

Stago/Roche

PD

SL

LA

Trinity Biotech Automated

APD

Trinity Biotech TriniClot APD-HS dAPTT Stago/Roche

PD

LA

dPT

1.03 - 1.60

18

1.38

5.3

1.29 - 1.49

18

1.27

2.7

0.97 - 1.47

56

1.30

4.6

0.94 - 1.51

7

1.31

8

1.33

22

1.34

7.0

11

1.31

4.1

7

1.27

1.28 - 1.36 1.19 - 1.42 1.16 -1.51 1.24 - 1.48 0.94 - 2.03 9.5

1.27 - 2.81

187

1.76

DWconfirm

6

1.76

DWtest

7

1.73

15

1.68

9

1.78

12

1.76

12.5

Precision Biologie LA check

10

1.65

15.4

1.29-1.94

Siemens LA1 screen

75

1.78

7.9

1.27 - 2.26

38

1.78

9.6

1.29 - 2.04

17

1.26

13.3

0.69 - 3.17

dRWT American

Diagnostics

American Diagnostics I.L. HemoslL dRWT

screen

I.L. LAC screen Life Diagnostics

LA screen

Stago / Roche DRWT KCT Life Diagnostic SCT I.L. SCT screen

Kaoclot

screen

1.52 - 2.81 1.43 - 1.86 10.4

Mixing 3

4 0 0 5 0 0 0

151 21 5 187 8 3 9

n

Ratio

Mixing 2

1.27 - 1.93 1.61 - 2.01 1.31 - 2.02

6

1.25

14

1.28

10.3

0.69 - 3.17 1.1 0 - 1.62

11

1.23

7.4

1.1 0 - 1.38

panel 1

z-score

panel 2

z-score

panel 3

z-score

~. ,ECAT ~

Survey: 2013-1



FOUNDATION

Labeode:


I

9907152

I Confirmation


Sampie No Sampie Details


Stability

31-December-2015

Homogeneity

0.80 %

Assay

Positive

APTT dAPTT dPT dRWT KCT Other PNP PT SCT

18 6 5 228 1 1 3 1 2

Borderline

n

APTT

80 13 11 27 7 11 5 9 336 15 41 40 17 14 114 61 9 5 35 33

I.L. MixCon Siemens Actin FS Stago/Roche

Stadot LA

dAPTT StagolRoche

Staclot LA

dPT

dRVVT American

Diagnostics

I.L. HemoslL dRWT

DWconfirm confirm

I.L. LAC confirm Life Diagnostics

LA confirm

Precision Biologie LA sure Siemens lA2 confirma!ion Stago/Roche

DRWT

Technoclone

LA Confirm

PNP SCT I.L. SCT confirm

Confirm

assigned value

1.43 1.25 1.28 1.58 1.20 1.40 1.25 1.55 1.72 2.68 1.76 1.77 1.75 1.62 1.69 1.65 1.81 1.50 2.01 2.01

2 0 0 3 0 0 0 0 0

CV (%)

range

18.6 5.4 3.6 11.0

1.00 - 2.20 1.01 -1.38 1.03-1.34 1.28 - 1.89 1.00-1.27 1.13-1.93 1.21-1.47 0.57 - 2.17 1.00 - 3.52 1.29 - 3.52 1.31 - 2.56 1.29 - 2.19 1.44 - 1.99 1.40-1.87 1.00 - 2.05 1.15 - 2.01 1.29 - 1.91 1.28 - 1.80 0.60 - 2.66 0.60 - 2.50

20.1

10.3 26.4 8.0 7.8 7.3 8.8 8.5 12.1

17.7 16.0

Your result

No Classification

82 9 3 78 1 1 10 1 35

16 1 1 64 0 0 1 0 1

Ratio

I.L. Hemosil SynthAFax

Negative

Confirm 1

Confirm 2

LA Positive

LA Positive

panel 1

z-score

panel 2

1.70

-0.14

1.82

1.70

0.05 1.82

z-score

0.55

Confirm 3

panel 3

z-score

ECAT

Survey: 2013-1

Extemal quality Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis


FOUNDATION

Labeode:

9907152

I Ratio Screening/Confirmation

I Lupus Anticoagulant No. of Responders 429



Stability

31-December-2015

Homogeneity

0.80 %

Ratio Screening/Confirmation

n

assigned value

CV (%)

range

1.06 1.12 1.33 0.75

13.0

0.65 - 1.57 0.83-1.74 0.29 - 1.90 0.48 - 1.35

APTT dAPTT dRWT

I I

73 8 356

SCT

I

36

Assays 10

"E

6

:l

o

U

20

.Other

seT

12.6 13.1

panel 1

z-score

panel 2

z-score

1.56

1.34

1.36

0.16

panel 3

z-score

Survey: 2013-1

Extemal quality Contral for Assays and Tests With a foeus on Thrambosis and Haemostasis

Page 11 of 18 04-June-2013

FOUNDATION

Labeode:

I AntiCardiolipin


9907152

Antibodies IgG



13.07 Normal pooled plasma enriched with approx. 200 ng/mL Rivaroxaban Units: GPL, IJg/mL, Other Prior Use: None

Stability

31-December-2015

Homogeneity

0.80 %

Negative

Classification

I Total

Borderline

170

low Positive

0 n

IgG

assigned

1

0

CV (%)

range

55.6

0.0 - 13.1

value

-

Total Group 115

GPL Aeskulisa

Diagnotic GmbH

Corgenix REAADS INOVA Diagnostics

Inc.

2.6

5

1.0

6

3.8

14

4.4

0.6 - 2.2 3.0 - 6.4 69.6

0.0 - 10.0

Orgentec

18

1.2

71.5

0.0 - 13.1

Orgentec (Alegria)

16

2.5

20.1

2.0 - 3.5

Phadia

28

2.8

16.4

0.0 - 3.5

IJglmL

1

0.2

Other

19

2.5

7

2.8

I.L. Acustar

GPL 45 40 35

-

30

NtOOVI'-..-I,()OONtOCO

060"....:,....:NNNMMM~...j-.i A

.Other

seT

Comments Approximately 46% of the performed confirmation tests were c1assified as positive, 15% as borderline and 38% as negative. It is obvious that the majority of the performed APTT test (69%) was c1assified as negative. For the dRVVT test this is only 21 %.

Survey: 2013-1

Extema/ qua/ity Contra/ for Assays and Tests With a foeus on Thrambosis and Haemostasis


FOUNDATION

Labeode:

APTT

9907152

DRWT

60

50

.I.

40

c :l

0 U

30

v

.Other APTT

o

U

•

10

ooo"--:"--:"--:"--:"--:"--:"--:NNNNN

:l

I

20

°c.oMr--O~CONiJ)mMr--"""VCOiJ) r--oom'l""""NMlOWf'..mONM'l:tlO

I

•..c:

10

°COOl.()OLOm..::rmvQ)MCOMCOCD

-

o

~~~""""":~~~