ecat foundation - lkf-kiel.de · ratio n assigned cv (%) panel 2 range panel 1 z-score value...

ECAT FOUNDATION External quality Control for Assays and Tests

With a focus on Thrombosis and Haemostasis

REPORT

SURVEY 2019-M3 Lupus Anticoagulant

Labcode 9907152

Copyright © 2019 ECAT Foundation

Lupus Anticoagulant

Screening

Survey: 2019-M3

Page 3 of 14 28-October-2019 Labcode: 9907152 Version: 1.0.0

E C A "1r FOUNDATION

TExternal quality Control for Assays and Tests VVith a focus on Thrombosis and Haemostasis

Sample No Sample Details Prior Use Unit

Expiry Date

Homogeneity Number of Participants

Number of Responders

Comments

19.120 Plasma moderate positive for Lupus Anticoagulant (LA Ratio approx. 1.7)

Prior Use: None

Units: Ratio

19-May-2021 1.6%

Homogeneity Parameter LA ratio 604

541

Response Rate

90%

Assay Normal Borderline Prolonged No Classification

Your result

Screening 1 Screening 2 Screening 3 APTT 18 13 339 3 dAPTT 0 0 16 0 dPT 1 1 5 0 dRVVT 9 2 514 12 Prolonged KCT 0 0 3 0 Other 0 0 6 0 PNP 0 0 2 0 PT 0 0 5 0 SCT 5 0 104 5

Ratio n assigned CV (%) range panel 1 z-score value

panel 2 z-score panel 3 z-score

APTT 318 1.80 24.3 ! 0.95 - 3.47 , IL APTT SP 49 2.16 14.6 1.59 - 3.08 IL HemosIL SynthAsil 29 1.89 8.0 1.02 - 2.12 IL MixCon 13 1.62 19.8 1.16 - 2.22 Siemens Actin FS 9 1.22 0.95 - 1.50 Siemens Actin FSL 57 1.59 10.2 1.19 - 2.03 Siemens Pathromtin SL 30 1.24 5.0 1.01 - 1.57 Stago PTT Automate/STA APTT 22 1.57 5.8 1.30 - 1.76 Stago PTT LA 71 2.15 12.8 1.47 - 3.47 Stagoe Staclot LA 6 1.60 1.22 - 1.76 Tcoag TriniClot APTT-HS 7 1.97 1.58 - 2.26

dAPTT 12 2.33 19.7 1.60 - 3.59 Stago PTT LA 9 2.42 1.95 - 2.81

dPT 6 1.91 1.20 - 2.35 dRVVT 478 1.72 11.0 0.86 - 3.30 2.02 1.59 I.L. HemosIL dRVVT screen 156 1.83 9.7 1.03 - 3.30 I.L. LAC screen 10 1.87 16.7 1.42 - 2.31 Precision Biologic LA check 14 1.63 8.8 0.86 - 2.10 Siemens LA1 screen 183 1.69 8.7 0.99 - 2.61 Stago DRVVT screen 89 1.62 9.8 1.28 - 2.17 Technoclone LA Screen 7_ 1.61 1.58 - 2.02 2.02

Other 5 1.78 1.12 - 2.27 SCT 105 3.15 11.9 1.75 - 4.62 Haematex SACT Reagent 7 3.06 2.44 - 4.50 IL SCT screen 98 3.16 11.5 1.75 - 4.62

1, EcAT External quality Control for Assays and Tests

VVith a focus on Thrombosis and Haemostasis

% FOUNDATION

Survey: 2019-M3


Lupus Anticoagulant

Mixing

Sample No Sample Details

Prior Use Unit

Expiry Date Hornogeneity

Number of Participants


Comments


Prior Use: None

Units: Ratio

19-May-2021 1.6%

Homogeneity Parameter LA ratio 604

372

Response Rate

62%

Assay Normal Borderline Prolonged No Classification

Your result

Mixing 1 Mixing 2 Mixing 3 APTT 24 9 236 2 dAPTT 0 0 17 0 dPT 1 0 2 0 dRVVT 33 13 220 1 KOT 0 0 2 0 Other 0 0 3 0 PT 0 0 0 0 SCT 1 2 49 1

Ratio n assigned CV (%) range panel 1 z-score value


,APTT

244 1.48 16.7 0.88 - 2.89 IL APTT SP 38 1.67 7.5 1.50 - 2.27 IL HemosIL SynthAsil 21 1.50 11.0 0.99 - 1.86 IL MixCon 11 1.44 9.2 0.88 - 1.57 Siemens Actin FSL 36 1.32 9.0 0.97 - 2.61 Siemens Pathromtin SL 17 1.13 7.8 1.00 - 1.30 ' Stago PTT Automate/STA APTT 24 1.32 5.0 1.22 - 1.53 Stago PTT LA 68 1.61 9.6 1.18 - 2.89 Tcoag TriniClot APTT-HS 6 1.64 1.28 - 1.76

dA PTT 13 1.69 11.0 1.31 -2.42 Stago PTT LA 9 1.78 1.31 -2.42

dRVVT 248 1.35 10.9 0.81 -2.29 I.L. HemosIL dRVVT screen 48 1.49 10.1 1.10 - 2.29 Precision Biologic LA check 6 1.40 1.30 - 1.44 Siemens LA1 screen 117 1.31 8.4 0.92 - 2.16 Siemens LA2 confirmation 7 0.96 0.85 - 1.39 Stago DRVVT screen 49 1.35 9.3 1.15 - 1.76

SCT 52 2.39 13.0 0.63 - 4.50 Haematex SACT Reagent 5 2.63 0.63 - 4.50 IL SCT screen 46 2.40 11.5 1.51 -2.83

EC A T External quality Control for Assays and Tests


zy FOUNDATION

Survey: 2019-M3


Lupus Anticoagulant

Confirmation


Expiry Date Homogeneity Number of Participants


Comments


Prior Use: None

Units: Ratio

19-May-2021

1.6%

Honiogeneity Parameter LA ratio

604

534

Response Rate

88%

Assay Positive Borderline Negative No Classification

Your result

Confirm 1 Confirm 2 Confirm 3 APTT 151 4 4 2 dAPTT 19 0 0 0 dPT 6 0 2 0 dRVVT 526 8 12 6 LA Positive KOT 1 0 0 0 Other 10 0 0 0 PNP 12 1 1 0 PT 1 0 1 0 SCT 104 1 1 0

Ratio assigned CV (y 0) range panel 1 z-score value


APTT

1031 1.21 11.4 0.85 - 3.11 IL Hemosil SynthAFax 18 1.15 5.5 1.07 - 1.44 1 IL MixCon 14 1.34 24.8 1.08 - 1.93 _ Siemens Actin FS 41 1.16 6.3 0.97 - 1.51 Stago Staclot LA 13 1.26 22.3 0.85 - 2.81 . Technoclone Lupus Anticoagulant Test 5 1.51 - 1.33 - 2.48

dAPTT 5 1.26 1.05 - 1.80 dPT 6 1.14 0.99 - 2.41 dRVVT 465 1.02 7.2 0.78 - 2.91 1.22 2.68 IL HemosIL CRVVT confirm 146 1.02 6.6 0.87 - 2.91 IL HemosIL LAC confirm 21 1.01 7.2 0.91 - 2.26 Precision Biologic LA sure 9 1.03 0.81 - 1.91 Siemens LA2 confirmation 176 1.02 7.4 0.78 - 1.73 Stago DRVVT Confirm 82 1.02 6.4 0.83 - 1.81 Technoclone LA Confirm 8 1.02 0.93 - 1.22 1.22

Other 5 1.12 0.86 - 1.24 Other 5 1.12 0.86 - 1.24

SCT 99 1.29 10.6 0.94 - 2.74 IL HemosIL SCT confirm 97 1.29 10.6 0.94 - 2.74

EC T External quality Control for Assays and Tests VVith a focus on Thrombosis and Haemostasis

JV • FOUNDATION

Survey: 2019-M3


Lupus Anticoagulant

Ratio Screening/Confirmation

Sample No 19.120 Sample Details Plasma moderate positive for Lupus Anticoagulant (LA Ratio approx. 1.7) Prior Use Prior Use: None Unit Units: Ratio

Expiry Date 19-May-2021 Homogeneity 1.6 %

Number of Participants 604

Number of Responders 462

Comments

Homogeneity Parameter

Response Rate

LA ratio

76.49%

Ratio Screening/Confirmation assigned CV range value

panel 1 z-score panel 2 z-score panel 3 z-score

APTT 111 1.53 17.1 1.00 - 22.40 dAPTT 7 1.64 1.09 - 2.85 dRVVT 530 1.74 10.6 0.93 - 2.90 1.54 _ -1.08 Other 5 1.62 0.68 - 1.66 . SCT 101 2.45 13.0 1.64 - 3.40

Assays

240

210

180

150

0 o • 120

90

60-

30-

r- CO 0 0 0

• Other SCT

• dRVVT BAPTT

/7, 17..re

Lupus Anticoagulant AntiCardiolipin Antibodies IgG

Homogeneity Parameter LA ratio

Response Rate 38%

19.120 Plasma moderate positive for Lupus Anticoagulant (LA Ratio approx. 1.7) Prior Use: None Units: GPL, U/mL, CU/mL, Other 19-May-2021 1.6% 604 227

IgG assigned CV (%) value

range Your result z-score

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

FOUNDATION

Survey: 2019-M3


Sample No Sample Details Prior Use Unit Expiry Date Homogeneity Number of Participants Number of Responders Comments

Negative Borderline Low Positive Medium Positive High Positive No Conclusion

97 11 25 36 57 1

GPL 138 12.8 56.8 0.0 - 285.0 Aeskulisa Diagnotic GmbH 7 19.0 11.0 - 48.1 INOVA Quanta Ute 14 8.2 36.5 0.0 - 14.2 Orgentec (Alegria) 12 16.9 18.2 13.1 -25.5 Orgentec (Elisa) 20 21.5 36.4 9.4 - 69.2 Reaads 5 31.0 29.5 - 37.0 Thermo Scientific EliA 66 8.7 11.1 2.0 - 116.0

U/mL 18 13.8 92.6 5.1 - 247.0 Euroimmun 12 7.2 27.8 5.1 - 10.0 CU/mL 57 150.3 10.9 21.2 - 191.0 I.L. Acustar / INOVA Quanta Flash 56 150.3 11.1 21.2 - 191.0

Other 1 1.2 1.2 - 1.2

GPL 90

80-

70

60-

c.)

4-•

50-

40-

30-

20-

au MIN8 7"). co lel "rle 6J eh 11111 V CD x- In LO 03 . . . . . . . . . . . co cr) N N C33 0'3

x- NNNCInele

MOther BOrgentec (Alegria) BOrgentec (Elisa) Thermo Scientific EliA INOVA Quanta Ute

Comments Please be aware of the proper use of units. We have frequently observed the use of different units by participants using the same method while their results are comparable. For now we have harmonised the units. However it is the participant's responsibility to use the correct units!

10-

Classification

Total

E C A Ex.temal quality Control for Assays and Tests VVith a focus on Thrombosis and Haemostasis

FOUN DATION Version: 1.0.0

Survey: 2019-M3

Page 13 of 14 28-October-2019 Labcode: 9907152

Lupus Anticoagulant

ß2-Glycoprotein 1 Antibodies 1gG

Sample No Sample Details Prior Use Unit Expiry Date Homogeneity Number of Participants Number of Responders Comments

19.120 Plasma moderate positive for Lupus Anticoagulant (LA Ratio approx. 1.7) Prior Use: None Units: U, U/mL, CU/mL, Other 19-May-2021 1.6% Homogeneity Parameter LA ratio 604 201 Response Rate 33%

Classification Negative Borderline Low Positive Medium Positive High Positive No Conclusion

Total 26 8 58 52 56 1

IgG • assigned CV (%) range Your result z-score value

U 125 16.7 26.6 8.0 - 240.0 Aeskulisa Diagnotic GmbH 9 17.0 8.3 - 28.2 INOVA Quanta Lite 18 18.1 27.1 8.0 - 26.8 Orgentec (Alegria) 11 11.9 28.7 8.3 - 27.6 Orgentec (Elisa) 19 15.4 29.5 8.1 -39.0 Thermo Scientific EliA 60 16.3 12.6 9.0 - 118.0

U/mL 15 13.4 30.4 2.5- 124.5 Euroimmun 8 12.8 9.1 - 124.5

CU/mL 53 260.3 14.8 175.2 - 344.2 I.L. Acustar / INOVA Quanta Flash 53 260.3 14.8 175.2 - 344.2

Other 1 1.5 1.5 - 1.5

70

60-

50-

40-0

30-

20

011 P. «.11111m

10

(.0 • CO N CO 0 0 CO 03 • CD d c‘i CD ai N CN N C.3 (Y)

• Other • Orgentec (Alegria) BOrgentec (Elisa) Thermo Scientific EliA INOVA Quants Ute


50

40-

30-

20-

0 III IM 119 ä oo co csi do 17 v in C•I CO 0) C,) e ä ä ä (Ni ei ri •e'

1"Ch-

›it,ECAT Ewix tt ernal cq uu s n Th aloityCo rnotrmo bl foosris d fim A assnays aaend oTsetsatss h a fo is

FOUNDATION

Survey: 2019-M3 Page 14 of 14 28-October-2019 Labcode: 9907152 Version: 1.0.0

ß2-Glycoprotein 1 Antibodies 1gM Lupus Anticoagulant




Comments


Prior Use: None

Units: U, U/mL, CU/mL, Other

19-May-2021 1.6%


604

172

Response Rate

28%

Classification Negative Borderline Low Positive Medium Positive High Positive No Conclusion

Total 171 0 0 1 0 0

IgM assigned CV (%) value

Your result z-score

U 71 1.2 70.9 0.0 - 16.0 Aeskulisa Diagnotic GmbH 9 1.0 0.7 - 4.0 INOVA Quanta Lite 8 2.1 0.0 - 9.4 Orgentec (Alegria) 10 0.8 23.6 0.6 - 7.0 Orgentec (Elisa) 14 0.9 59.7 0.2 - 3.0 Therme Scientific EliA 21 1.4 80.4 0.0 - 16.0

UlmL 9 2.0 0.0 - 7.0 CU/mL 23 1.0 19.8 0.6 - 1.3 I.L. Acustar / INOVA Quanta Flash 23 1.0 19.8 0.6 - 1.3

Other 1 0.1 0.1 -0.1

• Other nOrgentec (Alegria) • Orgentec (Elisa) Thermo Scientific EliA


0 cS

60

50-

20-

10-

10111 .01/11ffli

N cJ CID a) 0 0 .-

N e, er in co r- co c•i ui ei . . . . .

• Orgentec (Elisa)

14•1 r--

• Other ZI 0 rg entec (Alegria)

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

IN FOUNDATION

Survey: 2019-M3


Lupus Anticoagulant

AntiCardiolipin Antibodies IgM




Comments


Prior Use: None

Units: MPL, U/mL, CU/mL, Other

19-May-2021 1.6%


604

205

Response Rate

34%

Negative Borderline Low Positive Medium Positive High Positive No Conclusion

202 1 2 0 0 0

Classification

Total

IgM assigned CV (%) value

range Your result z-score

U/mL _ 6 2.1 0.0 - 3.0 _ . -CU/mL 49 1.3 14.4 0.9 - 2.0 I.L. Acustar / INOVA Quanta Flash 49 1.3 14.4 0.9 - 2.0

Other 1 0.1 0.1 -0.1 MPL 127 2.1 62.6 0.0 - 17.0 Aeskulisa Diagnotic GmbH 7 1.0 1.0 - 3.7

-Bio-rad EIA 8 0.7 0.5 - 3.3 INOVA Quanta Lite 14 8.0 23.4 0.0 - 17.0 Orgentec (Alegria) 11 0.7 16.5 0.6 - 1.0 Orgentec (Elisa) 15 1.2 ' 46.6 - 0.7 - 13.7 Reaads 5 3.7 2.0 - 4.2 Thermo Scientific EliA 58 2.1 23.2 1.0 - 10.0

MPL

Thermo Scientific EILA• INOVA Quanta Lite


›-* ECAT External quality Control for Assays and Tests

VVith a focus on Thrombosis and Haemostasis

Version: 1.0.0

Survey: 2019-M3 of 14 28-October-2019 Labcode: 9907152 lel FOUNDATION

Lupus Anticoagulant

Final Conclusion

Negative Borderline Positive No Conclusion Your Result

5 8 448 1 Positive

Final Conclusion

Total

Comments

Ratio Screen/Confirm Several participants reported a value for the ratio screen/confirm which actually was not likely to be a ratio screen over comfirm. Therefore these results were excluded from the statistical analysis.

Final conclusion The sample used in this survey was plasma from a patient diagnosed with Lupus Anticoagulant (LA Ratio = approx. 1.70). No other types of inhibitors were present.

In total 462 participants gave a final conclusion. Of the participants who gave a final conclusion, approximately 97% classified the sample as positive. Two percent classified the sample as borderline. 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.

e EC AT External quality Control for Assays and Tests


--Lr FOUNDATION


Assavs 370 350

300

250-

3 200

150-

100-

50-

Mg 911 19. L1, <41 6 rz- co e co N er) 70- N e N. Lt" N-C»CDNCO 6ciädc; . . . .

N N N

wOther adRVVT •APTT

SCT

Comments Several participants selected the wromg unit, e.g. ratio while the result was likely to be in seconds or vice versa. Several participants reported their result for the ECAT plasma in seconds while the result for their reference plasma was reported as a ratio. One participant reported a negative result for their reference plasma. In all these cases the ratio between the ECAT plasma and the laboratories own reference plasma could not be correctly calculated. Therefore all these results were excluded from the statistical analysis.

The vast majority of the performed confirmation tests (approx. 95%) were classified as borderline or positive.

0

APTT DRVVT Assavs 90

80-

70-

60-

7▪ • 50-

40-

30-

20-

10-

▪ v- co co co cs) 'et CO CO CO CO 03 0)

A

210-

180-

150-

0120-

90-

60-

30-

0

60 240

50-

40

1 (.) 30- 0

20

10

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

,w FOUNDATION

Version: 1.0.0

Survey: 2019-M3 Page 6 of 14 28-October-2019 Labcode: 9907152

BOther •dRVVT

SCT IldAPTT • APTT B Other alSiernens Pathromtin E MSjemens Actin FSL MOther RSjemens IIStago DRVVT screen

IL APTT SP IllStago PTT LA 77, PTT Auto mataiSTA AF I.L. dRVVT screen BIL Hemosl L SynthAsil

Comments Several participants selected the wromg unit, e.g. ratio while the result was likely to be in seconds or vice versa. One participant reported the result for the ECAT plasma in seconds while the result for the reference plasma was reported as a ratio. One participant reported a negative result for their reference plasma. In all these cases the ratio between the ECAT plasma and the laboratories own reference plasma could not be correctly calculated. Therefore all these results were excluded from the statistical analysis.

The majority of performed mixing tests (approx. 90%) were classified as (borderline) prolonged.

MAPTT • Other •dRVVT SCT •dAPTT

• Ot h e r •Siemens Pathromtin 0 USiemensActin FSL BOther IL APTT SP •Stago PTT LA PI PTT Automate/STA AF Prec Bio I

• IL HemosIL SynthAsil

• Siemens B Stago DRVVT screen I.L. dRVVT screen

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

S FOUNDATION


Assays 80

370 350-

70-

300- 60-

250- 4-, 50-

200- 0 0 40-

150- 30-

100- 20-

50- 10-

0 lir iji le "Z" cb v

cb dr) c:i to co ,— e 77) 6) 6.1 cb e co ,— e co ,— e co ,-- e •,— cv

0

czi czi ci ., c‘t c‘i cV ei ei ei -d' ,i A

APTT DRVVT

Comments Several participants selected the wromg unit, e.g. ratio while the result was likely to be in seconds or vice versa. A few other participants reported their result for the ECAT plasma in seconds while the result for their reference plasma was reported as a ratio. One participant reported a negative result for their reference plasma. In all these cases the ratio between the ECAT plasma and the laboratories own reference plasma could not be correctly calculated. Therefore all these results were excluded from the statistical analysis.

The majority of performed screening tests (approx. 97%) were classified as (borderline) prolonged.

170 160-

120-

4-+

0 80-

40-

0 e

cNi KI (Ni (Ni KI (Ni c\i A

Irh_ Lb lel lio II- I L b 119 11:- c I IM IIII I CO r•-• o) 4— ei .0 N— CO 0 rsl 'ci- c0 co 0 OO Qczi * * * • • (Ni ( , i c,i c.i cv. ci ei V A V

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

% FOUNDATION Version: 1.0.0

Survey: 2019-M3

Page 2 of 14 28-October-2019 Labcode: 9907152

Date of lssue : 28-October-2019

Survey : 2019-M3

Report Lupus Anticoagulant

Note: In the Survey Manual 2019 detailed information is given regarding the ECAT external quality assessment programme, including the statistical evaluation and explanation of the report. This Survey Manual 2019 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 Decemeber 3rd, 2019. Complaints received after this date will not be taken into consideration.

Exclusion of results Results < [value] or > [value] are excluded from the statistical analysis. When other results are excluded from the statistical analysis, these results are placed between brackets.

Use of units We observed several issue of improper use of units during this survey.

Lupus Anticoagulant See comments in the respective sections.

Antiphospholipid Antibodies Please be aware of the proper use of units. We have frequently observed the use of different units by participants using the same method while their results are comparable. For now we have harmonised the units. However it is the responsibility of the participant to use the correct units!

This report is authorized by:

P. Meijer 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 107 2250 AC Voorschoten, The Netherlands phone +31(0) 71 3030 910; fax + 31(0) 71 3030 919 E-mail: [email protected] Website: www.ecat.n1 VAT number: NL802836872B01

Registration number with the Chamber of Commerce (KvK) Gouda : 41174102 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 integral part of the total report.

ecat foundation - lkf-kiel.de · ratio n assigned cv (%) panel 2 range panel 1 z-score value...

Documents