Survey Report 2010-1 LA.pdf - NASCOLA

ECAT FOUNDATION EXERCISE 2010-1 

INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 1 of 12 

PROGRAMME IN HAEMOSTASIS AND THROMBOSIS Print date: 08 June 2010 

Copyright © 2010 ECAT Foundation 

Labcode: 900 

LUPUS ANTICOAGULANT 

LABORATORY CODE NUMBER: 900 

Test plasma : 10.06 

Type of plasma : Low Lupus Inhibitor Plasma (Technoclone, lot no. 2U92A00). 

Former used in exercise : 2009-4 

Number of participants : 429 

Number of responders : 362 

Participation rate : 84% 

General remarks 

1. To make the calculation of ratios possible we entered the maximum measured value into the database 

when results were reported as >[value]. 

2. Seven participants did not gave a final conclusion (!). 

Negative classification 

This (weakly) positive lupus sample was negatively classified by only 7 participants (~2%). 

Screening tests 

About 7% of the screening tests was classified as normal. For the APTT assay group this percentage was 

about 13% and for the DRVVT assay group about 2%. 

The only APTT reagent with a relative high percentage of normal classification was Actin FSL (Siemens): 

~33%. 

Mixing tests 

About 25% (n=113) of all mixing tests (n=456) was classified as normal. 

For the APTT assay group this was ~24% and for the DRVTT assay group ~27%. 

From the most frequently used APTT reagents (n ≥ 10) the rate of normal classification is: 

Pathromtin SL (Siemens, n=14) [64%] and Actin FSL (Siemens, n=31) [59%]. 

From the most frequently used DRVVT reagents (n ≥ 10) the rate of normal classification is: 

LA screen (Siemens, n=83) [27%], LA screen (Life Diagnostics, n=26) [12%], LAC screen (I.L., n=18) 

[35%], LA Check (Precision Biologic, n=14) [21%], DRVVT screen (Stago, n=16) [19%]. 

Confirmation test 

In the confirmation test the number of negative classification was 69 (~ 13%). 

The only reagents with a percentage of negative classification > 10% were LA confirm (Siemens) [13%] and 

LAC confirm (I.L) [15%], 

In general there is no clear pattern in test combinations which is responsible for the negative 

classification of this sample.





Labcode: 900 

Overview of methods used for lupus anticoagulant testing 

Screen Mix Confirm 

Code Description No. No. No. 

002 American Diagnostica DVVconfirm 3 2 22 

001 American Diagnostica DVVtest 21 9 2 

011 American Diagnostica ActiClot dPT 10 3 9 

003 AMAX Accuclot dRVVT screen 1 1 

004 AMAX Accuclot dRVVT confirm 1 

014 BDH Kaolin light 

018 Biodata Corporation Platelet extract reagent 

012 Biopep: LA check 

013 Biopep: LA sure 

096 Dialab APTT-SMA 2 

023 Diagen BeA 

037 Diagen Dia PTT 

024 Diagen KPS 

112 Diagen Micronised Silica APTT 1 

070 Diagen RVV 

119 Diagnostic Lupotek KCT reagent 

087 Enzyme Research R2 Diagnostics 2 3 1 

016 Haemachrom KCT 1 1 

123 Haematex SACT reagent 1 

076 Helena BioSciences DRVVT confirm 1 

075 Helena Biosciences DRVVT screen 

078 Helena/Ortho Synth. A Fax 

089 Hemoliance SynthaFax 

079 Hemoliance Synthasil APTT 1 1 

091 Hemoliance Thrombosil 

069 Homemade Kaolin 7 7 

017 Homemade Platelet Lysate 4 

122 Hyphen Biomed Cephen 1LS 1 1 

030 I.L. APTT Lyophilized Silica 5 3 7 

029 I.L. APTT SP 36 24 4 

106 I.L. HemosIL Recombiplastin 3 2 

088 I.L. HemosIL SynthASil 15 7 1 

098 I.L. HemosIL SynthAFax 2 9 

032 I.L. LAC confirm 2 73 

031 I.L. LAC screen 69 18 4 

094 I.L. MixCon 7 4 6 

090 I.L. PT-Fibrinogen Recombinant 

104 I.L. SCT screen 16 4 

105 I.L. SCT confirm 13 

034 Immuno Dapttin 2 

033 Immuno Lupus Anticoagulant Test 

120 Kaogen KaoTime 

121 Kaolup Confirm 1 

035 Kordia LAC kit (Unicorn) 

036 Kordia RVV-X C1(rabbit cefaline) 

025 Life Diagnostic Gradilin 

026 Life Diagnostic Kaoclot 10 10 1 

028 Life Diagnostic LA confirm 3 3 39 

027 Life Diagnostic LA screen 42 26 2 

038 Manchester Diagnostics DRVVT reagents 

040 Nycomed Cephotest 

041 Nycomed Nycoplastin 1 

050 Ortho Recombiplastin 

051 Ortho Synthasil 1 1 

080 Precision Biologic LA check 25 14 3 

081 Precision Biologic LA sure 1 1 23 

095 Precision Biologic Platelet Lysate 7





Labcode: 900 

Screen Mix Confirm 

Code Description No. No. No. 

077 R 2 Diagnostics DRVVT confirm 

101 R 2 Diagnostics DRVVT screen 1 

117 R 2 Diagnostics LupoTek KCT 1 2 1 

102 Renam APTT 

074 Renam dRVVT confirm 

073 Renam dRVVT screen 

071 Renam Erilyrd-Kaolin 

072 Renam Renamplastin 

019 Siemens Actin 1 1 

020 Siemens Actin FS 4 2 19 

021 Siemens Actin FSL 51 34 3 

022 Siemens Innovin 16 16 5 

005 Siemens LA1 screen 148 86 3 

006 Siemens LA2 confirmation 1 5 146 

007 Siemens Pathromtin SL 25 17 

086 Siemens Thromboplastin C+ 

085 Siemens Thromborel R 

008 Siemens Thromborel S 1 2 

700 Siemens ProC Global 1 

066 Stago / Roche APTT Kaolin 

093 Stago / Roche Cephascreen 1 

066 Stago / Roche CKPrest / Kaolin 7 1 

108 Stago / Roche DRVVT confirm 1 32 

107 Stago / Roche DRVVT screen 36 16 3 

109 Stago / Roche Neoplastin CI 1 

110 Stago / Roche Neoplastin R 

067 Stago / Roche Neoplastin Cl+ 2 2 2 

062 Stago / Roche PTT Automate / STA APTT 29 21 1 

057 Stago / Roche PTT LA 79 71 6 

054 Stago / Roche SPA50 

058 Stago / Roche Staclot LA 11 4 52 

068 Technoclone Lupus Anticoagulant Test 3 5 4 

124 Technoclone LA Screen 1 

083 Trinity Biotech Accuclot DRVVT confirm 1 

082 Trinity Biotech Accuclot DRVVT screen 2 3 2 

042 Trinity Biotech Amax Alexin 

103 Trinity Biotech Amax Alexin HS 

052 Trinity Biotech APTT 1 

046 Trinity Biotech Automated APTT 6 5 1 

015 Trinity Biotech Bioclot LA 

010 Trinity Biotech Hemolab Silimat 

084 Trinity Biotech Kaolin 1 1 

043 Trinity Biotech Platelin L 6 4 

045 Trinity Biotech Platelin LS 9 7 2 

053 Trinity Biotech RVV 

044 Trinity Biotech Simplastin 1 1 

111 Trinity Biotech Simplastin HTF 

118 Trinity Biotech TriniClot APTT-HS 7 1 1 

115 Trinity Biotech TriniClot APTT-S 1 

048 Trinity Biotech Viperquik LA-check 

047 Trinity Biotech Viperquik LA-Test 

065 Unicorn DRVVT 2 1 

097 Unichrom LA-DRVVT 

116 Vital Diagnostics Vitaclot 1 1 

099 Unknown 9 7 11





Labcode: 900 

Overview ratio ECAT plasma / normal plasma 

RATIO SCREENING n mean CV Range 

APTT 249 1.51 20.5% 0.63 – 2.66 

APTT SP (IL) 29 1.64 9.1% 1.40 – 2.08 

HemosIL SynthASil (IL) 14 1.36 13.2% 0.95 – 1.58 

Pathromtin SL (Siemens) 22 1.17 6.8% 0.95 – 1.37 

Actin FSL (Siemens) 39 1.23 8.1% 0.96 – 1.43 

PTT Automate / STA APTT 

(Stago) 

24 1.52 7.9% 1.30 – 1.78 

PTT LA (Stago) 73 1.79 15.6% 0.63 – 2.66 

DRVVT 293 1.47 10.9% 0.98 – 2.26 

DVVtest (AD) 17 1.48 11.5% 1.16 – 1.72 

LAC screen (I.L.) 64 1.53 9.2% 1.24 – 2.26 

LA screen (Life Diagnostics) 38 1.51 11.9% 1.03 – 1.87 

LA check (Precision Biologic) 18 1.35 7.3% 1.15 – 1.60 

LA1 screen (Siemens) 109 1.43 9.1% 1.10 – 1.76 

DRVVT Screen (Stago) 33 1.52 12.5% 1.11 – 1.93 

KCT 23 1.86 44.1% 0.80 – 4.36 

dAPTT 20 1.57 25.5% 0.98 – 2.47 

dPT 31 1.46 17.1% 0.91 – 1.84 

Innovin (Siemens) 15 1.64 10.4% 1.25 – 1.84 

Acticlot dPT (AD) 10 1.31 10.7% 1.13 – 1.58 

SCT 10 2.28 20.6% 1.34 – 2.77 

Other 2 1.40 1.15 – 1.64 

Remarks: 

The high CV of the KCT-group in comparison to the other assay groups is remarkable. 

This is probably caused by a variation in test conditions used by the different participants. 

RATIO MIXING n mean CV range 

APTT 183 1.34 17.2% 0.96 – 2.36 

APTT SP (IL) 21 1.44 12.5% 1.00 – 1.72 

Pathromtin SL (Siemens) 17 1.08 5.4% 0.96 – 1.21 

Actin FSL (Siemens) 28 1.16 5.0% 1.05 – 1.29 

PTT LA (Stago) 64 1.52 11.8% 1.21 – 2.36 

DRVVT 168 1.19 10.1% 0.57 – 1.75 

LAC screen (I.L.) 17 1.25 12.0% 1.09 – 1.75 

LA screen (Life Diagnostics) 24 1.26 8.7% 0.97 – 1.43 

LA1 screen (Siemens) 76 1.17 7.2% 1.01 – 1.53 

DRVVT Screen (Stago) 16 1.27 16.5% 1.14 – 1.47 

KCT 24 1.36 21.3% 0.82 – 1.96 

dAPTT 17 1.47 17.0% 1.04 – 1.84 

dPT 22 1.27 15.7% 1.08 – 1.96 

Innovin (Siemens) 16 1.30 17.7% 1.08 – 1.96 

SCT 4 1.61 1.41 – 1.79 

Other 2 1.09 1.04 – 1.13





Labcode: 900 

RATIO CONFIRMATION n mean CV range 

APTT 58 1.13 16.8% 0.75 – 1.90 

Actin FS (Siemens) 17 1.02 8.5% 0.76 – 1.14 

PT 8 1.21 1.04 – 1.81 

DRVVT 293 1.09 12.8% 0.79 – 2.17 

DVV Confirm (AD) 16 1.11 14.4% 0.91 – 1.43 

LAC confirm (I.L.) 66 1.08 7.3% 0.88 – 1.37 

LA confirm (Life Diagnostics) 35 1.08 11.1% 0.89 – 1.54 

LA Sure (Precision Biologic) 12 1.03 12.6% 0.82 – 1.30 

LA2 confirmation (Siemens) 109 1.07 11.2% 0.88 – 1.59 

DRVVT Confirm (Stago) 30 1.04 9.1% 0.79 – 1.24 

KCT 1 1.07 

PNP 15 1.17 27.4% 0.80 – 1.90 

dAPTT 9 1.23 0.87 – 1.51 

dPT 5 1.10 0.98 – 1.19 

SCT 11 1.31 21.4% 1.06 – 2.01 

Comparison classification survey 2009-4 and 2010-1 

In this survey the same sample was distributed as in survey 2009-4. In totally 259 participants had participated 

in both surveys. Of them 59% gave the same final conclusion in both surveys. 

The table below shows the comparison of the classification of both surveys in detail. 

2009-4 

2010-1 

Normal Borderline Weakly Positive 

Positive 

Strongly 

Positive 

No 

classification 

Normal 5 2 1 5 0 0 

Borderline 1 4 2 0 0 0 

Weakly Positive 1 7 15 19 1 0 

Positive 3 6 17 99 17 0 

Strongly Positive 0 0 2 18 28 1 

No classification 1 0 0 1 0 3 

Although about 40% of the participants came to a different final conclusion in survey 2010-1, only a minority of 

participants (n=5) classified the sample in 2009-4 as borderline – positive and gave in the 2010-1 survey a 

negative classification. On the other hand, 8 participants who classified the sample normal in the 2009-4 survey, 

classified the sample in the 2010-1 survey as borderline – positive.





Labcode: 900 

LUPUS ANTICOAGULANT (Test plasma 10.06) 

140 

120 

100 

80 

60 

40 

assay type 

. 

other 

SCT 

dPT(TTI) 

dAPTT 

KCT 

Count 

20 

0 

DRVVT 

APTT 

.7 

.8 

.9 

1.0 

1.1 

1.2 

1.3 

1.4 

1.5 

1.6 

1.7 

1.8 

1.9 

2.0 

2.1 

2.2 

> 2.25 

lupus screening 

APTT 

DRVVT 

50 

methods 

100 

methods 

40 

. 

80 

. 

62.0 

107.00 

30 

57.0 

60 

80.00 

20 

45.0 

29.0 

40 

31.00 

27.00 

.7 

.8 

.9 

1.0 

1.1 

1.2 

1.3 

1.4 

1.5 

1.6 

1.7 

1.8 

1.9 

2.0 

2.1 

2.2 

> 2.25 

Count 

10 

0 

21.0 

7.0 

other 

Count 

20 

0 

5.00 

1.00 

other 

.7 

.8 

.9 

1.0 

1.1 

1.2 

1.3 

1.4 

1.5 

1.6 

1.7 

1.8 

1.9 

2.0 

2.1 

2.2 

> 2.25 



SCREENING 

normal 

Border 

line 

Prolonged 

your result 

screening 1 screening 2 screening 3 

APTT 37 20 230 

DRVVT 8 10 326 

KCT 3 2 21 

dAPTT 2 2 19 

dPT(TTI) 4 3 26 

SCT 0 0 11 

other 0 0 2





Labcode: 900 


120 

100 

80 

60 

40 

assay type 

. 

other 

SCT 

dPT(TTI) 

dAPTT 

Count 

20 

0 

KCT 

DRVVT 

APTT 

.60 

.70 

.80 

.90 

1.00 

1.10 

1.20 

1.30 

1.40 

1.50 

1.60 

1.70 

1.80 

1.90 

2.00 

2.10 

2.20 

2.30 

lupus mixing 

MIXING 

normal 

Border 

line 

Prolonged 

your result 

mixing 1 mixing 2 mixing 3 

APTT 46 18 130 

DRVVT 49 32 103 

KCT 11 4 15 

dAPTT 0 2 16 

dPT(TTI) 6 3 14 

SCT 0 1 4 

other 1 0 1





Labcode: 900 


Count 

160 

140 

120 

100 

80 

60 

40 

20 

0 

.70 

.80 

.90 

1.00 

1.10 

1.20 

1.30 

1.40 

1.50 

1.60 

1.70 

1.80 

1.90 

2.00 

2.10 

2.20 

assay type 

. 

SCT 

dPT 

dAPTT 

PNP 

KCT 

DRVVT 

PT 

APTT 

Count 

140 

120 

100 

80 

60 

40 

20 

0 

.70 

.80 

.90 

1.00 

1.10 

1.20 

1.30 

1.40 

1.50 

1.60 

1.70 

1.80 

1.90 

2.00 

2.10 

2.20 

> 2.25 

assay type 

. 

other 

SCT 

dPT 

dAPTT 

PNP 

KCT 

DRVVT 

PT 

APTT 

lupus confirmation 

Ratio Screen / Confirm 

CONFIRMATION 

Positive 

Border- 

Line 

negative 

your result 

confirm 1 confirm 2 confirm 3 

APTT 74 8 10 

PT 5 0 3 

DRVVT 265 42 41 

KCT 2 0 0 

PNP 18 1 10 

dAPTT 16 0 2 

dPT 0 2 3 

SCT 11 0 0 

Other 2 0 0 

RATIO SCREENING/ 

CONFIRMATION 

n mean CV range your result 

ratio 1 ratio 2 ratio 3 

415 1.45 15.2% 0.72 – 2.57 

FINAL 

CONCLUSION 

negative 

Borderline 

weakly 

positive 

positive 

clearly 

positive 

your result 

27 25 64 187 52





Labcode: 900 

ANTICARDIOLIPIN ANTIBODIES 





Responders Number Percentage 

IgG 154 36% 

IgM 137 32% 

Remarks 

1. About 80% of the participants reported their results in GPL or MPL units. Only for those category a histogram was given 

in the report. 

2. Several participants reported a result < [value]. In general the value indicated was included into the statistical 

evaluations with the exception if the value was 5 or higher. 

3. Most of the participants who reported their results in the category “Others” indicated their results in U/mL. 

For most of the methods this seems to be the same as GPL or MPL, because the results in both unit categories are 

comparable. We highly recommend to report according to the unit indicated in the kit insert. 

Overview of methods used for anticardiolipin antibody testing 

IgG IgM 

Code Description No. No. 

2003 Aeskulisa Diagnotic GmbH 2 2 

2076 AIDA 1 1 

2005 Bio-rad 2 2 

2007 BMD Cardiolisa 3 

2008 Cambridge Life Sciences 2 2 

2011 Corgenix Reaads 12 

2015 Diagnostica Stago 1 

2016 Diamedix 1 1 

2017 DiaSorin Inc. 2 2 

2018 Euro Diagnostica 1 

2019 Euroimmun 10 10 

2023 Genisis Diagnostics 1 

2029 IBL 1 

2031 Immuno Cocepts RELISA 1 1 

2032 Imtec GmbH 6 6 

2033 INOVA Diagnostics Inc. 12 11 

2035 Instrumentation Laboratory 1 1 

2045 Louisville APL Diagnostics 3 3 

2055 Orgentec 36 33 

2058 Phadia 21 18 

2060 Pharmacia Diagnostics Varelisa 4 3 

2067 SMC technology 1 1 

2068 The Binding Site 6 6 

2074 Varelisa 8 7 

2075 Vital Diagnostics 3 3 

2090 Homemade 7 5 

2099 Unknown 7 7 

CLASSIFICATION 

Negative Borderline Low positive Medium positive High positive 

No 

conclusion 

IgG 35 14 40 57 7 1 

IgM 135 0 1 1 0 0





Labcode: 900 

ANTICARDIOLIPIN ANTIBODIES 

IgG 

IgM 

50 

70 

40 

30 

20 

60 

50 

40 

30 

Count 

10 

0 

Count 

20 

10 

0 

10.0 

20.0 

30.0 

40.0 

50.0 

60.0 

> 75 

.0 

2.0 

4.0 

6.0 

8.0 

10.0 

12.0 

18.0 

20.0 

> 21 

Anticardiolipin IgG (GPL) 

Anticardiolipin IgM (MPL) 

ANTICARDIOLIPIN (IgG) 


Unit: GPL 

Total Group 122 28.8 109% 0.0 – 280 

INOVA Diagnostics 10 12.0 39.0% 0.0 – 17.0 

Orgentec 28 20.2 19.9% 14.3 – 31.0 

Phadia 20 51.2 10.6% 40.0 – 63.0 

Unit: µg/mL 

Total Group 2 0.70 0.63 – 0.76 

Unit: Other 

Total Group 26 22.2 129% 0.4 – 146.3 

ANTICARDIOLIPIN (IgM) 

n mean CV Range your result 

Unit: MPL 

Total Group 104 3.8 276% 0.0 – 104 

Orgentec 25 2.3 145% 0.9 – 18.0 

Phadia 17 1.2 71.5% 0.1 – 4.2 

Unit: µg/mL 

Total Group 1 0.45 

Unit: Other 

Total Group 21 3.6 152% 0.0 – 23.0 

Remarks: 

Remarkable differences are observed between different methods used for the determination of the 

Anticardiolipin IgG antibodies. This results also in a heterogeneous pattern in the classification of this 

sample. About 23% classified the sample as negative, while the other participants showed a wide variation 

in the classification from borderline to high positive.





Labcode: 900 

ß2-GLYCOPROTEIN I ANTIBODIES 





Responders Number Percentage 

IgG 114 27% 

IgM 95 22% 

Remarks 

1. About 65% if the participants reported their results in U. Only for those category a histogram was given in the report. 

2. Several participants reported a result < [value]. In general the value indicated was included into the statistical 

evaluations with the exception if the value was 5 or higher. 

3. Most of the participants who reported their results in the category “Others” indicated their results in U/mL. 

For most of the methods this seems to be the same as U, because the results in both unit categories are comparable. 

We highly recommend to report according to the unit indicated in the kit insert. 

Overview of methods used for ß2-Glycoprotein I antibody testing 

IgG IgM 

Code Description No. No. 

2003 Aeskulisa Diagnotic GmbH 4 4 

2076 AIDA 1 1 

2005 Bio-rad 3 2 

2011 Corgenix Reaads 11 8 

2018 Euro Diagnostica 1 1 

2019 Euroimmun 9 7 

2032 Imtec GmbH 9 4 

2033 INOVA Diagnostics Inc. 14 13 

2035 Instrumentation Laboratory 1 1 

2055 Orgentec 24 23 

2058 Phadia 18 14 

2060 Pharmacia Diagnostics Varelisa 1 1 

2067 SMC Technology 1 1 

2068 The Binding Site 5 4 

2072 Trinity Biotech 1 1 

2074 Varelisa 2 2 

2090 Homemade 1 3 

2099 Unknown 6 5 

CLASSIFICATION 

Negative Borderline Low positive Medium positive High positive 

No 

conclusion 

IgG 25 8 28 37 15 1 

IgM 93 0 0 0 2 0 

Remarks: There is a remarkable variation in the classification of the ß2-Glycoprotein I IgG antibodies. About 22% 

classified the sample as negative, while the other participants showed a wide variation in the classification 

from borderline to high positive.





Labcode: 900 

ß2-GLYCOPROTEIN I ANTIBODIES 

IgG 

IgM 

40 

30 

30 

20 

20 

10 

10 

Count 

0 

Count 

0 

10.0 

20.0 

30.0 

40.0 

50.0 

80.0 

90.0 

> 95 

.0 

1.0 

2.0 

3.0 

4.0 

5.0 

6.0 

> 9.5 

ß2-Glycoprotein I IgG (U) 

ß2-Glycoprotein I IgM (U) 

ß2-GLYCOPROTEIN I (IgG) 


Unit: U 

Total Group 82 33.3 144% 0.0 – 400 

Orgentec 22 17.4 15.2% 12.6 – 23.3 

Phadia 13 26.0 18.8% 18.0 – 32.0 

Unit: µg/mL 

Total Group 4 14.0 1.4 – 29.8 

Unit: Other 

Total Group 22 23.5 68.9% 1.6 – 71.0 

RATIO 15 2.45 115% 0.5 – 10.5 

ß2-GLYCOPROTEIN I (IgM) 


Unit: U 

Total Group 68 4.0 318% 0.0 – 105 

Orgentec 20 2.8 156% 1.0 – 21.0 

Phadia 11 2.8 57.0% 0.3 – 3.6 

Unit: µg/mL 

Total Group 4 2.1 0.1 – 7.0 

Unit: Other 

Total Group 17 7.8 315% 0.0 - 103 

RATIO 12 1.29 160% 0.1 – 7.0

Survey Report 2010-1 LA.pdf - NASCOLA

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