Survey Report 2010-1 LA.pdf - NASCOLA

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PROGRAMME IN HAEMOSTASIS AND THROMBOSIS Print date: 08 June 2010
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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.

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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

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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

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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

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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.

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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
lupus screening
lupus screening
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

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Labcode: 900
LUPUS ANTICOAGULANT (Test plasma 10.06)
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

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Labcode: 900
LUPUS ANTICOAGULANT (Test plasma 10.06)
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

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Labcode: 900
ANTICARDIOLIPIN ANTIBODIES
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
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

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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)
n mean CV range your result
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.

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Labcode: 900
ß2-GLYCOPROTEIN I ANTIBODIES
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
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.

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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)
n mean CV range your result
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)
n mean CV range your result
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