LUPUS ANTICOAGULANT LABORATORY CODE NUMBER: 900

Transcription

1 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 1 of 12 LUPUS ANTICOAGULANT LABORATORY CODE NUMBER: 9 Test plasma : 1.6 Type of plasma : Low Lupus Inhibitor Plasma (Technoclone, lot no. 2U92A). Former used in exercise : 9-4 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 1) 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 1) 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 > 1% 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.

2 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 2 of 12 Overview of methods used for lupus anticoagulant testing Screen Mix Confirm Code Description No. No. No. 2 American Diagnostica DVVconfirm American Diagnostica DVVtest American Diagnostica ActiClot dpt AMAX Accuclot drvvt screen AMAX Accuclot drvvt confirm 1 14 BDH Kaolin light 18 Biodata Corporation Platelet extract reagent 12 Biopep: LA check 13 Biopep: LA sure 96 Dialab APTT-SMA 2 23 Diagen BeA 37 Diagen Dia PTT 24 Diagen KPS 112 Diagen Micronised Silica APTT 1 7 Diagen RVV 119 Diagnostic Lupotek KCT reagent 87 Enzyme Research R2 Diagnostics Haemachrom KCT Haematex SACT reagent 1 76 Helena BioSciences DRVVT confirm 1 75 Helena Biosciences DRVVT screen 78 Helena/Ortho Synth. A Fax 89 Hemoliance SynthaFax 79 Hemoliance Synthasil APTT Hemoliance Thrombosil 69 Homemade Kaolin Homemade Platelet Lysate Hyphen Biomed Cephen 1LS I.L. APTT Lyophilized Silica I.L. APTT SP I.L. HemosIL Recombiplastin I.L. HemosIL SynthASil I.L. HemosIL SynthAFax I.L. LAC confirm I.L. LAC screen I.L. MixCon I.L. PT-Fibrinogen Recombinant 14 I.L. SCT screen I.L. SCT confirm Immuno Dapttin 2 33 Immuno Lupus Anticoagulant Test 1 Kaogen KaoTime 121 Kaolup Confirm 1 35 Kordia LAC kit (Unicorn) 36 Kordia RVV-X C1(rabbit cefaline) 25 Life Diagnostic Gradilin 26 Life Diagnostic Kaoclot Life Diagnostic LA confirm Life Diagnostic LA screen Manchester Diagnostics DRVVT reagents 4 Nycomed Cephotest 41 Nycomed Nycoplastin 1 5 Ortho Recombiplastin 51 Ortho Synthasil Precision Biologic LA check Precision Biologic LA sure Precision Biologic Platelet Lysate 7

3 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 3 of 12 Screen Mix Confirm Code Description No. No. No. 77 R 2 Diagnostics DRVVT confirm 11 R 2 Diagnostics DRVVT screen R 2 Diagnostics LupoTek KCT Renam APTT 74 Renam drvvt confirm 73 Renam drvvt screen 71 Renam Erilyrd-Kaolin 72 Renam Renamplastin 19 Siemens Actin 1 1 Siemens Actin FS Siemens Actin FSL Siemens Innovin Siemens LA1 screen Siemens LA2 confirmation Siemens Pathromtin SL Siemens Thromboplastin C+ 85 Siemens Thromborel R 8 Siemens Thromborel S Siemens ProC Global 1 66 Stago / Roche APTT Kaolin 93 Stago / Roche Cephascreen 1 66 Stago / Roche CKPrest / Kaolin Stago / Roche DRVVT confirm Stago / Roche DRVVT screen Stago / Roche Neoplastin CI 1 11 Stago / Roche Neoplastin R 67 Stago / Roche Neoplastin Cl Stago / Roche PTT Automate / STA APTT Stago / Roche PTT LA Stago / Roche SPA5 58 Stago / Roche Staclot LA Technoclone Lupus Anticoagulant Test Technoclone LA Screen 1 83 Trinity Biotech Accuclot DRVVT confirm 1 82 Trinity Biotech Accuclot DRVVT screen Trinity Biotech Amax Alexin 13 Trinity Biotech Amax Alexin HS 52 Trinity Biotech APTT 1 46 Trinity Biotech Automated APTT Trinity Biotech Bioclot LA 1 Trinity Biotech Hemolab Silimat 84 Trinity Biotech Kaolin Trinity Biotech Platelin L Trinity Biotech Platelin LS Trinity Biotech RVV 44 Trinity Biotech Simplastin Trinity Biotech Simplastin HTF 118 Trinity Biotech TriniClot APTT-HS Trinity Biotech TriniClot APTT-S 1 48 Trinity Biotech Viperquik LA-check 47 Trinity Biotech Viperquik LA-Test 65 Unicorn DRVVT Unichrom LA-DRVVT 116 Vital Diagnostics Vitaclot Unknown

4 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 4 of 12 Overview ratio ECAT plasma / normal plasma RATIO SCREENING n mean CV Range APTT % APTT SP (IL) % HemosIL SynthASil (IL) % Pathromtin SL (Siemens) % Actin FSL (Siemens) % PTT Automate / STA APTT (Stago) % PTT LA (Stago) % DRVVT % DVVtest (AD) % LAC screen (I.L.) % LA screen (Life Diagnostics) % LA check (Precision Biologic) % LA1 screen (Siemens) % DRVVT Screen (Stago) % KCT % daptt % dpt % Innovin (Siemens) % Acticlot dpt (AD) % SCT % Other 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 % APTT SP (IL) % Pathromtin SL (Siemens) % Actin FSL (Siemens) % PTT LA (Stago) % DRVVT % LAC screen (I.L.) % LA screen (Life Diagnostics) % LA1 screen (Siemens) % DRVVT Screen (Stago) % KCT % daptt % dpt % Innovin (Siemens) % SCT Other

5 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 5 of 12 RATIO CONFIRMATION n mean CV range APTT % Actin FS (Siemens) % PT DRVVT % DVV Confirm (AD) % LAC confirm (I.L.) % LA confirm (Life Diagnostics) % LA Sure (Precision Biologic) % LA2 confirmation (Siemens) % DRVVT Confirm (Stago) % KCT PNP % daptt dpt SCT % Comparison classification survey 9-4 and 1-1 In this survey the same sample was distributed as in survey 9-4. 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 Normal Borderline Weakly Positive Positive Strongly Positive No classification Normal Borderline Weakly Positive Positive Strongly Positive No classification Although about 4% of the participants came to a different final conclusion in survey 1-1, only a minority of participants (n=5) classified the sample in 9-4 as borderline positive and gave in the 1-1 survey a negative classification. On the other hand, 8 participants who classified the sample normal in the 9-4 survey, classified the sample in the 1-1 survey as borderline positive.

6 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 6 of 12 LUPUS ANTICOAGULANT (Test plasma 1.6) assay type. other SCT dpt(tti) daptt KCT DRVVT APTT > 2.25 lupus screening APTT DRVVT 5 methods 1 methods > other other > 2.25 lupus screening lupus screening SCREENING normal Border line Prolonged your result screening 1 screening 2 screening 3 APTT DRVVT KCT daptt dpt(tti) SCT 11 other 2

7 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 7 of 12 LUPUS ANTICOAGULANT (Test plasma 1.6) assay type. other SCT dpt(tti) daptt KCT DRVVT APTT lupus mixing MIXING normal Border line Prolonged your result mixing 1 mixing 2 mixing 3 APTT DRVVT KCT daptt 2 16 dpt(tti) SCT 1 4 other 1 1

8 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 8 of 12 LUPUS ANTICOAGULANT (Test plasma 1.6) assay type. SCT dpt daptt PNP KCT DRVVT PT APTT > 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 PT 5 3 DRVVT KCT 2 PNP daptt 16 2 dpt 2 3 SCT 11 Other 2 RATIO SCREENING/ CONFIRMATION n mean CV range your result ratio 1 ratio 2 ratio % FINAL CONCLUSION negative Borderline weakly positive positive clearly positive your result

9 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 9 of 12 ANTICARDIOLIPIN ANTIBODIES Test plasma : 1.6 Type of plasma : Low Lupus Inhibitor Plasma (Technoclone, lot no. 2U92A). Former used in exercise : 9-4 Number of participants : 429 Responders Number Percentage IgG % IgM % Remarks 1. About 8% 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. 3 Aeskulisa Diagnotic GmbH AIDA Bio-rad BMD Cardiolisa 3 8 Cambridge Life Sciences Corgenix Reaads Diagnostica Stago 1 16 Diamedix DiaSorin Inc Euro Diagnostica 1 19 Euroimmun Genisis Diagnostics 1 29 IBL 1 31 Immuno Cocepts RELISA Imtec GmbH INOVA Diagnostics Inc Instrumentation Laboratory Louisville APL Diagnostics Orgentec Phadia Pharmacia Diagnostics Varelisa SMC technology The Binding Site Varelisa Vital Diagnostics Homemade Unknown 7 7 CLASSIFICATION Negative Borderline Low positive Medium positive High positive No conclusion IgG IgM

10 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 1 of 12 ANTICARDIOLIPIN ANTIBODIES IgG IgM > > 21 Anticardiolipin IgG (GPL) Anticardiolipin IgM (MPL) ANTICARDIOLIPIN (IgG) n mean CV range your result Unit: GPL Total Group %. 28 INOVA Diagnostics %. 17. Orgentec % Phadia % Unit: µg/ml Total Group Unit: Other Total Group % ANTICARDIOLIPIN (IgM) n mean CV Range your result Unit: MPL Total Group %. 14 Orgentec % Phadia % Unit: µg/ml Total Group 1.45 Unit: Other Total Group %. 23. 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.

11 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 11 of 12 ß2-GLYCOPROTEIN I ANTIBODIES Test plasma : 1.6 Type of plasma : Low Lupus Inhibitor Plasma (Technoclone, lot no. 2U92A). Former used in exercise : 9-4 Number of participants : 429 Responders Number Percentage IgG % 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. 3 Aeskulisa Diagnotic GmbH AIDA Bio-rad Corgenix Reaads Euro Diagnostica Euroimmun Imtec GmbH INOVA Diagnostics Inc Instrumentation Laboratory Orgentec Phadia Pharmacia Diagnostics Varelisa SMC Technology The Binding Site Trinity Biotech Varelisa Homemade Unknown 6 5 CLASSIFICATION Negative Borderline Low positive Medium positive High positive No conclusion IgG IgM 93 2 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.

12 INTERNATIONAL EXTERNAL QUALITY ASSESSMENT Page 12 of 12 ß2-GLYCOPROTEIN I ANTIBODIES IgG IgM > > 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 %. 4 Orgentec % Phadia % Unit: µg/ml Total Group Unit: Other Total Group % RATIO % ß2-GLYCOPROTEIN I (IgM) n mean CV range your result Unit: U Total Group %. 15 Orgentec % Phadia % Unit: µg/ml Total Group Unit: Other Total Group % RATIO %.1 7.