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Performance of two new, automated chemiluminescence assay panels for anticardiolipin and anti‐beta2‐glycoprotein I antibodies in the laboratory diagnosis of the antiphospholipid syndrome
Author(s) -
Van Hoecke F.,
Persijn L.,
Decavele A.S.,
Devreese K.
Publication year - 2012
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/j.1751-553x.2012.01448.x
Subject(s) - antiphospholipid syndrome , medicine , antibody , odds ratio , immunology , population , anticardiolipin antibodies , cohort , chemiluminescence , lupus anticoagulant , glycoprotein , gastroenterology , biology , microbiology and biotechnology , chemistry , organic chemistry , environmental health
Summary Introduction Anticardiolipin ( aCL ) and anti‐β2‐glycoprotein I ( aβ 2 GPI ) antibodies are two of the three laboratory criteria for antiphospholipid syndrome ( APS ). All assays for antiphospholipid antibodies ( aPL ), coagulation assays as well as ELISAs , show methodological shortcomings, which makes the search for better assays everlasting. The purpose of this study was to investigate the diagnostic performance of two new, fully automated systems ( Z enit RA and H emos IL A custar) applying chemiluminescent technology for aPL detection. Methods The study cohort consisted of a patient population presenting with thrombosis. In such patient population, the demonstration of aPL determines whether a patient has APS or not with implications for treatment. One hundred and twenty‐four patients with thrombotic complications, of whom 26 were patients with definite APS , were integrated in this study. Besides, aPL titres were compared to the S apporo standards. Results Results of both systems agreed well with ELISA and mutually. Analysis of the discrepant results between Z enit and A custar finally led to one misclassification as APS . Conclusion Diagnostic performances of both Z enit RA and HemosIL Acustar were comparable with odds ratios lower limits of CI of 5 for aβ 2 GPI IgG for Z enit and A custar and 6 and 5 for aCl IgG on Z enit and A custar, respectively. However, even with these new automated systems, titres differed largely between systems, especially for aβ 2 GPI IgG .