title: Evaluation of new commercial enzyme-linked immunosorbent assay kits in the laboratory diagnosis of antiphospholipid syndrome in view of the revised classification criteria of the antiphospholipid syndrome.
abstract: Amendments to the Sapporo criteria for the diagnosis of the antiphospholipid syndrome (APS) have recently be published and include testing for the presence of IgG and IgM beta2-glycoprotein I (beta(2)GPI) antibodies. The Asserachrom Antiphospholipid antibodies line (Diagnostica Stago) with a monoclonal based standardisation, was evaluated in a Lupus anticoagulant (LAC) positive (n = 138) and a LAC negative (n = 134) populations. The ELISA line consists of the Asserachrom APA Screen, the Asserachrom APA IgG,M and the Asserachrom anti-beta(2)GPI IgG and IgM. Anti-prothrombin antibodies (APT), not being included in the updated laboratory criteria, have been tested by the Asserachrom anti-prothrombin IgG,M. Imprecision characteristics showed coefficients of variation (CV) ranging from 4.9% to 13.9%. Cut-off values were calculated with the 99 percentile. The Asserachrom APA Screen showed 1,5% false positive and 0,7% false negative results in correlation with the Asserachrom APA IgG,M. 14.7% of the patients were positive for beta2GPI antibodies, 30,0% of them showed a negative Asserachrom APA Screen. beta(2)GPI antibodies may be the only test positive in a minority of patients, so the Asserachrom APA Screen and the Asserachrom anti-beta(2)GPI IgG and IgM should be performed in parallel when APS is suspected. LAC and APA assays, however, remain essential in the laboratory diagnosis of APS.
authors.affiliation: Coagulation Laboratory, Department of Clinical Chemistry, Microbiology and Immunology, Ghent University Hospital, Ghent, Belgium. katrien.devreese@uzgent.be
authors.forename: Katrien Mj
authors.initials: KM
authors.lastname: Devreese
mesh_terms: D017153:Antibodies, Anticardiolipin / Q000097:blood*; D016736:Antiphospholipid Syndrome / Q000145:classification / Q000175:diagnosis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation*; D005188:False Negative Reactions; D005189:False Positive Reactions; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis; D007075:Immunoglobulin M / Q000032:analysis; D016682:Lupus Coagulation Inhibitor / Q000097:blood*; D011516:Prothrombin / Q000276:immunology; D053482:beta 2-Glycoprotein I / Q000276:immunology
chemical_list: D017153:Antibodies, Anticardiolipin; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D016682:Lupus Coagulation Inhibitor; D053482:beta 2-Glycoprotein I; D011516:Prothrombin