The confirmation of diagnosis of the Antiphospholipid Syndrome (APS) relies on laboratory tests. Current classification criteria for definite APS mandate the use of three "standardized" laboratory assays to detect antiphospholipid antibodies (aPL) [viz: anticardiolipin (aCL) IgG and IgM, anti-β(2) glycoprotein I (anti-β(2) GPI) antibodies IgG and IgM and/or a lupus anticoagulant (LAC)], when at least one of the two major clinical manifestations (thrombosis or pregnancy losses) are present. Although International Consensus Guidelines for the determination of LAC have been published and revised, the existence of "standardized" tests for detection of aCL and anti-β(2) GPI has remained elusive. In spite of the publication of several proposals, consensus documents and expert opinions, significant inter-assay and inter-laboratory variation in the results of both aCL and anti-β(2) GPI testing still exists, which affects the consistency of the diagnosis of APS. At the 13(th) International Congress on Antiphospholipid Antibodies (April 13-16, 2010, Galveston, TX), a Task Force of scientists and pioneers in the field from different countries recognized that although different groups have independently published protocols for the determination of the widely used aCL test - described for the first time in 1983 - and the anti-β(2) GPI - described first the early 1990's - International Consensus Guidelines for those tests are still lacking and urgently needed. The group has worked on developing recommendations outlining basic technical and performance characteristics of immunoassays for the measurement of aCL and anti-β(2) GPI. The overall purpose of this effort was to provide clinical laboratories, manufacturers and kit developers with state-of-the art recommendations and expectations on best practices regarding aCL and anti-β(2) GPI testing as well as harmonization of these guidelines with regulatory requirements.
International consensus guidelines on anticardiolipin and anti-β(2) glycoprotein I testing : a report from the APL task force at the 13th international congress on antiphospholipid antibodies / G. Lakos, E. J. Favaloro, E. N. Harris, P. Meroni, A. Tincani, R. C. Wong, S. S. Pierangeli. - In: ARTHRITIS AND RHEUMATISM. - ISSN 0004-3591. - 64:1(2012 Jan), pp. 1-10.
International consensus guidelines on anticardiolipin and anti-β(2) glycoprotein I testing : a report from the APL task force at the 13th international congress on antiphospholipid antibodies
P. Meroni;
2012
Abstract
The confirmation of diagnosis of the Antiphospholipid Syndrome (APS) relies on laboratory tests. Current classification criteria for definite APS mandate the use of three "standardized" laboratory assays to detect antiphospholipid antibodies (aPL) [viz: anticardiolipin (aCL) IgG and IgM, anti-β(2) glycoprotein I (anti-β(2) GPI) antibodies IgG and IgM and/or a lupus anticoagulant (LAC)], when at least one of the two major clinical manifestations (thrombosis or pregnancy losses) are present. Although International Consensus Guidelines for the determination of LAC have been published and revised, the existence of "standardized" tests for detection of aCL and anti-β(2) GPI has remained elusive. In spite of the publication of several proposals, consensus documents and expert opinions, significant inter-assay and inter-laboratory variation in the results of both aCL and anti-β(2) GPI testing still exists, which affects the consistency of the diagnosis of APS. At the 13(th) International Congress on Antiphospholipid Antibodies (April 13-16, 2010, Galveston, TX), a Task Force of scientists and pioneers in the field from different countries recognized that although different groups have independently published protocols for the determination of the widely used aCL test - described for the first time in 1983 - and the anti-β(2) GPI - described first the early 1990's - International Consensus Guidelines for those tests are still lacking and urgently needed. The group has worked on developing recommendations outlining basic technical and performance characteristics of immunoassays for the measurement of aCL and anti-β(2) GPI. The overall purpose of this effort was to provide clinical laboratories, manufacturers and kit developers with state-of-the art recommendations and expectations on best practices regarding aCL and anti-β(2) GPI testing as well as harmonization of these guidelines with regulatory requirements.
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