A Review of β2-Glycoprotein-I Antibody Testing Results From a Peer-Driven Multilaboratory Quality Assurance Program

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Abstract

We evaluated the results of IgG β2-glycoprotein-I (B2GPI) antibody assays in a multilaboratory setting by analyzing data from an external quality assurance program for the 2003 through 2005 cycles for 27 serum samples, including quantitative IgG-B2GPI values and qualitative interpretation and grading (ie, negative or positive; grade of positivity), according to method type and in conjunction with clinical data. We report high interlaboratory variation in numeric IgG-B2GPI results, comparable to that reported for IgG anticardiolipin antibody (aCL) testing, and some method-based variation. For example, interlaboratory coefficients of variation for IgG-B2GPI were more than 50% in 19 samples (70%). For qualitative reporting, there was generally better consensus than previously reported for semiquantitative IgG-aCL testing; although 100% consensus occurred for only 11 samples (41%), more than 90% of laboratories agreed for 19 samples (70%). In some cases, laboratory findings (negative or positive IgG-B2GPI) did not agree with clinical information. Despite the lack of formal standardization for IgG-B2GPI testing compared with IgG-aCL, there seems to be better cross-laboratory consensus. Improvement in standardization of these assays is still required to improve interlaboratory and intermethod concordance of results and interpretation between laboratories and the clinical usefulness of IgG-B2GPI testing.

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