Consensus guidelines on anti-beta 2 glycoprotein I testing and reporting

SummaryConsensus guidelines on anti-beta 2 glycoprotein I (anti-β2GPI) testing have been developed to help minimise laboratory variation in the performance and reporting of assays for these antibodies. These guidelines include minimum and optional recommendations for the following aspects of anti-β2GPI testing and reporting: (1) isotype of anti-β2GPI tested; (2) specimen type; (3) controls and assay precision; (4) calibrators; (5) patient samples; (6) rheumatoid factors and IgM anti-β2GPI testing; (7) reporting of results; (8) cutoff values; and (9) interpretative comments. Issues related to inter-kit/assay standardisation and the manufacturing process of commercial anti-β2GPI kits/assays have not been addressed in the current guidelines.