Abstract
Aims: To assess the intra‐assay (intra‐run) and inter‐assay (inter‐run) variation of commercial and in‐house IgG and IgM anti‐cardiolipin antibody (aCL) assays/kits, and to determine an appropriate maximum value for inclusion in consensus guidelines.
Methods: Frozen aliquots of two patient specimens and one commercial control were sent to nine laboratories for the evaluation of eight commercial kits and one in‐house assay. Intra‐assay and inter‐assay evaluations were performed with all three samples for IgG aCL, and one patient specimen for IgM aCL.
Results: The IgG and IgM aCL values varied considerably between the nine assays/kits. The majority of assays/kits demonstrated less than 20% intra‐assay and inter‐assay variation, with lower intra‐assay and inter‐assay variation observed with the commercial control. Single calibrator assays were not consistently associated with higher inter‐assay variation than multi‐point calibrator assays.
Conclusions: An inter‐assay coefficient of variation of 20% was determined to be an appropriate maximum value for inclusion in the Australasian aCL Working Party consensus guidelines. Improved standardisation between different assay/kits is still required.