TY - JOUR
T1 - A multi-centre evaluation of the intra-assay and inter-assay variation of commercial and in-house anti-cardiolipin antibody assays
AU - Wong, Richard
AU - Favaloro, Emmanuel
AU - Pollock, Wendy
AU - Wilson, Robert
AU - Hendle, Michelle
AU - Adelstein, Stephen
AU - Baumgart, Karl
AU - Homes, Paul
AU - Smith, Stuart
AU - Steele, Richard
AU - Sturgess, Allan
AU - Gillis, David
PY - 2004/4
Y1 - 2004/4
N2 - 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.
AB - 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.
KW - Antibodies, Anticardiolipin/analysis
KW - Australia
KW - Clinical Laboratory Techniques/standards
KW - Consensus
KW - Enzyme-Linked Immunosorbent Assay/standards
KW - Humans
KW - Immunoglobulin G/analysis
KW - Immunoglobulin M/analysis
KW - Laboratories/standards
KW - Quality Assurance, Health Care
KW - Reagent Kits, Diagnostic/standards
KW - Reproducibility of Results
U2 - 10.1080/00313020410001672037
DO - 10.1080/00313020410001672037
M3 - Article
C2 - 15203756
SN - 0031-3025
VL - 36
SP - 182
EP - 192
JO - Pathology
JF - Pathology
IS - 2
ER -