A multi-centre evaluation of the intra-assay and inter-assay variation of commercial and in-house anti-cardiolipin antibody assays

Richard Wong; Emmanuel Favaloro; Wendy Pollock; Robert Wilson; Michelle Hendle; Stephen Adelstein; Karl Baumgart; Paul Homes; Stuart Smith; Richard Steele; Allan Sturgess; David Gillis

doi:10.1080/00313020410001672037

A multi-centre evaluation of the intra-assay and inter-assay variation of commercial and in-house anti-cardiolipin antibody assays

Richard Wong, Emmanuel Favaloro, Wendy Pollock, Robert Wilson, Michelle Hendle, Stephen Adelstein, Karl Baumgart, Paul Homes, Stuart Smith, Richard Steele, Allan Sturgess, David Gillis

Dentistry and Medical Sciences

Princess Alexandra and Royal Brisbane Hospitals

Research output: Contribution to journal › Article › peer-review

46 Citations (Scopus)

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.

Original language	English
Pages (from-to)	182-92
Number of pages	11
Journal	Pathology
Volume	36
Issue number	2
DOIs	https://doi.org/10.1080/00313020410001672037
Publication status	Published - Apr 2004

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title = "A multi-centre evaluation of the intra-assay and inter-assay variation of commercial and in-house anti-cardiolipin antibody assays",

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.",

keywords = "Antibodies, Anticardiolipin/analysis, Australia, Clinical Laboratory Techniques/standards, Consensus, Enzyme-Linked Immunosorbent Assay/standards, Humans, Immunoglobulin G/analysis, Immunoglobulin M/analysis, Laboratories/standards, Quality Assurance, Health Care, Reagent Kits, Diagnostic/standards, Reproducibility of Results",

author = "Richard Wong and Emmanuel Favaloro and Wendy Pollock and Robert Wilson and Michelle Hendle and Stephen Adelstein and Karl Baumgart and Paul Homes and Stuart Smith and Richard Steele and Allan Sturgess and David Gillis",

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doi = "10.1080/00313020410001672037",

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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

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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.

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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

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JO - Pathology

JF - Pathology

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ER -

A multi-centre evaluation of the intra-assay and inter-assay variation of commercial and in-house anti-cardiolipin antibody assays

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