A multi-centre evaluation of the intra-assay and inter-assay variation of commercial and in-house anti-cardiolipin antibody assays.
Pathology
; 36(2): 182-92, 2004 Apr.
Article
in En
| MEDLINE
| ID: mdl-15203756
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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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Quality Assurance, Health Care
/
Reagent Kits, Diagnostic
/
Antibodies, Anticardiolipin
/
Clinical Laboratory Techniques
/
Laboratories
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Limits:
Humans
Country/Region as subject:
Oceania
Language:
En
Journal:
Pathology
Year:
2004
Document type:
Article
Affiliation country:
Australia
Country of publication:
United kingdom