Biomedical subjects
Publications and source records attributed to A P Durham.
Recently Musto et al. (Clin Chem 30: 329-330, 1984) noted that, despite the clinical importance of accurate measurement of thyrotropin at low concentrations, the upper limit of normal is well below the stated upper limit of normal of most commercial tests. Here I amplify their statement.
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BACKGROUND: The array of antibodies and assay formats utilised by kit manufacturers contribute to different values being quoted as clinically "normal". Kit-specific reference range limits will maximise the clinical utility of tumour marker assays. MATERIALS AND METHODS: Serum samples (approximately 800) were obtained from volunteers, age 20-70 years, in France, Germany, The Netherlands and Portugal. Each sample was assayed with a number of DPC tumour markers kits. IMMULITE assays were carried out in The Netherlands; Coat-A-Count IRMA, IRMA-Count, Double Antibody and Milenia assays at EURO/DPC Ltd. Analytes included, BR-MA, OM-MA, GI-MA (for the determination of CA 15-3, CA 125 and CA 19-9, respectively), CEA, PSA, PAP and HCG. RESULTS: The median and 95th percentiles for each analyte in each assay format were estimated; where appropriate, data subsets were considered. CONCLUSION: Kit-specific reference range data generated for important tumour marker analytes will help clinicians interprete their assay results.