Multicentre tumour marker reference range study.

ABSTRACT

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.