Multicentre tumour marker reference range study

Anticancer Res. 1999 Jul-Aug;19(4A):2749-52.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Biomarkers, Tumor / blood*
  • CA-125 Antigen / blood
  • CA-19-9 Antigen / blood
  • Carcinoembryonic Antigen / blood
  • Chorionic Gonadotropin / blood
  • Female
  • France
  • Germany
  • Humans
  • Immunoradiometric Assay / instrumentation
  • Immunoradiometric Assay / methods
  • Male
  • Middle Aged
  • Mucin-1 / blood
  • Netherlands
  • Portugal
  • Prostate-Specific Antigen / blood
  • Reagent Kits, Diagnostic
  • Reference Values
  • Sex Characteristics
  • Smoking

Substances

  • Biomarkers, Tumor
  • CA-125 Antigen
  • CA-19-9 Antigen
  • Carcinoembryonic Antigen
  • Chorionic Gonadotropin
  • Mucin-1
  • Reagent Kits, Diagnostic
  • Prostate-Specific Antigen