title: 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.
  
  
  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.
  
  
  CONCLUSIONS
  Kit-specific reference range data generated for important tumour marker analytes will help clinicians interprete their assay results.
authors.affiliation: EURO/DPC Ltd, Llanberis, Caernarfon, Gwynedd, Wales, UK.
authors.forename: A P
authors.initials: AP
authors.lastname: Wilson
authors.forename: A
authors.initials: A
authors.lastname: Van Dalen
authors.forename: P E
authors.initials: PE
authors.lastname: Sibley
authors.forename: L A
authors.initials: LA
authors.lastname: Kasper
authors.forename: A P
authors.initials: AP
authors.lastname: Durham
authors.forename: A S
authors.initials: AS
authors.lastname: el Shami
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D014408:Biomarkers, Tumor / Q000097:blood*; D018394:CA-125 Antigen / Q000097:blood; D018395:CA-19-9 Antigen / Q000097:blood; D002272:Carcinoembryonic Antigen / Q000097:blood; D006063:Chorionic Gonadotropin / Q000097:blood; D005260:Female; D005602:France; D005858:Germany; D006801:Humans; D015592:Immunoradiometric Assay / Q000295:instrumentation / Q000379:methods; D008297:Male; D008875:Middle Aged; D018396:Mucin-1 / Q000097:blood; D009426:Netherlands; D011174:Portugal; D017430:Prostate-Specific Antigen / Q000097:blood; D011933:Reagent Kits, Diagnostic; D012016:Reference Values; D012727:Sex Characteristics; D012907:Smoking
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D018395:CA-19-9 Antigen; D002272:Carcinoembryonic Antigen; D006063:Chorionic Gonadotropin; D018396:Mucin-1; D011933:Reagent Kits, Diagnostic; D017430:Prostate-Specific Antigen