Multicentre tumour marker reference range study.
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.
Wilson
A P
AP
EURO/DPC Ltd, Llanberis, Caernarfon, Gwynedd, Wales, UK.
Van Dalen
A
A
Sibley
P E
PE
Kasper
L A
LA
Durham
A P
AP
el Shami
A S
AS
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
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