title: Evaluation of the IMMULITE BR-MA and CEA assays and comparison with immunoradiometric assays for CA15-3 and CEA in breast cancer.
abstract: This study was designed to evaluate the performance of a new automated assay system, the IMMULITE Automated Immunoassay Analyzer in comparison with more commonly used IRMA assays for measuring circulating tumour marker levels in breast cancer patients. The assays investigated measure the MUC1 mucin (CA15-3 antigen) or CEA. Serum samples from breast cancer patients with various stages of disease and from a group of normal individuals were analysed. Significant correlations were found between tumour marker levels measured using the IMMULITE BR-MA and the CA15-3 assays and between levels measured using the two CEA assay formats. Levels of IMMULITE BR-MA and CEA correlated with stage of disease suggesting that both are markers of tumour burden Levels in Stage III breast cancer patients were found to be significantly higher than those of normals using the IMMULITE system but not the IRMA assays. This would suggest a role for the automated system in the monitoring of breast cancer at an earlier stage than that at which tumour markers are routinely used. Elevated marker levels did not correspond to any particular site of metastasis however, a greater proportion of patients with multiple sites of metastasis had elevated levels compared with those with secondary disease at a single site. We conclude that the IMMULITE Automated Immunoassay Analyzer is of value in the routine surveillance of tumour marker levels.
authors.affiliation: Department of Pharmaceutical Sciences, University of Nottingham, University Park, UK. paxam@panl.pharm.nottingham.ac.uk
authors.forename: A
authors.initials: A
authors.lastname: Murray
authors.forename: P
authors.initials: P
authors.lastname: Willsher
authors.forename: M R
authors.initials: MR
authors.lastname: Price
authors.forename: A R
authors.initials: AR
authors.lastname: Dixon
authors.forename: J F
authors.initials: JF
authors.lastname: Robertson
mesh_terms: D001331:Automation; D001943:Breast Neoplasms / Q000097:blood* / Q000175:diagnosis* / Q000473:pathology; D002272:Carcinoembryonic Antigen / Q000097:blood*; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D015592:Immunoradiometric Assay / Q000379:methods; D018396:Mucin-1 / Q000097:blood*; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D012016:Reference Values; D012044:Regression Analysis; D015203:Reproducibility of Results
chemical_list: D002272:Carcinoembryonic Antigen; D018396:Mucin-1