title: Rapid, automated enzyme immunoassay for MCA with the Cobas Core Roche immunochemistry analyser.
abstract: The breast cancer marker Mucin-like Carcinoma-associated Antigen (MCA) was evaluated in a version that has been adapted to a new enzyme immunoanalyser, the Cobas Core. The two-step sandwich assay has a short total assay time of less than 60 minutes. Standard curves are stable for at least 2 weeks. The coefficients of variation for the inter-assay precision ranged between 3.6% and 7.8%, but were mainly below 5%. Single determinations of patient values from different runs correlated also very closely (R = 0.99). The dilution linearity for a set of 14 sera exhibited recovery rates mostly ranging from 90% to 110%. From 165 blood donors investigated, more than 99% had values below the cut-off of 11 U/ml. As demonstrated for pathological sera, the automated and manual versions showed a high degree of accordance (R = 0.98). The investigation presents convincing evidence that the Cobas Core MCA EIA running on a Cobas Core analyser guarantees a high analytical reliability and reproducibility.
authors.affiliation: Roche Diagnostic Systems, Division of F. Hoffmann-La Roche Ltd., Basle, Switzerland.
authors.forename: V
authors.initials: V
authors.lastname: Henne
authors.forename: A
authors.initials: A
authors.lastname: Maurer
mesh_terms: D000951:Antigens, Neoplasm / Q000097:blood*; D015295:Antigens, Tumor-Associated, Carbohydrate; D014408:Biomarkers, Tumor / Q000097:blood* / Q000276:immunology / Q000592:standards; D001943:Breast Neoplasms / Q000097:blood* / Q000276:immunology; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques / Q000295:instrumentation* / Q000592:standards / Q000706:statistics & numerical data; D012015:Reference Standards; D012016:Reference Values; D015203:Reproducibility of Results
chemical_list: D000951:Antigens, Neoplasm; D015295:Antigens, Tumor-Associated, Carbohydrate; D014408:Biomarkers, Tumor; C057387:mucinous carcinoma-associated antigen