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^R 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 EI A running on a Cobas^R Core analyser guarantees a high analytical reliability and reproducibility.