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Multi-site evaluation of a chemiluminescent Rubella IgM assay for the ADVIA CentaurTM



Multi-site evaluation of a chemiluminescent Rubella IgM assay for the ADVIA CentaurTM



Abstracts of the General Meeting of the American Society for Microbiology 101: 185



This study reports the findings of a multi-site evaluation of a chemiluminescent immunoassay for the detection of IgM antibodies to Rubella virus in human serum with the automated ADVIA Centaur analyzer. The evaluation included method comparison for the determination of clinical efficacy and assay precision. The assay is a paramagnetic microparticle antibody class capture assay utilizing monoclonal anti-human IgM antibody, and purified Rubella antigen. The assay requires a 20 mul serum sample and the total incubation time is 36 minutes with a maximum throughput of 120 results per hour. Results are reported as an index value relative to a standard curve with a cut-off index of 1.0. 1054 prenatal and hospital patient samples at three clinical sites were tested with the ADVIA Centaur Rubella IgM assay. Additionally, 107 specimens with potentially interfering substances, including multiple myeloma, rheumatoid factor and other infections were tested. After resolution with other commercially available EIAs, assay sensitivity was 97.2% and assay specificity was 99.5%. Using the NCCLS EP5-T2 precision protocol, the ADVIA Centaur Rubella IgM assay had a total %CV of less than 7% over the assay range. In conclusion, the ADVIA Centaur Rubella IgM assay is a consistent and precise immunoassay for the detection of IgM antibodies to Rubella.

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Accession: 035349518

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