Multicenter evaluation of the Bayer Immuno 1(TM) CA 15-3(TM) assay

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Abstract

We conducted a multicenter evaluation of the analytical and clinical features of the automated Bayer Immuno 1(TM) CA 15-3(TM) assay and compared assay performance to two manual tests. Results of the 10-day imprecision study of the Bayer Immuno 1 assay pooled across four evaluation sites and three lots of reagent produced total CV ≤4%. Lot-to-lot reproducibility for 26 different lots of reagents and calibrators manufactured over a 2-year period was demonstrated (CV, 1.1%). Results for the Bayer Immuno 1 assay correlated well with the Biomira TRUQUANT® BR(TM) 27.29 and Centocor® CA 15-3 RIAs (r ≤0.94). The upper limit of the reference interval for the Bayer Immuno 1 assay was 35.9 kilounits/L (35.9 units/mL); values were similar for all methods. Longitudinal monitoring of healthy women yielded assay values with an average CV of 11% and 21% for the Bayer Immuno 1 and Biomira assays, respectively. The Bayer Immuno 1 assay demonstrated the analytical features, intermethod correlation, and long-term performance characteristics that are essential for longitudinal monitoring of breast cancer patients.

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Cheli, C. D., Morris, D. L., Kish, L., Goldblatt, J., Neaman, I., Allard, W. J., … Very, D. L. (1998). Multicenter evaluation of the Bayer Immuno 1(TM) CA 15-3(TM) assay. Clinical Chemistry, 44(4), 765–772. https://doi.org/10.1093/clinchem/44.4.765

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