Clinical Chemistry
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Clinical Chemistry 44: 765-772, 1998;
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(Clinical Chemistry. 1998;44:765-772.)
© 1998 American Association for Clinical Chemistry, Inc.

Enzymes and Protein Markers

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

Carol D. Cheli1,a, Deborah L. Morris1, Linda Kish1, Joan Goldblatt1, Irene Neaman1, W. Jeffrey Allard1, Kwok K. Yeung1, Alan H. B. Wu2, Robert Moore2, Daniel W. Chan3, Herbert A. Fritsche4, Morton K. Schwartz5, and Donald L. Very, Jr.1

1 Bayer Corporation, Business Group Diagnostics, Tarrytown, NY 10591.

2 Department of Pathology, Hartford Hospital, Hartford, CT 06102.

3 Johns Hopkins University, Baltimore, MD 21287.

4 M.D. Anderson Cancer Center, Houston, TX 77030.

5 Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
a Address correspondence to this author at: The Institute for Diagnostic Research, Inc., 23 Business Park Dr., Brandford, CT 06405. Fax 203-315-4002; e-mail carol.cheli{at}diabetesdisc.com.

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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Copyright © 1998 by the American Association for Clinical Chemistry.