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Published on: December 12, 2011
Multicenter evaluation of the Bayer Immuno I CA 15-3 assay
C D Cheli1, D L Morris, L Kish
1Bayer Corporation, Business Group Diagnostics, Tarrytown, NY 10591, USA. carol.cheli@diabetesdisc.com
Clinical Chemistry
|April 29, 1998
Summary
The automated Bayer Immuno 1 assay shows excellent precision and reproducibility for CA 15-3 testing. This assay is suitable for monitoring breast cancer patients due to its analytical performance and correlation with other methods.
Area of Science:
- Clinical Chemistry
- Immunoassays
- Biomarkers
Background:
- CA 15-3 is a tumor marker frequently used in breast cancer monitoring.
- Automated immunoassays offer potential advantages in efficiency and standardization over manual methods.
Purpose of the Study:
- To evaluate the analytical and clinical performance of the automated Bayer Immuno 1 CA 15-3 assay.
- To compare the Bayer Immuno 1 assay's performance against two established manual assays.
Main Methods:
- Multicenter evaluation involving four sites and multiple reagent lots.
- Imprecision studies over 10 days and lot-to-lot reproducibility over 2 years.
- Correlation analysis with Biomira TRUQUANT BR 27.29 and Centocor CA 15-3 RIAs.
Main Results:
- Total coefficient of variation (CV) for the Bayer Immuno 1 assay was ≤4% during imprecision studies.
- Lot-to-lot reproducibility demonstrated a CV of 1.1%.
- Excellent correlation (r ≥ 0.94) was observed between the Bayer Immuno 1 assay and manual RIAs.
Conclusions:
- The Bayer Immuno 1 assay exhibits robust analytical performance, including high precision and reproducibility.
- The assay shows strong intermethod correlation, making it a reliable alternative to manual CA 15-3 tests.
- Its demonstrated characteristics support the use of the Bayer Immuno 1 assay for longitudinal monitoring of breast cancer patients.
