Multicenter evaluation of the Bayer Immuno 1™ CA 15-3™ assay Journal Article
| Authors: | Cheli, C. D.; Morris, D. L.; Kish, L.; Goldblatt, J.; Neaman, I.; Allard, W. J.; Yeung, K. K.; Wu, A. H. B.; Moore, R.; Chan, D. W.; Fritsche, H. A.; Schwartz, M. K.; Very, D. L. Jr |
| Article Title: | Multicenter evaluation of the Bayer Immuno 1™ CA 15-3™ assay |
| 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. |
| Keywords: | adolescent; adult; controlled study; aged; aged, 80 and over; middle aged; major clinical study; clinical trial; diagnostic accuracy; sensitivity and specificity; ovarian neoplasms; reproducibility; reproducibility of results; breast cancer; lung neoplasms; tumor markers, biological; calibration; breast neoplasms; automation; multicenter study; reference values; intermethod comparison; immunoassay; performance; radioimmunoassay; ca-15-3 antigen; ca 15-3 antigen; humans; human; female; article |
| Journal Title: | Clinical Chemistry |
| Volume: | 44 |
| Issue: | 4 |
| ISSN: | 0009-9147 |
| Publisher: | American Association for Clinical Chemistry |
| Date Published: | 1998-04-01 |
| Start Page: | 765 |
| End Page: | 772 |
| Language: | English |
| PUBMED: | 9554487 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 12 December 2016 -- Source: Scopus |
