Multicenter evaluation of the Bayer Immuno I CA 15-3 assay.
We conducted a multicenter evaluation of the analytical and clinical features of the automated Bayer Immuno 1 CA 15-3 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 < or = 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 27.29 and Centocor CA 15-3 RIAs (r > or = 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.
Cheli
C D
CD
Bayer Corporation, Business Group Diagnostics, Tarrytown, NY 10591, USA. carol.cheli@diabetesdisc.com
Morris
D L
DL
Kish
L
L
Goldblatt
J
J
Neaman
I
I
Allard
W J
WJ
Yeung
K K
KK
Wu
A H
AH
Moore
R
R
Chan
D W
DW
Fritsche
H A
HA
Schwartz
M K
MK
Very
D L
DL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood; D001943:Breast Neoplasms / Q000097:blood; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008175:Lung Neoplasms / Q000097:blood; D008875:Middle Aged; D018396:Mucin-1 / Q000097:blood*; D010051:Ovarian Neoplasms / Q000097:blood; D011863:Radioimmunoassay; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D014408:Biomarkers, Tumor; D018396:Mucin-1