Multicenter evaluation of the performance and clinical utility in longitudinal monitoring of the Bayer Immuno 1 complexed PSA assay.
We conducted a multicenter evaluation of the analytical and clinical performance of the automated Bayer Immuno 1 complexed PSA (cPSA) assay, and compared assay performance to the Bayer Immuno 1 PSA assay. We sought to determine whether measurements of cPSA could be of clinical utility in the management of patients with prostate cancer. Results of the 10-day imprecision across three evaluation sites produced total CV < 2.50% and an analytical sensitivity of 0.02 microgram/L. There was an increased trend in clinical sensitivity for prostate cancer with increasing stage of disease (71-86%). Clinical specificity for patients with benign urogenital disease was 74.8%, and for other nonprostate diseases ranged from 91.1-100%. Retrospective serial monitoring of 155 patients with prostate cancer demonstrated concordance of cPSA measurements to clinical status for 97% of the patients analyzed. Results from the clinical studies using the Bayer Immuno 1 cPSA assay were comparable to results obtained with the Bayer Immuno 1 PSA assay. The Bayer Immuno 1 cPSA assay demonstrates analytical performance and clinical effectiveness in the management of prostate cancer patients during the course of disease and therapy.
Allard
W J
WJ
Bayer Corporation, Tarrytown, New York, USA. jeffrey.allard.b@bayer.com
Cheli
C D
CD
Morris
D L
DL
Goldblatt
J
J
Pierre
Y
Y
Kish
L
L
Chen
Y
Y
Dai
J
J
Vessella
R L
RL
Chan
D W
DW
Schwartz
M K
MK
Zhou
Z
Z
Yeung
K K
KK
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000175:diagnosis*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D011933:Reagent Kits, Diagnostic; D017430:Prostate-Specific Antigen