Comparison of three commercial PSA assays: Results of restandardization of the Ciba Corning method

摘要: BACKGROUND Consistency in prostate-specific antigen (PSA) quantitation by different PSA test manufacturers would minimize potential clinical confusion. The Ciba Corning ACS™ PSA2 calibration has been adjusted for alignment with a proposed international standard and concordance the Hybritech Tandem R assay. Herein we evaluate effectiveness of this recalibrated comparing it IMx (Abbott Laboratories) (Hybritech) assays. METHODS Archival serum was used that had stored at −70°C from men who underwent ultrasound-guided prostate needle biopsy. Assays were run according to each manufacturer's specifications singlicate on single thaw. RESULTS The study included sera 191 patients; 44 patients carcinoma. There 151 (Tandem R) range 0–10.0 ng/ml, 28 whom cancer. correlation coefficients versus ACS, IMx, ACS 0.958, 0.955, 0.979 benign 0.960, 0.954, 0.985 those cancer, respectively. corresponding slopes 1.029, 0.855, 0.824 without 1.044, 0.830, 0.790, respectively, malignancy. CONCLUSIONS These data demonstrate substantial equivalence restandardized assay method. Significant bias exists between these methods lower results being identified latter. These findings have significant implication, particularly screening when an are compared other assays. Prostate 30:269–273, 1997. © 1997 Wiley-Liss, Inc.1