Evaluation of an automated chemiluminescent immunoassay for complexed PSA on the Bayer ACS:180™ system

Prostate-specific antigen (PSA), the most important tumor marker for the detection of prostate cancer, exists in serum in a free, uncomplexed form (free PSA [fPSA]), and as bound to protease inhibitors (mainly alpha1-antichymotrypsin [ACT]). The measurement of complexed PSA (cPSA) concentration in serum has been shown to have better sensitivity and specificity than serum total PSA concentration. A new chemiluminescent immunoassay for cPSA for use on the Bayer ACS:180(TM) fully automated system (Bayer Corp., Tarrytown, NY) has been developed and evaluated. The precision of the new assay was <3.9% (within-run coefficient of variation [CV]) and <5.0% (total CV). The analytical sensitivity (95% upper limit of noise at zero calibrator) was <0.03 ng/mL. A comparison of the ACS:180(TM) cPSA results with the cPSA concentrations calculated from the ACCESS (Beckman-Coulter) PSA and fPSA assays yielded the following regression equation: ACS:180(TM) cPSA = 0.93* (calculated ACCESS cPSA) +0.43, R = 0.993, n = 95. The mean dilution and spike recovery for five samples were both 98%. No interference was observed from hemoglobin, triglyceride, or bilirubin (NCCLS protocol). These results indicate that the ACS:180(TM) cPSA assay is precise, and compares well with the calculated cPSA from ACCESS total and free-PSA results.