Performance evaluation of a new chemiluminescent assay for prostate specific antigen

摘要

Prostate specific antigen (PSA) is a glycoprotein found in the epithelial cells of the prostatic duct and acini. PSA is elevated in all four stages of prostate cancer as well as in benign prostatic hypertrophy. We evaluated a new chemiluminescent assay for PSA by comparing this assay with the microparticle enzyme immunoassay for PSA (MEIA) on the AxSYM analyzer (Abbott Laboratories, Abbott Park, IL) and a Hybritech Tandem R assay for PSA. The new chemiluminescent assay is recently available from Bayer Diagnostics (Tarrytown, NY) and can be run using the ACS: 180 Plus analyzer. Precision of the new chemiluminescent assay was evaluated using commercially available controls (Bayer Diagnostics). The within‐run and total CVs were 6.4 and 8.7% for the low control (mean: 0.43 μg/L), 1.6 and 5.2% for the next level control (mean:1.94 mg/L), 4.3 and 4.9% for the medium control (mean: 2.10 mg/L), 1.2 and 3.9% for the high control 1 (mean: 11.52 mg/L), and finally 3.2 and 6.9% for the high control 2 (mean: 21.52 mg/L). The spike recovery varied from 94.2 to 109.6% for five different specimens we studied. We also observed excellent dilution recoveries. For example, in the specimen supplemented with 3.02 mg/L of PSA, the dilution recoveries were 102.1, 104.7, and 103.7% for 1:2, 1:4, and 1:8 dilutions, respectively. We analyzed 113 serum specimens from patients with various concentrations of PSA (range 0.5 mg/L–2040 mg/L) using the new chemiluminescent assay and compared our results with the MEIA and Hybridtech (Tandem‐R PSA) assays. Using x axis as the PSA concentrations obtained by the Tandem‐R assay and the y axis as the PSA values obtained by the new chemiluminescent assay, we observed the following regression equations: y = 1.04 × –0.19 (r = 0.99, n = 112). One specimen with PSA concentrations of 2040 μg/L by the MEIA and 2156 μg/L by the chemiluminescent assay was not used for regression analysis. Similarly using x axis as the PSA concentrations obtained by the MEIA assay and axis as the PSA concentrations obtained by the chemiluminescent assay, we observed the following regression equation: y = 0.88 + 0.02 (r = 0.99, n = 112). We conclude that the new chemiluminescent assay has excellent precision and the results compared well with the existing assays. J. Clin. Lab. Anal. 14:164–168, 2000. © 2000 Wiley‐Liss, Inc.