Measurement of serum PA values by a newly developed enzyme immunoassay

Abstract

Serum prostate-specific antigen (PA) values detected by a newly developed enzyme immunoassay (EIA, MARKIT-M PA) as a successor of MARKIT-F PA, which has been a leading kit in Japan, were evaluated for its role in the diagnosis of cancer of the prostate and follow-up of the patients afflicted with the disease. The system is one-step sandwich type EIA using horseradish peroxidase as a tracer and has 0.50-100 ng/ml of detectable range with small amount of sample volume (25 microliters) and reliable quality control data. Furthermore, serum PA values detected by the assay were almost equivocal to those detected by MARKIT-F PA. Serum PA values in prostate cancer patients (n = 122) were statistically higher than those in normal males (n = 90), urological malignancies other than prostate cancer (n = 48) or benign prostatic hypertrophy (BPH, n = 73). Even in the patients with stage A and B prostate cancer, serum PA values were observed to be statistically higher than those in BPH cases. If 3.6 ng/ml was used, which is normal value in MARKIT-F PA, as a cut-off value and BPH cases as a control, the sensitivity, specificity and efficacy for diagnosis of prostate cancer were 77.9, 91.8 and 83.1%, respectively, which showed the best results during the range examined. Serially determined serum PA values in following up the patients with prostate cancer were confirmed to be highly effective to evaluate treatment responses. These results suggest that MARKIT-M PA is thought to be one of the best tool for determination of serum PA values.