[Clinical evaluation of serum prostatic acid phosphatase assay based on the immunoenzymatic method (TZR-516)].

The usefulness of a newly developed prostatic acid phosphatase assay based on the immunoenzymatic method (PAP-IEA) was studied. Serum samples were obtained from 22 untreated prostatic carcinoma patients, 34 benign prostatic hyperplasia patients, 32 prostatic disease-free patients and 27 normal volunteers. Mean +/- S.D. of PAP-IEA in prostatic disease-free group and normal volunteer group was 0.46 +/- 0.27 ng/ml. So, the upper limit of PAP-IEA for clinical normal range was set to 1 ng/ml (= Mean + 2S.D.). Thus, the false positive rate of benign prostatic hyperplasia was estimated at 9% and false negative rate of untreated prostatic carcinoma at 27%. Meanwhile, PAP-IEA values measured in this study were correlated well to PAP-RIA values measured in the same samples (r = 0.994).