Multicentre evaluation of a new fully automated enzyme immunoassay for total prostate-specific antigen

The evaluation is reported of a newly developed automated assay for measuring total prostate-specific antigen: Enzymun-Test PSA. Starting with a small field study, the study was extended to 74 laboratories in different countries. The median values for the intra-assay imprecision ranged from 5.0% (0.0-2.0 micrograms/l) to 2.5% (> 10.0 micrograms/l). For the inter-assay imprecision the results for the same ranges were 23.2 and 3.8%, respectively. The lower limit of detection, biological and functional sensitivity were 0.03, 0.1 and 0.25 micrograms/l, respectively. The linearity and dilution experiments showed acceptable data. The determined reference ranges (95% confidence intervals) were: men < 40 years: 0.1-1.3 micrograms/l, men 40-50 years: 0.2-2.0 micrograms/l, men 50-60 years: 0.2-3.0 and men > 60 years: 0.2-4.5 micrograms/l. Comparison of Enzymun-Test PSA with most present-day commercially available assays generally revealed very good correlations.

the new Boehringer Mannheim Enzymun-Test PSA is compatible with the state-of-the-art for the measurement of total prostate-specific antigen.