Comparability of the Tandem-R and IMx assays for the measurement of serum prostate-specific antigen.

OBJECTIVES To assess the comparability of the Tandem-R and IMx serum prostate-specific antigen (PSA) assays across levels of the ratio of free-to-total serum PSA found in a community-based population of healthy men. METHODS Banked serum samples from the baseline component of the Olmsted County Study of Urinary Symptoms and Health Status Among Men were thawed and analyzed using the Tandem-R and IMx PSA assays. Serum levels also were determined for the free, noncomplexed form of PSA, PSA complexed to alpha-1 antichymotrypsin, and total PSA with a research-based immunofluorometric assay. RESULTS The results of the Tandem-R and IMx assays were strongly correlated at all levels of the ratio of free-to-total serum PSA. The Spearman correlation coefficients ranged from 0.87 to 0.98 (all p < 0.001). The relationship between the Tandem-R and IMx assays, however, differed at low levels of free-to-total serum PSA compared with high levels. In the lowest 10th percentile of the ratio of free-to-total serum PSA (0.04 to 0.18), the IMx assay read lower than the Tandem-R (slope +/- standard error = 0.92 +/- 0.04, intercept +/- standard error = 0.21 +/- 0.14); whereas in the upper 10th percentile of free-to-total ratio (0.46 to 0.65) the IMx assay yielded values higher than the Tandem-R assay (slope = 1.21 +/- 0.07, intercept = 0.14 +/- 0.05). In the middle 90%, the slope did not statistically differ from 1.0. CONCLUSIONS For the majority of men, results of the Tandem-R and IMx PSA assays were virtually identical. The small differences found would not be of clinical significance for most men but should be considered when comparing results of different assays in sequential determinations for a specific man.