Clinical Performance Evaluation of the PSA Rapid Test Cassette (TPS-402): Comparative Analysis With ACON Total PSA ELISA Test Kit

Abstract

This study evaluates the diagnostic accuracy of the PSA Rapid Test Cassette (TPS-402) using a clinical dataset: a 2021 comparison with ACON Total PSA ELISA Test Kit (n = 561), including 207 PSA-positive specimens and 354 PSA-negative specimens confirmed by the ELISA kit and clinical symptoms. The cassette correctly identified 205 of 207 ELISA-positive specimens and 351 of 354 ELISA-negative specimens, achieving a relative sensitivity of 99.0%, a relative specificity of 99.2%, and an overall accuracy of 99.1%. These findings confirm that TPS-402 delivers laboratory-comparable performance while retaining the speed and simplicity required for point-of-care testing.