Performance characteristics of the prosta-test assay for in vitro measurement of the PCA3 mRNA levels using a two-stage RT-QPCR in patients with prostate cancer

The aim of the study was to assess performance characteristics of the Prosta-Test diagnostic kit and to implement it into clinical and laboratory practice. The kit is designed for the diagnosis of prostate cancer by measuring PCA3 mRNA levels using a two-stage real-time reverse transcription-polymerase chain reaction (RT-qPCR). The study was conducted in the Republican Clinical Oncology Dispensary. We evaluated the kit for in vitro measurement of the PCA3 mRNA level using a two-stage RT-qPCR (Prosta-Test) produced in two variants: 1) ‘Prosta-Test-12’ for 12 tests and 2) ‘Prosta-Test-24’ for 24 tests (manufactured by the LLC ‘TestGen’). We tested 50 urine cellular sediments obtained after centrifugation. The urine specimens were collected after prostate massage from male patients over 40 years of age with indications for prostate biopsy. We have already assessed diagnostic accuracy of the assay on 200 urine samples (cellular sediments) and found that its performance characteristics were similar to those observed in the current study...