Performance characteristics of a RT-PCR kit for in vitro diagnostics of EGFR gene mutations (test-EFRG)

The detection of various mutations using RT-PCR techniques is currently relevant. The aim of the study was to assess performance characteristics of a kit developed for the detection of mutations in the EGFR gene using RT-PCR method (EGFR-test) for its further implementation into routine laboratory practice. The study was conducted in the Republican Clinical Oncology Dispensary. We evaluated the kit for in vitro diagnostics of the EGFR gene mutations through RT-PCR produced in two variants: 1) «Test-EGFR-12» for 12 tests, 2) «Test-EGFR-24» for 24 tests (manufactured by the LLC ‘TestGen’). We tested 50 DNA samples isolated form blood specimens of patients diagnosed with stage 3-4 metastatic non-small cell lung cancer (NSCLC). The samples were obtained from the archive of residual plasma aliquots used for routine laboratory testing. The mutation of the EGFR-gene was detected in 28 specimens, whereas 22 samples were negative for EGFR-mutations. We analyzed 50 plasma specimens and revealed one false negative result. The assessment of the test performance characteristics confirmed its quality, effectiveness, and safety. Statistical analysis showed that diagnostic sensitivity of the assay was 90.1%, specificity reached 95.9%, and the rate of false negative results was 9.9%. Reproducibility of the test was 100%. The evaluation of diagnostic characteristics of the assay demonstrated its high robustness.