Comparison of the diagnostic efficacy between two PCR test kits for SARS-CoV-2 nucleic acid detection.

ABSTRACT

BACKGROUND: To compare the diagnostic efficacy between two different real-time reverse transcription polymerase chain reaction (RT-PCR) test kits for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid detection and provide references for laboratories. METHODS: Throat swab samples from 18 hospitalized patients were clinically diagnosed with coronavirus disease 2019 (COVID-19) and 100 hospitalized patients without COVID-19 were collected. SARS-CoV-2 nucleic acid was detected in throat swab samples with RT-PCR test kits from Sansure Biotech Inc (Hunan, China) and Shanghai BioGerm Medical Biotechnology Co., Ltd.(Shanghai, China). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa value were analyzed, and three parallel tests were performed with three weakly positive samples. RESULTS: The sensitivity, specificity, PPV, NPV, and kappa value of the Sansure PCR kit were 0.833, 1.000, 1.000, 0.971, and 0.894, respectively, and the sensitivity, specificity, PPV, NPV, and kappa value of the BioGerm PCR kit were 0.944, 1.000, 1.000, 0.990, and 0.966, respectively. For the three parallel tests, the coefficient of variation value of the BioGerm PCR kit in all three samples was the smallest for both the ORF1ab and N gene. CONCLUSION: The detection efficacy of the BioGerm PCR kit for SARS-CoV-2 nucleic acid detection was relatively higher than that of the Sansure PCR kit.