Real-time reverse transcription polymerase chain reaction (RT-qPCR) is the most sensitive and specific assay and, therefore, is the “gold standard” diagnostic method for the diagnosis of SARS-CoV-2 infection. The aim of this study was to compare and analyze the detection performance of three different commercially available SARS-CoV-2 nucleic acid detection kits: Sansure Biotech, GeneFinder TM , and TaqPath TM on 354 randomly selected samples from hospitalized COVID-19 patients. All PCR reactions were performed using the same RNA isolates and one real-time PCR machine. The final result of the three evaluated kits was not statistically different ( p = 0.107), and also had a strong positive association and high Cohen’s κ coefficient. In contrast, the average Ct values that refer to the ORF1ab and N gene amplification were significantly different ( p < 0.001 and p < 0.001, respectively), with the lowest obtained by the TaqPath TM for the ORF1ab and by the Sansure Biotech for the N gene. The results show a high similarity in the analytical sensitivities for SARS-CoV-2 detection, which indicates that the diagnostic accuracy of the three assays is comparable. However, the SanSure Biotech kit showed a bit better diagnostic performance. Our findings suggest that the imperative for improvement should address the determination of cut-off Ct values and rapid modification of the primer sets along with the appearance of new variants.
【저자키워드】 COVID-19, SARS-CoV-2, Real-time PCR, molecular testing, PCR kits, diagnostic efficacy, 【초록키워드】 SARS-COV-2 infection, Infection, diagnostic, variants, RNA, polymerase chain reaction, amplification, nucleic acid, SARS-CoV-2 detection, RT-qPCR, Diagnostic accuracy, Accuracy, gold, reverse transcription, N gene, Diagnostic method, analytical sensitivity, association, TaqPath, ORF1ab, similarity, Ct values, gene amplification, Chain Reaction, Real-Time Reverse Transcription Polymerase Chain Reaction, hospitalized COVID-19 patients, appearance, average, SARS-CoV-2 nucleic acid, Final, primer sets, cut-off, positive, Modification, ORF1, PCR reaction, isolate, polymerase chain, lowest, performed, significantly, primer set, evaluated, indicate, imperative, comparable, statistically, diagnosis of SARS-CoV-2, randomly selected sample, 【제목키워드】 detection, PCR,