Abstract:

Objective To compare the performance of 4 commercial kits for the detection of severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） nucleic acid. Methods Totally,318 pharyngeal swab samples were collected. After nucleic acid extraction,these samples were detected by the 4 commercial kits. Results Kappa values were 0.741（Kit A vs Kit B）,0.653（Kit A vs Kit C）,0.510（Kit A vs Kit D）,0.669（Kit B vs Kit C）,0.633（Kit B vs Kit D） and 0.565（Kit C vs Kit D）（P<0.01）. The positive rates of Kit A,Kit B,Kit C and Kit D were 39.94%,30.50%,31.45% and 18.55%,respectively. There was statistical significance（P<0.05） except for that between Kit B and Kit C（P>0.05）. The sensitivity and specificity were 98.2% and 90.4% for Kit A,87.1% and 99.0% for Kit B,82.6% and 95.2% for Kit C,54.1% and 100.0% for Kit D,respectively,and the accuracy of Kit D was lower than those of the other kits（P<0.05）. Conclusions The performance of Kit A is consistent with that of Kit B,and Kit A has good sensitivity and accuracy for the detection of SARS-CoV-2 nucleic acid. Kit D is not appropriate for screening corona virus disease 2019（COVID-19） due to its low sensitivity.

Key words: Severe acute respiratory syndrome coronavirus 2, Nucleic acid detection, Pharyngeal swab, Comparison, Kit