关键词: 严重急性呼吸综合征冠状病毒2, 新型冠状病毒肺炎, 核酸检测试剂盒, 假阴性

Abstract:

Objective To evaluate the consistency of 4 severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） nucleic acid detection kits in the diagnosis of corona virus disease 2019（COVID-19）. Methods A total of 204 inpatients diagnosed with COVID-19 in Wuhan Asia General Hospital from February 18,2020 to February 24,2020 were enrolled. The residual samples were used to evaluate the consistency of 4 SARS-CoV-2 nucleic acid detection kits approved for emergency registration. Based on the clinical diagnosis of COVID-19,the positive detection of any of the 4 kits was used as a reference. The sensitivities and specificities of the 4 kits for the detections of ORF1ab gene and N gene were compared. The consistency was analyzed statistically by Kappa consistency analysis and Chi-square test. Results The overall detection rates of the 4 kits were 72.4%,78.0%,59.3% and 72.4%,respectively（P=0.011）. The detection rates of A,B,C and D kits for ORF1ab gene were 47.7%,31.8%,68.2% and 83.2%,respectively（P<0.000 1）. The detection rates of A,B and C kits for N gene were 79.0%,90.5% and 16.2%,respectively（P<0.000 1）. Conclusions There is a certain proportion of false negativity in SARS-CoV-2 nucleic acid detection kits,and there is statistical significance in the performance of nucleic acid detection kits with different brands. The detection rate may be improved using nucleic acid detection kits with different brands combinedly.

Key words: Severe acute respiratory syndrome coronavirus 2, Corona virus disease 2019, Nucleic acid detection kit, False negativity