A multiple-center clinical evaluation of a new real-time reverse transcriptase PCR diagnostic kit for SARS-CoV-2

Guo, Jing-Jing; Yu, Yan-Hua; Ma, Xue-Ying; Liu, Ya-Nan; Fang, Qian; Qu, Pei; Guo, Jie; Lou, Jin-Li; Wang, Ya-Jie

Aim: The outbreak of severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has had serious repercussions worldwide. This study was aimed to evaluate the accuracy of a new kit for detection of SARS-CoV-2 compared with similar detection kit. Materials & methods: A total of 500 subjects were included and tested with both the new test and control kits. Clinical diagnosis results were taken as the reference standard. Results: Compared with clinical diagnosis, the sensitivity of the test kit was 82.64%, specificity was 98.45% and total coincidence rate was 90.80%. The total coincidence rate, sensitivity and specificity between control kit and clinical diagnosis were 89.20%, 78.10% and 99.61%, respectively. Conclusions: The new kit was comparable to the similar detection kit for detection of SARS-CoV-2 in sensitivity, specificity and total coincidence rate.