A multiple-center Clinical Evaluation of a New real-time Reverse Transcriptase PCR Diagnostic Kit for SARS-CoV-2

Abstract

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.

Keywords:

• detection
• evaluation
• real-time PCR Kit
• SARS-CoV-2

Author contributions

Conception and design: Y-J Wang; data collection: J-J Guo, J Guo; data analysis and interpretation: Y-J Wang, J-J Guo; providing materials and samples: J Guo, Y-H Yu, X-Y Ma, Y-N Liu, P Qu, Q Fang; drafting article: J-J Guo, Y-J Wang; administrative support: Y-J Wang. All the authors have read and approved the final manuscript.

Financial & competing interests disclosure

This work was supported by Beijing Municipal Science & Technology Commission [nos. Z201100005420022 and Z201100005420012] and Beijing Medical Management Center [no. COVID-19-BHA05]. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

This study was conducted in accordance with Declaration of Helsinki and Good Clinical Practice Guidelines, and approved by ethics committee institutional review board of each participating center (number: 2020003-01 and 2020029). All the specimens were remaining specimens after clinical testing, and the sensitive information such as the name of subjects was not presented in our study. Therefore, the informed consent of patients was exempted with the approval of ethics committee.

Acknowledgment

The authors thank Beijing Youan Hospital and Beijing Ditan Hospital for providing data support.