The novel coronavirus (2019-nCoV) nucleic acid isothermal amplification rapid detection kit, jointly developed by the National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention and Jiangsu Qi Tian Gene Biotechnology Co., Ltd., has completed clinical evaluation at the First Affiliated Hospital of Zhejiang University School of Medicine (92 clinical specimens), Zhejiang Provincial Center for Disease Control and Prevention (104 clinical specimens), and Jiangsu Provincial Center for Disease Control and Prevention (100 specimens). After nucleic acid extraction, the kit was used to detect novel coronavirus nucleic acid, with results available in 8-15 minutes. Compared with commercially available quantitative PCR kits approved by the drug regulatory authority, the kit showed 100% positive agreement rate, 100% negative agreement rate, and 100% overall agreement rate, demonstrating equivalence. This kit is recommended by the above evaluation units for the qualitative detection of 2019-nCoV in clinical settings, to differentiate patients with suspected 2019-nCoV infection. The kit is suitable for use in prefecture-level laboratories. Currently, the kit is undergoing application for approval number from the drug regulatory authority.

　　In April 2020, the research team from the CDC's Viral Disease Prevention and Control Institute published a related article in Clinical Microbiology and Infection, titled: "A multiple center clinical evaluation of an ultra-fast single-tube assay for SARS-CoV-2 RNA".

　　 Abstract

　　 Objectives: To evaluate the performance of an ultra-fast single-tube nucleic acid isothermal amplification detection assay for SARS-CoV-2 RNA using clinical samples from 44 multiple centers.

　　 Methods: A reverse transcription recombinase-aided amplification (RT-RAA) assay for SARS-CoV-2 was conducted within 15 minutes at 39°C with portable instruments after addition of extracted RNA. The clinical performance of RT-RAA assay was evaluated using 947 clinical samples from five institutions in four regions of China, and the approved commercial real-time fluorescent RT-PCR (qRT-PCR) kits were used for parallel detection. The sensitivity and specificity of RT-RAA were compared and analyzed.

　　 Results: The RT-RAA test results of 926 samples were consistent with those of qRT-PCR (330 were positive, 596 were negative) and 21 were inconsistent. The sensitivity and specificity of RT-RAA was 97.63% [330/338, 95% confidence interval (CI): 95.21 to 98.90] and 97.87% (596/609, 95% CI: 96.28 to 98.81), respectively. The positive predictive value (PPV) and negative predictive value (NPV) were 96.21% (330/343, 95% CI: 93.45 to 97.88), and 98.68% (596/604, 95% CI: 97.30 to 99.38), respectively. The total coincidence rate was 97.78% (926/947, 95% CI: 96.80 to 98.70) and the Kappa was 0.952 (P <0.05).

　　 Conclusion: With comparable sensitivity and specificity to the commercial qRT-PCR kits, RT-RAA assay for SARS-CoV-2 exhibited distinctive advantages of simplicity and rapidity in terms of operation and turn-around time.