The clinical assessment of rapid nucleic acid detection kit for 2019-nCoV developed by Jiangsu Qitian Gene Biotechnology Co., Ltd. and National Institute For Viral Disease Control and Prevention of Chinese Center for Disease Control and Prevention has been completed by The First Affiliated Hospital, Zhejiang University (92 clinical specimens), Zhejiang Provincial Center for Disease Control and Prevention (104 clinical specimens), Jiangsu Provincial Center for Disease Control and Prevention (100 clinical specimens). Using this kit, the detection can be done in 8 to 15 minutes after nucleic acid extraction. This kit showed a 100% coincidence rate (100% positive coincidence rate, 100% negative coincidence rate) compared to commercial quantitative PCR kits approved by National Medical Products Administration. The performance of this rapid nucleic acid detection kit is comparative to that of quantitative PCR kits. This kit has been recommended for clinical qualitative detection of 2019-nCoV to identify patients infected by the new coronavirus. This kit is suitable for provincial and city-level laboratories and we are now applying for approval number from National Medical Products Administration.

The R&D team of the Center for Disease Control and Prevention of the CDC in April 2020 published a related article in "Clinical Microbiology and Infection": The title is: "A multiple center clinical evaluation of an ultra-fast single-tube assay for SARS- CoV-2 RNA. The abstract is as follows:

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 15minutesat39ı 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.