Multiple-centre clinical evaluation of an ultrafast single-tube assay for SARS-CoV-2 RNA. (August 2020)

• Record Type: Journal Article
• Authors: Wang, J.; Cai, K.; He, X.; Shen, X.; Wang, J.; Liu, J.; Xu, J.; Qiu, F.; Lei, W.; Cui, L.; Ge, Y.; Wu, T.; Zhang, Y.; Yan, H.; Chen, Y.; Yu, J.; Ma, X.; Shi, H.; Zhang, R.; Li, X.; Gao, Y.; Niu, P.; Tan, W.; Wu, G.; Jiang, Y.; Xu, W.; Ma, X.
• Is Part Of: Clinical microbiology and infection. Volume 26:Number 8(2020)
• Page Start: 1076
• Page End: 1081
• Publication Date: 2020-08
• Subjects: COVID-19 -- Detection -- Multicentre evaluation -- RT-RAA -- SARS-CoV-2; Medical microbiology -- Periodicals; Diagnostic microbiology -- Periodicals; Communicable diseases -- Periodicals; Infection -- Periodicals; 616.01
• DOI: 10.1016/j.cmi.2020.05.007
• Languages: English
• ISSNs: 1198-743X

Abstract

Abstract: Objective: To evaluate the performance of an ultrafast single-tube nucleic acid isothermal amplification detection assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA using clinical samples from multiple centres. 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; approved commercial fluorescence quantitative real-time PCR (qRT-PCR) kits were used for parallel detection. The sensitivity and specificity of RT-RAA were compared and analysed. Results: The RT-RAA test results of 926 samples were consistent with those of qRT-PCR (330 were positive, 596 negative); 21 results 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 and negative predictive values 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). Conclusions: With comparable sensitivity and specificity to the commercial qRT-PCR kits, RT-RAA assay for SARS-CoV-2 exhibited the distinctive advantages of simplicity and rapidity in terms of operation and turnaround time.