Development of an automatic integrated gene detection system for novel severe acute respiratory syndrome-related coronavirus (SARS-CoV2). Issue 1 (1st January 2020)

• Record Type: Journal Article
• Authors: Li, Yuchang; Li, Jing; Zhang, Ying; Dai, Lizhong; Li, Lin; Liu, Juan; Zhang, Sen; Wu, Xiaoyan; Hu, Yi; Qin, Chengfeng; Jiang, Tao; Kang, Xiaoping
• Is Part Of: Emerging microbes & infections. Volume 9:Issue 1(2020)
• Page Start: 1489
• Page End: 1496
• Publication Date: 2020-01-01
• Subjects: SARS-CoV2 -- automatic integrated gene detection system -- qRT-PCR -- COVID-19 -- rapid detection; Medical microbiology -- Periodicals; Communicable diseases -- Periodicals; Infection -- Periodicals; 616.9041
• DOI: 10.1080/22221751.2020.1782774
• Languages: English
• ISSNs: 2222-1751

Abstract

ABSTRACT: In December 2019, Wuhan, China suffered a serious outbreak of a novel coronavirus infectious disease (COVID) caused by novel severe acute respiratory syndrome-related coronavirus (SARS-CoV 2). To quickly identify the pathogen, we designed and screened primer sets, and established a sensitive and specific qRT-PCR assay for SARS-CoV 2; the lower limit of detection (LOD) was 15 (95% CI: 9.8–21) copies per reaction. We combined this qRT-PCR assay with an automatic integration system for nucleic acid extraction and amplification, thereby establishing an automatic integrated gene detection system (AIGS) for SARS-CoV 2. Cross reactive analysis performed in 20 other respiratory viruses and 37 nasopharyngeal swabs confirmed a 100% specificity of the assay. Using two fold diluted SARS-CoV 2 culture, the LOD of AIGS was confirmed to be 365 copies/ml (95% CI: 350–375), which was Comparable to that of conventional qRT-PCR (740 copies/ml, 95% CI: 690–750). Clinical performances of AIGS assay were assessed in 266 suspected COVID-19 clinical respiratory tract samples tested in parallel with a commercial kit. The clinical sensitivity of the AIGS test was 97.62% (95% CI: 0.9320–0.9951) based on the commercial kit test result, and concordance analysis showed a high agreement in SARS-CoV-2 detection between the two assays, Pearson R was 0.9623 (95% CI: 0.9523–0.9703). The results indicated that this AIGS could be used for rapid detection of SARS-CoV 2. With the advantage of simple operation and less time consuming, AIGS could be suitable for SARS-CoV2 detection in primary medical institutions, thus would do a great help to improve detection efficiency and control the spread of COVID-19.