Evaluation of an automated CRISPR-based diagnostic tool for rapid detection of COVID-19
Jun Xu,
Yuanyuan Ma,
Zhigang Song,
Wei Sun,
Yi Liu,
Chang Shu,
Hua Hua,
Ming Yang,
Qi Liang
Affiliations
Jun Xu
Department for Viral Disease Control and Prevention, Heilongjiang Provincial Center for Disease Control and Prevention, Harbin 150030, China
Yuanyuan Ma
Department of Drug Clinical Trial, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China
Zhigang Song
Pathogen Detection and Biosafety Department, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China; Corresponding author.
Wei Sun
Department for Viral Disease Control and Prevention, Heilongjiang Provincial Center for Disease Control and Prevention, Harbin 150030, China; Corresponding author.
Yi Liu
Pathogen Detection and Biosafety Department, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China
Chang Shu
Department for Viral Disease Control and Prevention, Heilongjiang Provincial Center for Disease Control and Prevention, Harbin 150030, China
Hua Hua
Department for Viral Disease Control and Prevention, Heilongjiang Provincial Center for Disease Control and Prevention, Harbin 150030, China
Ming Yang
Department for Viral Disease Control and Prevention, Heilongjiang Provincial Center for Disease Control and Prevention, Harbin 150030, China
Qi Liang
Department for Viral Disease Control and Prevention, Heilongjiang Provincial Center for Disease Control and Prevention, Harbin 150030, China
The performance of an automated commercial CRISPR/Cas based technology was evaluated and compared with routine RT-PCR testing to diagnose COVID-19. Suspected and discharged COVID-19 cases were included and tested with CRISPR-based SARS-CoV-2 test and RT-PCR assay using throat swab and sputum specimens. The diagnostic yield was calculated and compared using the McNemar test. A total of 437 patients were included for analysis, including COVID-19 (n = 171), discharged cases (n = 155), and others (n = 111). For the diagnosis of COVID-19, the CRISPR-SARS-CoV-2 test had a sensitivity and specificity of 98.2% (168/171) and 100.0% (266/266), respectively; the RT-PCR test had a sensitivity and specificity of 100.0% (171/171) and 100.0% (266/266), respectively. No significant difference was found in the sensitivity of CRISPR-SARS-CoV-2 and RT-PCR. In conclusion, the CRISPR-SARS-CoV-2 test had a comparable performance with RT-PCR and showed several advantages, such as short assay time, low cost, and no requirement for expensive equipment.
