Sensitive and Easy-Read CRISPR Strip for COVID-19 Rapid Point-of-Care Testing,The CRISPR Journal

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Sensitive and Easy-Read CRISPR Strip for COVID-19 Rapid Point-of-Care Testing
The CRISPR Journal ( IF 3.7 ) Pub Date : 2021-06-16 , DOI: 10.1089/crispr.2020.0138
Hao Li ₁ , Xue Dong ₁ , Yanhe Wang ₁ , Lan Yang ₁ , Kun Cai ₂ , Xiaolu Zhang ₁ , Zhihua Kou ₁ , Lei He ₁ , Shihui Sun ₁ , Tianyao Li ₁ , You Nie ₁ , Xiaofeng Li ₁ , Yansong Sun ₁

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Rapid and clinically sensitive detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) play an important role in the contact tracing and containment of the COVID-19 pandemic. A recently developed field-deployable clustered regularly interspaced short palindromic repeats (CRISPR) detection assay with lateral flow strips shows promise for point-of-care detection of SARS-CoV-2. However, the limit of detection of paper strip-based assays (10–100 copies/μL) is much lower than that of fluorescence-based detection methods. In this study, we developed an easy-readout and sensitive enhanced (ERASE) strip to visualize the results of CRISPR detection and improve the sensitivity to 1 copy/μL with an unambiguous easy-read result. Using 649 clinical samples from blind specimens collected from patients in China, we validated our ERASE assay for SARS-CoV-2 RNA detection with 90.67% positive predictive agreement and 99.21% negative predictive agreement. In conclusion, our study provided a customized CRISPR strip for use in a simple, rapid, ultrasensitive, and highly specific assay for SARS-CoV-2 detection. (Clinical Trial Registration number: 2020-008-01; [2020]IEC(ZD01); PJ-NBEY-2020-009-01; 2020#34).

更新日期：2021-06-21

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