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. 2020 Dec;4(12):1150-1158.
doi: 10.1038/s41551-020-00655-z. Epub 2020 Dec 3.

Rapid lateral flow immunoassay for the fluorescence detection of SARS-CoV-2 RNA

Daming Wang #  1   2 , Shaogui He #  3 , Xiaohui Wang  4 , Youqin Yan  5 , Jianzhong Liu  5 , Shimin Wu  6 , Shiguo Liu  7 , Yang Lei  8 , Min Chen  9 , Li Li  9 , Jieli Zhang  8 , Liwei Zhang  8 , Xiao Hu  8 , Xinhui Zheng  8 , Jiawei Bai  8 , Yulong Zhang  10 , Yitong Zhang  11 , Mingxuan Song  12 , Yuguo Tang  13   14
Affiliations

Rapid lateral flow immunoassay for the fluorescence detection of SARS-CoV-2 RNA

Daming Wang et al. Nat Biomed Eng. 2020 Dec.

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has highlighted the need for rapid and accurate nucleic acid detection at the point of care. Here, we report an amplification-free nucleic acid immunoassay, implemented on a lateral flow strip, for the fluorescence detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in less than one hour. The assay uses DNA probes that are designed to bind to the conserved open reading frame 1ab (ORF1ab), envelope protein (E) and the nucleocapsid (N) regions of the SARS-CoV-2 genome, and a fluorescent-nanoparticle-labelled monoclonal antibody that binds to double-stranded DNA-RNA hybrids. In a multi-hospital randomized double-blind trial involving 734 samples (593 throat swabs and 141 sputum) provided by 670 individuals, the assay achieved sensitivities of 100% and specificities of 99% for both types of sample (ground truth was determined using quantitative PCR with reverse transcription). The inexpensive amplification-free detection of SARS-CoV-2 RNA should facilitate the rapid diagnosis of COVID-19 at the point of care.

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Comment in

  • Rapid and frequent testing.
    [No authors listed] [No authors listed] Nat Biomed Eng. 2020 Dec;4(12):1121-1122. doi: 10.1038/s41551-020-00670-0. Nat Biomed Eng. 2020. PMID: 33293723 No abstract available.

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