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.

2019年冠状病毒病（COVID-19）大流行凸显了在护理时需要快速准确的核酸检测的必要性。在这里，我们报告在侧流试纸上实施的无扩增核酸免疫测定法，用于在不到一小时的时间内对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）RNA进行荧光检测。该测定法使用的DNA探针旨在与SARS-CoV-2基因组的保守开放阅读框1ab（ORF1ab），包膜蛋白（E）和核衣壳（N）区域以及荧光纳米颗粒标记的单克隆抗体结合与双链DNA–RNA杂交体结合的抗体。在一项多院随机双盲试验中，由670名个体提供了734个样本（593个咽拭子和141个痰液），该测定对两种类型的样品均实现了100％的灵敏度和99％的特异性（使用反转录定量PCR测定了底物）。廉价的无扩增SARS-CoV-2 RNA的检测应有助于在护理时快速诊断COVID-19。