The COVID-19 pandemic has highlighted that new diagnostic technologies are essential for controlling disease transmission. Here, we develop SHINE (SHERLOCK and HUDSON Integration to Navigate Epidemics), a sensitive and specific integrated diagnostic tool that can detect SARS-CoV-2 RNA from unextracted samples. We combine the steps of SHERLOCK into a single-step reaction and optimize HUDSON to accelerate viral inactivation in nasopharyngeal swabs and saliva. SHINE's results can be visualized with an in-tube fluorescent readout - reducing contamination risk as amplification reaction tubes remain sealed - and interpreted by a companion smartphone application. We validate SHINE on 50 nasopharyngeal patient samples, demonstrating 90% sensitivity and 100% specificity compared to RT-PCR with a sample-to-answer time of 50 minutes. SHINE has the potential to be used outside of hospitals and clinical laboratories, greatly enhancing diagnostic capabilities.

中文翻译：

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集成的样品灭活，扩增和基于Cas13的SARS-CoV-2检测。

COVID-19大流行病突出表明，新的诊断技术对于控制疾病的传播至关重要。在这里，我们开发了SHINE（SHERLOCK和HUDSON集成以导航流行病），这是一种灵敏而特异的集成诊断工具，可以检测未提取样品中的SARS-CoV-2 RNA。我们将SHERLOCK的步骤合并为一个单一步骤的反应，并优化HUDSON以加速鼻咽拭子和唾液中的病毒灭活。SHINE的结果可以通过管内荧光读数进行可视化-由于扩增反应管保持密封，从而降低了污染风险-并可以通过智能手机应用程序进行解释。我们对50例鼻咽患者样本进行了SHINE验证，与RT-PCR相比，在50分钟的应答时间内证明了90％的敏感性和100％的特异性。