Molecular Diagnostics Laboratory, Fralin Biomedical Research Institute, Virginia Tech, Roanoke, VA, USA.
Center for Glial Biology in Health, Disease, and Cancer, Fralin Biomedical Research Institute at VTC, Roanoke, VA, USA.
Nat Commun. 2021 Jul 20;12(1):4400. doi: 10.1038/s41467-021-24552-4.
Rapid and widespread testing of severe acute respiratory coronavirus 2 (SARS-CoV-2) is essential for an effective public health response aimed at containing and mitigating the coronavirus disease 2019 (COVID-19) pandemic. Successful health policy implementation relies on early identification of infected individuals and extensive contact tracing. However, rural communities, where resources for testing are sparse or simply absent, face distinctive challenges to achieving this success. Accordingly, we report the development of an academic, public land grant University laboratory-based detection assay for the identification of SARS-CoV-2 in samples from various clinical specimens that can be readily deployed in areas where access to testing is limited. The test, which is a quantitative reverse transcription polymerase chain reaction (RT-qPCR)-based procedure, was validated on samples provided by the state laboratory and submitted for FDA Emergency Use Authorization. Our test exhibits comparable sensitivity and exceeds specificity and inclusivity values compared to other molecular assays. Additionally, this test can be re-configured to meet supply chain shortages, modified for scale up demands, and is amenable to several clinical specimens. Test development also involved 3D engineering critical supplies and formulating a stable collection media that allowed samples to be transported for hours over a dispersed rural region without the need for a cold-chain. These two elements that were critical when shortages impacted testing and when personnel needed to reach areas that were geographically isolated from the testing center. Overall, using a robust, easy-to-adapt methodology, we show that an academic laboratory can supplement COVID-19 testing needs and help local health departments assess and manage outbreaks. This additional testing capacity is particularly germane for smaller cities and rural regions that would otherwise be unable to meet the testing demand.
快速广泛地检测严重急性呼吸冠状病毒 2（SARS-CoV-2）对于有效的公共卫生应对至关重要，目的是遏制和减轻 2019 年冠状病毒病（COVID-19）大流行。成功实施卫生政策依赖于早期识别感染者和广泛的接触者追踪。然而，资源匮乏或根本不存在检测资源的农村社区，在实现这一成功方面面临着独特的挑战。因此，我们报告了一种基于学术性、公立赠地大学实验室的检测方法的开发，用于鉴定来自各种临床标本的 SARS-CoV-2，该方法可以在检测受限的地区迅速部署。该测试是一种基于定量逆转录聚合酶链反应（RT-qPCR）的程序，在州立实验室提供的样本和提交给 FDA 紧急使用授权的样本上进行了验证。与其他分子检测相比，我们的检测具有相当的灵敏度，并且超过了特异性和包容性值。此外，该测试可以重新配置以应对供应链短缺，进行规模扩大的需求调整，并且适用于几种临床标本。测试开发还涉及 3D 工程关键供应品和制定稳定的收集介质，允许样本在分散的农村地区运输数小时而无需冷链。当测试受到影响且人员需要到达与测试中心地理隔离的地区时，这两个要素至关重要。总的来说，我们使用稳健、易于适应的方法表明，学术实验室可以补充 COVID-19 检测需求，并帮助地方卫生部门评估和管理疫情。对于那些否则无法满足检测需求的小城市和农村地区来说，这种额外的检测能力尤为重要。
