Center for Analytical Sciences, Kathmandu Institute of Applied Sciences, Kathmandu, 44600, Nepal.
Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh, NC, 27695, USA.
Anal Bioanal Chem. 2021 Jan;413(1):35-48. doi: 10.1007/s00216-020-02889-x. Epub 2020 Sep 18.
In the recent SARS-CoV-2 pandemic, public health experts have emphasized testing, tracking infected people, and tracing their contacts as an effective strategy to reduce the spread of the virus. Several diagnostic methods are reported for detecting the coronavirus in clinical, research, and public health laboratories. Some tests detect the infection directly by detecting the viral RNA and other tests detect the infection indirectly by detecting the host antibodies. A diagnostic test during the pandemic should help make an appropriate clinical decision in a short period of time. Recently reported diagnostic methods for SARS-CoV-2 have varying throughput, batching capacity, requirement of infrastructure setting, analytical performance, and turnaround times ranging from a few minutes to several hours. These factors should be considered while selecting a reliable and rapid diagnostic method to help make an appropriate decision and prompt public health interventions. This paper reviews recent SARS-CoV-2 diagnostic methods published in journals and reports released by regulatory agencies. We compared the analytical efficiency including limit of detection, sensitivity, specificity, and throughput. In addition, we also looked into ease of use, affordability, and availability of accessories. Finally, we discuss the limitations of the methods and provide our perspectives on priorities for future test development.
在最近的 SARS-CoV-2 大流行中，公共卫生专家强调了检测、追踪感染人群及其接触者，这是减少病毒传播的有效策略。目前已有多种诊断方法用于在临床、研究和公共卫生实验室中检测冠状病毒。一些检测方法通过检测病毒 RNA 直接检测感染，而其他检测方法通过检测宿主抗体间接检测感染。在大流行期间，诊断检测应有助于在短时间内做出适当的临床决策。最近报道的 SARS-CoV-2 诊断方法在通量、批量处理能力、基础设施设置要求、分析性能和周转时间等方面各不相同，从几分钟到几个小时不等。在选择可靠且快速的诊断方法时，应考虑这些因素，以帮助做出适当的决策并及时进行公共卫生干预。本文综述了期刊上发表的和监管机构发布的报告中最近报道的 SARS-CoV-2 诊断方法。我们比较了分析效率，包括检测限、灵敏度、特异性和通量。此外，我们还研究了操作的简便性、价格的可负担性和配件的可用性。最后，我们讨论了这些方法的局限性，并就未来测试开发的重点提出了我们的看法。
