Review of analytical performance of COVID-19 detection methods
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REVIEW
Review of analytical performance of COVID-19 detection methods Basant Giri 1 & Shishir Pandey 1 & Retina Shrestha 1 & Krisha Pokharel 1 & Frances S. Ligler 2 & Bhanu B. Neupane 1,3 Received: 2 July 2020 / Revised: 11 August 2020 / Accepted: 14 August 2020 # The Author(s) 2020
Abstract 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. Keywords Coronavirus . SARS-CoV-2 . COVID-19 . RT-PCR . Immunoassays . Disease diagnosis
Introduction The coronavirus disease 2019 (COVID-19) follows multiple past epidemics caused by highly transmissible respiratory viral infections. COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that was first reported in Wuhan, China [1], and spread into a public health emergency worldwide. Public health experts have emphasized testing as many individuals as possible, tracking infected people, and tracing their contacts as an effective strategy to reduce the spread of the virus. Most of the governments across the globe are
* Frances S. Ligler [email protected] 1
Center for Analytical Sciences, Kathmandu Institute of Applied Sciences, Kathmandu 44600, Nepal
2
Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh, NC 27695, USA
3
Central Department of Chemistry, Tribhuvan University, Kathmandu 44618, Nepal
exercising this practice to variable extent using an array of testing methods. The SARS-CoV-2 is a positive-sense single-stranded RNA β family coronavirus that is genetically similar to SARS coronavirus and bat SARS-like coronaviruses [2]. Each virion is 50–200 nm in diameter and consists of four structural proteins
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