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Review
. 2021;20(4):166-174.
doi: 10.1007/s11901-021-00567-9. Epub 2021 Oct 28.

Diagnostic Testing for SARS-CoV-2 Infection

Emmanuel Thomas  1   2 , Stephanie Delabat  1 , David M Andrews  3
Affiliations
Review

Diagnostic Testing for SARS-CoV-2 Infection

Emmanuel Thomas et al. Curr Hepatol Rep. 2021.

Abstract

Purpose of review: Given the rapid development of diagnostic approaches to test for and diagnose infection with SARS-CoV-2, many options are available to assess infection. Multiple established diagnostic companies are now providing testing platforms whereas initially, testing was being performed with simple PCR-based tests using standard laboratory reagents.

Recent findings: Additional testing platforms continue to be developed but challenges with testing, including obtaining testing reagents and other related supplies, are frequently encountered. With time, the testing supply chain will improve and more companies will be providing materials to support these testing efforts. In the USA, the need for rapid assay development and subsequent approval through attainment of emergency use authorization (EUA) has superseded the traditional arduous diagnostic testing approval workflow mandated by the FDA. It is anticipated that the USA will be able to continue to significantly increase its testing capabilities to address this pandemic; however, challenges remain due to the diversity of the performance characteristics of tests being utilized.

Summary: This review provides an overview of the current diagnostic testing landscape, with pertinent information related to SARS-CoV-2 virology and antibody responses, that is available to diagnose infection.

Keywords: Antibody; Antigen; COVID-19; Nucleic acids; PCR; SARS-CoV-2.

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Conflict of interest statement

Conflict of InterestEmmanuel Thomas, Stephanie Delabat, and David M. Andrews declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
The SARS-CoV-2 genome and antibody responses. A SARS-CoV-2 RNA genome (30 kB) and its coding regions encoding both non-structural and structural proteins. B Theoretical antibody responses in humans following both primary and secondary infections with SARS-CoV-2
See this image and copyright information in PMC

References

    1. Randall RE, Griffin DE. Within host RNA virus persistence: mechanisms and consequences. Curr Opin Virol. 2017;23:35–42. doi: 10.1016/j.coviro.2017.03.001. - DOI - PMC - PubMed
    1. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res. 2011;81:85–164. doi: 10.1016/B978-0-12-385885-6.00009-2. - DOI - PMC - PubMed
    1. Gao H, et al. From SARS to MERS: evidence and speculation. Front Med. 2016;10(4):377–382. doi: 10.1007/s11684-016-0466-7. - DOI - PMC - PubMed
    1. Kiyuka PK, et al. Human coronavirus NL63 molecular epidemiology and evolutionary patterns in rural coastal Kenya. J Infect Dis. 2018;217(11):1728–1739. doi: 10.1093/infdis/jiy098. - DOI - PMC - PubMed
    1. Liu W, et al. Two-year prospective study of the humoral immune response of patients with severe acute respiratory syndrome. J Infect Dis. 2006;193(6):792–795. doi: 10.1086/500469. - DOI - PMC - PubMed

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