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Review
. 2020 Jul 23;58(8):e00797-20.
doi: 10.1128/JCM.00797-20. Print 2020 Jul 23.

The Role of Antibody Testing for SARS-CoV-2: Is There One?

Elitza S Theel  1 , Patricia Slev  2   3 , Sarah Wheeler  4 , Marc Roger Couturier  2   3 , Susan J Wong  5 , Kamran Kadkhoda  6
Affiliations
Review

The Role of Antibody Testing for SARS-CoV-2: Is There One?

Elitza S Theel et al. J Clin Microbiol. .

Abstract

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) brought with it rapid development of both molecular and serologic assays for identification of COVID-19 infections. While Food and Drug Administration (FDA) emergency use authorization (EUA) is required for clinical application of SARS-CoV-2 molecular tests, submission for EUA is currently a voluntary process for manufacturers of serologic assays. The absence of FDA oversight of serologic tests is concerning given that the commercially available serologic assays are highly variable, differing in their format, the antibody class detected, the targeted antigen, and the acceptable specimen types. An added complication is the lack of a clear understanding for how such assays should be utilized and what the reported results ultimately indicate or, perhaps more importantly, what they do not indicate. Here, we provide a brief summary of the performance of a number of serologic assays reported in the literature, comment on what we do and do not know regarding our immune response to SARS-CoV-2, and provide a number of scenarios for which serologic testing will play a role during our global response to this pandemic.

Keywords: COVID-19; SARS-CoV-2; antibody; serology.

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References

    1. Gorbalenya AE, Baker SC, Baric RS, de Groot RJ, Drosten C, Gulyaeva AA, Haagmans BL, Lauber C, Leontovich AM, Neuman BW, Penzar D, Perlman S, Poon LLM, Samborskiy DV, Sidorov IA, Sola I, Ziebuhr J, Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. 2020. The species severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol 5:536–544. - PMC - PubMed
    1. CDC. 2020. Testing for COVID-19. CDC, Atlanta, GA: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html. Accessed 5 April 2020.
    1. FDA. 2020. FAQs on diagnostic testing for SARS-CoV-2. FDA, Washington, DC: https://www.fda.gov/medical-devices/emergency-situations-medical-devices.... Accessed 5 April 2020.
    1. FDA. 2020. Emergency use authorizations. FDA, Washington, DC: https://www.fda.gov/medical-devices/emergency-situations-medical-devices.... Accessed 5 April 2020.
    1. Gorse GJ, Patel GB, Vitale JN, O'Connor TZ. 2010. Prevalence of antibodies to four human coronaviruses is lower in nasal secretions than in serum. Clin Vaccine Immunol 17:1875–1880. doi:10.1128/CVI.00278-10. - DOI - PMC - PubMed

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