J-LSMS | Research | SARS-CoV-2

clinical-specimens.html 6. Wölfel, R., Corman, V. M., Guggemos, W., Seilmaier, M., Zange, S., Müller, M. A., Niemeyer, D., Jones, T. C., Vollmar, P., Rothe, C., Hoelscher, M., Bleicker, T., Brünink, S., Schneider, J., Ehmann, R., Zwirglmaier, K., Drosten, C., & Wendtner, C. (2020). Virological assessment of hospitalized patients with COVID-2019. Nature, 581(7809), 465–469. https://doi. org/10.1038/s41586-020-2196-x 7. Hanson, K. E., Caliendo, A. M., Arias, C. A., Englund, J. A., Hayden, M. K., Lee, M. J., Loeb, M., Patel, R., Altayar, O., El Alayli, A., Sultan, S., Falck-Ytter, Y., Lavergne, V., Morgan, R. L., Murad, M. H., Bhimraj, A., & Mustafa, R. A. (2020). Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Serologic Testing. Clinical Infectious Diseases, 1–18. https://doi.org/10.1093/cid/ ciaa1343 8. Fang, F. C., Naccache, S. N., & Greninger, A. L. (2020). The Laboratory Diagnosis of Coronavirus Disease 2019— Frequently Asked Questions. Clinical Infectious Diseases, 71(11), 2996–3001. https://doi.org/10.1093/cid/ciaa742

virus to prevent infection or how long such a protective response might exist 7 .

Of note, currently available messenger RNA platform COVID-19 vaccines (produced by Pfizer and Moderna) generate a neutralizing antibody response to the spike protein. As such, these vaccinations will likely yield positive results for serologic assays that detect antibodies to the spike protein but not those that detect antibodies to the viral nucleocapsid. General responses in vaccinated patients to commercially available serologic assays are currently being studied and additional guidance is likely forthcoming

in the near future. CONCLUSIONS

In conclusion, given the profound impact of SARS-CoV-2 infection worldwide and its ongoing high prevalence in our local community, healthcare providers should have a low threshold for diagnostic testing to confirm COVID-19 in patients with any concerning symptoms. NAAT assays and antigen testing are the major diagnostics utilized to confirm active infection with SARS-CoV-2. Negative test results with rapid NAAT assays and lower sensitivity antigen diagnostics should be confirmed with a high sensitivity RT- PCR NAAT assay when suspicion for infection remains high. Antibody testing is used to confirm prior recent infection but cannot confirm immunity to SARS-CoV-2. Future areas of study will likely include development of increasingly accurate rapid diagnostics and commercial serologic assays that can detect neutralizing antibodies that confer durable immunity to SARS-CoV-2. REFERENCES 1. Struyf, T., Deeks, J. J., Dinnes, J., Takwoingi, Y., Davenport, C., Leeflang, M. M. G., Spijker, R., Hooft, L., Emperador, D., Dittrich, S., Domen, J., Horn, S. R. A., & Van den Bruel, A. (2020). Signs and symptoms to determine if a patient presenting in primary care or hospital outpatient settings has COVID-19 disease. Cochrane Database of Systematic Reviews, 7. https://doi.org/10.1002/14651858.cd013665 2. IDSA. (2020, March). COVID-19 Prioritization of Diagnostic Testing. https://www.idsociety.org/globalassets/idsa/public- health/covid-19-prioritization-of-dx-testing.pdf 3. Hanson, K. E., Caliendo, A. M., Arias, C. A., Hayden, M. K., Englund, J. A., Lee, M. J., Loeb, M., Patel, R., El Alayli, A., Altayar, O., Patel, P., Falck-Ytter, Y., Lavergne, V., Morgan, R. L., Murad, M. H., Sultan, S., Bhimraj, A., & Mustafa, R. A. (2021). The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing. Clinical Infectious Diseases, 8. https://doi.org/10.1093/cid/ciab048 4. CDC. (2020, December). Interim Guidance for Antigen Testing for SARS-CoV-2. https://www.cdc.gov/coronavirus/2019-ncov/ lab/resources/antigen-tests-guidelines.html 5. CDC. (2021, January). Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19. https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-

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