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Infectious Diseases

Diagnostic Testing for the Novel Coronavirus

Educational Objective
Understand the importance of diagnostic testing in combating COVID-19
1 Credit CME
JAMA
April 21, 2020
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Joshua M. Sharfstein, MD1; Scott J. Becker, MS2; Michelle M. Mello, JD, PhD3 Author Affiliations
  • 1Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 2Association of Public Health Laboratories, Silver Spring, Maryland
  • 3Stanford Law School and the Center for Health Policy/Primary Care and Outcomes Research, Department of Medicine, Stanford University School of Medicine, Stanford, California
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Coronavirus Testing
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Controversies over diagnostic testing have dominated US headlines about severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus responsible for coronavirus disease 2019 (COVID-19). Technical challenges with the first test developed by the Centers for Disease Control and Prevention (CDC) left the nation with minimal diagnostic capacity during the first few weeks of the epidemic. The CDC also initially limited access to testing to a narrow group of individuals with known exposure. The delayed discovery of a case of COVID-19 in California, followed quickly by evidence of community transmission in multiple states, revealed the shortcomings of this strategy. In the early stages, COVID-19 has spread beyond the nation’s ability to detect it.

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Infectious Diseases Pulmonary Medicine Infection Control Public Health Pathology and Laboratory Medicine Coronavirus (COVID19)
Article Information

Corresponding Author: Joshua M. Sharfstein, MD, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Room W1033F, Baltimore, MD 21205 (joshua.sharfstein@jhu.edu).

Published Online: March 9, 2020. doi:10.1001/jama.2020.3864

Conflict of Interest Disclosures: Dr Mello reported receiving grants from the Greenwall Foundation, a nonprofit foundation focused on bioethics. No other disclosures were reported.

Additional Information: Dr Sharfstein reported serving as Principal Deputy Commissioner of the US Food and Drug Administration from March 2009 to January 2011.

References
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US Food and Drug Administration. Policy for diagnostics testing in laboratories certified to perform high complexity testing under CLIA prior to emergency use authorization for coronavirus disease-2019 during the public health emergency. February 29, 2020. Accessed March 5, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-laboratories-certified-perform-high-complexity-testing-under-clia-prior
2.
US Food and Drug Administration. Letter from RADM Denise M. Hinton, Chief Scientist, to Robert R. Redfield, Director, Centers for Disease Control and Prevention. March 2, 2020. https://www.fda.gov/media/135763/download
3.
US Food and Drug Administration. Information for laboratories implementing IVD tests under EUA. March 1, 2020. Accessed March 5, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/information-laboratories-implementing-ivd-tests-under-eua
4.
Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018, 115th Cong (2018), 2nd Sess. https://bucshon.house.gov/uploadedfiles/valid_act_discussion_draft_12.6.18.pdf
5.
Hellewell  J , Abbott  S , Gimma  A ,  et al; Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group.  Feasibility of controlling COVID-19 outbreaks by isolation of cases and contacts.   Lancet Glob Health. 2020;S2214-109X(20)30074-7. Published online February 28, 2020. doi:10.1016/S2214-109X(20)30074-7PubMedGoogle Scholar
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Caliendo  AM , Couturier  MR , Ginocchio  CC ,  et al; Infectious Diseases Society of America; the American Society for Microbiology; and the Pan-American Society for Clinical Virology.  Maintaining life-saving testing for patients with infectious diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology recommendations on the regulation of laboratory-developed tests.   Clin Infect Dis. 2016;63(2):151-154. doi:10.1093/cid/ciw260PubMedGoogle ScholarCrossref
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US Centers for Disease Control and Prevention. Evaluating and reporting persons under investigation (PUI). March 4, 2020. Accessed March 6, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html
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