Diagnostic Testing for the Novel Coronavirus

Author:

Sharfstein Joshua M.1,Becker Scott J.2,Mello Michelle M.3

Affiliation:

1. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland

2. Association of Public Health Laboratories, Silver Spring, Maryland

3. Stanford Law School and the Center for Health Policy/Primary Care and Outcomes Research, Department of Medicine, Stanford University School of Medicine, Stanford, California

Publisher

American Medical Association (AMA)

Subject

General Medicine

Reference7 articles.

1. Feasibility of controlling COVID-19 outbreaks by isolation of cases and contacts.;Hellewell;Lancet Glob Health,2020

2. 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.;Caliendo;Clin Infect Dis,2016

3. 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

4. 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

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