Diagnostic Testing for the Novel Coronavirus

JAMA - Journal of the American Medical Association

Volumn 323, Issue 15, 2020, Pages 1437-1438

  Sharfstein, Joshua M ^a   Becker, Scott J ^b   Mello, Michelle M ^c  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b ASSOCIATION OF PUBLIC HEALTH LABORATORIES   (United States)

^c STANFORD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACT; CLINICAL LABORATORY; CLINICAL PROTOCOL; CONTACT EXAMINATION; CORONAVIRUS DISEASE 2019; CORONAVIRUS INFECTION; DIAGNOSTIC TEST; DISEASE COURSE; DRIVE THROUGH TESTING; EARLY DIAGNOSIS; EPIDEMIOLOGICAL MONITORING; FOOD AND DRUG ADMINISTRATION; HUMAN; INCUBATION TIME; LABORATORY TEST; MASS SCREENING; NOTE; POPULATION EXPOSURE; PRIORITY JOURNAL; PROJECT BIOSHIELD ACT OF 2004; PUBLIC HEALTH SERVICE; PUBLIC POLICY; RESPIRATORY TRACT DISEASE; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SARS-RELATED CORONAVIRUS; SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2; UNITED STATES; VERIFYING ACCURATE LEADING EDGE IVCT DEVELOPMENT; VIRUS TRANSMISSION; WORLD HEALTH ORGANIZATION; BETACORONAVIRUS; GOVERNMENT REGULATION; HEALTH CARE DELIVERY; LABORATORY TECHNIQUE; PANDEMIC; VIRUS PNEUMONIA;

BETACORONAVIRUS; CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S.; CLINICAL LABORATORY TECHNIQUES; CORONAVIRUS INFECTIONS; GOVERNMENT REGULATION; HEALTH SERVICES ACCESSIBILITY; HUMANS; PANDEMICS; PNEUMONIA, VIRAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85081733108     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2020.3864     Document Type: Note

References (7)

1. 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
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6. Caliendo AM, Couturier MR, Ginocchio CC,; 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/ciw260 27118790
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