Diagnostic Testing for the Novel Coronavirus | Infectious Diseases | JN Learning | AMA Ed Hub [Skip to Content]
Outline
Claim CME
PDF
Infection Control

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
Viewpoint
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
Read article on JAMA Network

MOC/CME Information

editorial comment icon
Editorial
Comment
 related articles icon
Related
Articles
 author interview icon
Interviews
 multimedia icon
Multimedia
Audio Author Interview (32:44)
Coronavirus Testing – March 16 Q&A with the CDC’s Jay Butler, MD
Audio (31:22)
Coronavirus Disease 2019 (COVID-19) Update: PCR Testing and Shortages
Video (37:24)
Coronavirus Testing
Read Article Claim CME

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.

Sign in to take quiz and track your certificates

Buy This Activity

JN Learning™ is the home for CME and MOC from the JAMA Network. Search by specialty or US state and earn AMA PRA Category 1 CME Credit™ from articles, audio, Clinical Challenges and more. Learn more about CME/MOC

Related Articles

  1. Coronavirus Infections—More Than Just the Common Cold
    1.00 CME

  2. The 2019 Novel Coronavirus and Challenges for Global Health Governance
    1.00 CME

  3. Coronavirus Outbreak—an Evolving Global Health Emergency

  4. 2019 Novel Coronavirus—Important Information for Clinicians
    1.00 CME

  5. Clinical Characteristics of Patients With Novel Coronavirus (2019-nCoV) Infection Hospitalized in Beijing, China
    1.00 CME

  6. Clinical Characteristics of Patients With 2019 Novel Coronavirus (2019-nCoV)–Infected Pneumonia in Wuhan, China
    1.00 CME

  7. Preparation for Possible Sustained Transmission of 2019 Novel Coronavirus
    1.00 CME

  8. US Emergency Legal Responses to Novel Coronavirus—Balancing Public Health and Civil Liberties
    1.00 CME

  9. The Coronavirus Disease 2019 (COVID-19) Outbreak in China—Summary of a China CDC Report
    1.00 CME

  10. SARS-CoV-2 Contamination of Air, Environmental Surfaces, and Personal Protective Equipment
    1.00 CME

  11. Testing Individuals for COVID-19
    1.00 CME

  12. The Promise and Peril of Antibody Testing for COVID-19
    1.00 CME

  13. Interpreting Diagnostic Tests for SARS-CoV-2
    1.00 CME

  14. COVID-19 and Postinfection Immunity

See More

Related Multimedia

  1. Coronavirus Testing
    0.50 CME

  2. Coronavirus Testing – March 16 Q&A with the CDC’s Jay Butler, MD

  3. Coronavirus Disease 2019 (COVID-19) Update: PCR Testing and Shortages

CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

See More About

Infectious Diseases Infection Control Public Health Pathology and Laboratory Medicine Coronavirus (COVID-19)
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
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
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
6.
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
7.
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
Want full access to the AMA Ed Hub?
Become an AMA member now
After you sign up for AMA Membership, make sure you sign in or create a Physician account with the AMA in order to access all learning activities on the AMA Ed Hub
Buy this activity
Close
Want full access to the AMA Ed Hub?
Become an AMA member now
After you sign up for AMA Membership, make sure you sign in or create a Physician account with the AMA in order to access all learning activities on the AMA Ed Hub
Buy this activity
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
Privacy Policy|Terms of Use
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Close

Lookup An Activity

or

Close

My Saved Searches

You currently have no searches saved.

Close

My Saved Courses

You currently have no courses saved.

Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close
Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue