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COVID-19: Updated Testing Guidance; New, Expanded Emergency Use Authorizations

New Centers for Disease Control and Prevention guidelines edit the criteria required for COVID-19 testing. The agency now says asymptomatic people who have been in close contact — within six feet — of a person with a COVID-19 infection do not need a test, unless they are a vulnerable individual or are encouraged by state or local public health officials to receive a test.

FDA Expands Remdesivir Emergency Use Authorization

The Food and Drug Administration (FDA) on Aug. 28 broadened the scope of its existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to treat COVID-19

Originally issued in May 2020, the EUA authorized the use of intravenous Veklury for hospitalized adult and pediatric patients with severe COVID-19. The initial EUA defined “severe disease” as patients with low blood oxygen levels or patients needing oxygen therapy or more intensive breathing support, such as a ventilator. Now, Veklury may be used for treatment of all hospitalized patients, regardless of the severity of their disease.

In announcing the EUA expansion, the agency cited promising results in a randomized, double-blind trial conducted by the National Institute of Allergy and Infectious Diseases, as well as a multisite study evaluating the drug’s use to treat moderate COVID-19. Several essential hospitals participated in the study, including:

  • Cook County General Hospital, in Chicago;
  • University of Chicago, in Chicago;
  • IU Health Methodist Hospital, in Indianapolis;
  • Tufts Medical Center, in Boston;
  • Henry Ford Health System, in Detroit;
  • Hennepin Healthcare, in Minneapolis;
  • St. Joseph’s University Medical Center, in Paterson, N.J.;
  • Temple University Hospital, in Philadelphia;
  • University of Utah Health, in Salt Lake City; and
  • VCU Health Medical Center, in Richmond, Va.

FDA released fact sheets about the drug for health care providers and patients.

New Emergency Use Authorization for Antigen Test with Instant Results

FDA on Aug. 26 issued an EUA for the first antigen test from which results can be read directly from the testing card. Developed by Abbott Diagnostics, the BinaxNOW COVID-19 Ag Card functions similarly to many pregnancy tests. After swabbing the patient’s nose, a health care provider twirls the sample on a test card with a reagent added. The results appear on the card after 15 minutes: one line for a negative result, and two lines for a positive result.

This test has been authorized for use in patients suspected of COVID-19 within seven days of symptom onset. Abbott plans to make up to 50 million tests available monthly in the United States in October.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the outbreak.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Emily Schweich is a senior communications associate for America's Essential Hospitals.

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