FDA Issues Safety Communication About Risk of False Results with the Curative Test for COVID-19

On January 4, 2021, the U.S. Food and Drug Administration (FDA) alerted health care practitioners of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. The FDA is urging physicians to consider retesting patients using a different test if they suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test.

What should physicians know?

Consistent with the test’s authorized labeling, collection of nasal swabs and oral fluid specimens is limited to individuals who have shown symptoms of COVID-19 within 14 days of onset of the symptoms. The FDA indicated that many false negatives were associated with asymptomatic patients. Consistent with the EUA summary, negative results for SARS-CoV-2 RNA from oral fluid specimens should be confirmed by testing of another specimen type authorized for use with this test if clinically indicated. Read the FDA Safety Communication Summary.

How might this impact Montgomery County?

On December 8, 2020, Washington DC announced that its free COVID-19 testing sites at Judiciary Square and Nationals Park would switch over to the Curative test, to help cover the spike in average tests per week from 10,000 to 25,000.

The Office of the Attending Physician has also been offering the Curative test to members, staff and reporters on Capitol Hill since at least November. The service, which typically offers results within 12 hours, is used by dozens, if not hundreds, of people a day when Congress is in session. Curative also holds a $42-million contract to perform testing in U.S. military treatment facilities, some of which are located in Montgomery County.

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