FDA warns risk of false negatives with Curative test for COVID-19

UNITED STATES — On Jan. 4, The U.S. Food and Drug Administration (FDA) released a safety communication, alerting patients and health care providers of the risk of false results, particularly false-negative results, with the Curative SARS-Cov-2 test.

Curative COVID-19 testing sites are located in Jackson at the Deloney bus shelter, and in Teton Village at the Cody Parking lot. The free testing sites are managed by the Teton County Health Department. The town describes them as “business surveillance testing.”

For community members who are using the testing kiosks without experiencing symptoms, they may receive a false negative. The Curative website provides an EU summary of the intended use of the test, “collection of nasal swabs and oral fluid specimens is limited to symptomatic individuals within 14 days of COVID-19 symptom onset.”

The FDA warns that “A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19.” Patients are urged to consult a health care professional with concerns about test results.

Health care providers are urged to consider retesting patients using a different test if inaccurate results are suspected and the results were given recently. If testing was performed more than two weeks ago, and there is no reason to suspect a current SARS-CoV-2 infection, it is not necessary to retest.

Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in an increased risk of spread of COVID-19 within the community, or other unintended adverse events.


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