FDA Warns About False Negatives from COVID-19 Test

By Carolyn Crist

Jan. 6, 2021 — The FDA issued a safety alert Monday about the potential for false results from a rapid COVID-19 test made by Curative Inc. False negative results, in particular, have been a concern.

“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 increased risk of spread of COVID-19 within the community,” the FDA wrote.

To reduce the risk of false negatives, the FDA emphasized the importance of following the test’s guidelines. Swabs should be limited to patients who have COVID-19 symptoms and who test within 14 days of when their symptom start, and trained health care workers should oversee the sample collection.

Also, a negative result doesn’t rule out COVID-19 and shouldn’t be used as the sole basis for treatment or patient management, the FDA wrote. Health care providers should consider retesting their patients with a different test if they suspect the Curative test gives an inaccurate result. Patients should also talk to their health care providers if they think they received the Curative test and have concerns.

The FDA also encouraged health care providers and patients to report problems with the Curative test, including suspected inaccurate results.

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