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.

“The FDA will keep the public informed if significant new information becomes available,” according to the alert.

The Curative test is being used in Los Angeles and other major metropolitan areas, and the company was awarded a contract in November to test federal lawmakers, according to NBC News. The FDA notified Congress about the high rate of false negatives on Monday night, and now, lawmakers are encouraged to follow strict social distancing guidelines this week.

“During the joint session, access to the floor of the House will be limited to those members who are scheduled to speak during the joint session,” according to guidance issued on Tuesday night from the Capitol doctor.

On Wednesday, Curative said it’s still confident in its test and is working with the FDA, according to KXAN, an NBC affiliate in Austin, TX. The test has been available at standalone kiosks and mobile vans throughout Texas.

“This highlights that testing alone won’t get us out of this. We still need to rely heavily on masking, social distancing, hand hygiene, and vaccinating as many Texans as we can,” Diana Fite, MD, president of the Texas Medical Association, told the news outlet.

Show Sources

FDA: “Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication.”

NBC News: “FDA warns Congress about Covid test that may give false results.”

KXAN: “Curative COVID-19 test can have ‘false negative results,’ FDA warns.”

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