FDA Warns Curative’s COVID-19 Test Might Give False Negative Results

The U.S. Food and Drug Administration (FDA) issued a notice this week warning the public and health care providers of the potential risk for getting false negative results from the Curative company’s test for COVID-19.

Curative’s SARS-Cov-2 Assay is a prescription-only test used to detect the presence of the novel coronavirus that causes COVID-19. The test is used by collecting a throat swab, nasopharyngeal swab, nasal swab or oral fluid specimen from a person who is suspected of being infected. Under the federal Emergency Use Authorization Act, specimens collected using Curative’s test kits are processed at KorvaLabs Inc. in California and results are sent directly to patients.

The FDA’s warning about the potential for false negative results was general and offered no specific explanation. FDA officials did not announce what prompted the alert.

The only other information offered by the agency was a directive stressing the importance of using the Curative tests according to their package labeling and instructions.

Tests must be “limited to individuals who have shown symptoms of COVID-19 within 14 days of onset of the symptoms,” the FDA’s statement said. “Specimen collection must be directly observed… by a trained health care worker at the specimen collection site.”

Tests administered to patients outside the parameters called for by the Curative test and without the direction of trained health care workers run a higher risk of returning with false negative test results, the FDA said.

False negative test results can be dangerous if they are relied on to make decisions about care, according to the FDA’s warning. Delaying or withholding supportive treatment can result in increased COVID-19 systems and greater spread of the infection to others.

The Seattle Times reported Curative CEO Fred Turner was made aware of the FDA’s notice and was working “to provide more information soon.”

“We are confident in our data and we are working with the FDA closely on the matter,” Turner was quoted by The Seattle Times as saying. “Testing sensitivity and accuracy on behalf of our patients is at the heart of our work.”

In dozens of cities throughout the U.S., self-testing centers have been set up, many using Curative test kits. Patients perform the nasal, throat or oral swabbing themselves, on site and under the direction of health care workers.

Even so, it can be possible for an untrained person to fail to collect enough material with the swab to ensure an accurate result.

The FDA’s warning says a negative test “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.”

Health care providers are being urged to consider retesting patients who have received a suspected false negative test the first time if the test was administered within two weeks of the results being reported, according to WebMD. The second test should be of a different variety, the FDA says.

If the false negative is suspected after two weeks have passed from the testing date, a second test is not necessary, according to the FDA.

Have you been tested using a Curative test for COVID-19? Did you get a negative test result? Tell us about it in the comment section below.

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