The FDA issued an alert Thursday about a COVID-19 rapid diagnostic test that's being used and promoted by the White House.
The test, made by Abbott Laboratories, can provide results in five to 13 minutes. It was fast-tracked for use by the FDA last month.
But now the agency is warning about the test's reliability, saying it may be giving "false negative results."
The FDA's alert comes after researchers with NYU Langone Health identified accuracy issues with the Abbott ID NOW test. Their study looked at 101 test swabs done with a different testing system. Thirty-one of those swabs tested positive. But the Abbott test missed almost half of those positive results. Researchers said the findings were "unacceptable."
The FDA now cautions that, "Any negative [Abbott] test results that are not consistent with a patient’s clinical signs and symptoms or necessary for patient management should be confirmed with another test."
Nevertheless, Health and Human Services Secretary Alex Azar said Friday that the Trump administration still has "confidence in the test." The White House is using the speedy coronavirus test to screen President Trump and others in the West Wing every day.
Abbott has questioned whether researchers are using its test correctly. It says it plans to clarify instructions for its customers.
Contains footage from CNN.
