County Officials Warn Public About Misleading Coronavirus Tests

CHARLOTTE, NORTH CAROLINA — Mecklenburg County Public Health is warning residents that some rapid tests for coronavirus may provide misleading results, giving test takers a false sense of security that they are safe and not infectious.

"There is at least one non-FDA approved test being used in our community," said Public Health Director Gibbie Harris. "It has a very low sensitivity early in the illness which means a higher likelihood of a false negative result. This could increase the risk that an infectious person would spread the disease."

The North Carolina Department of Health and Human Services currently does not accept positive results from non-FDA approved tests. Positive results could be due to current or past infections from viruses other than coronavirus, said health officials.

"Accurate, rapid testing is coming," said Harris. "However, this test is probably doing more harm than good right now."

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Harris said residents who have symptoms of coronavirus—fever, coughing and shortness of breath—should reach out to their health care provider or Mecklenburg County Public Health. If they fit the criteria, they should be tested using methods approved by the FDA and accepted by the North Carolina Division of Public Health and local hospitals.

The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer coronavirus tests across the U.S. but is maintaining oversight to ensure the tests are accurate.

"It’s critical that the tests used work," said the FDA in a news release. "False results can also contribute to the spread of COVID-19."

An "emergency use authorization," put into place by Congress, is a relaxed standard that allows tests to be made available based on less data than in non-urgent circumstances and provides for an expedited FDA review. In many cases, the FDA can do this review in as little as a day.

Since the beginning of January, the FDA has worked with more than 230 test developers who have or are expected to submit requests for FDA emergency authorization of their tests. To date, 20 authorizations have been granted.

For a complete list of FDA-approved coronavirus tests, click here.

For resources on coronavirus in Mecklenburg County, visit the county's website. Individuals can also call the county’s coronavirus hotline at 980-314-9400.

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