Unapproved COVID-19 test can give false negatives, Mecklenburg health director warns
At least one rapid test for COVID-19 not approved by federal regulators is being used in Mecklenburg County and could lead to misleading results, public health officials said.
“It has a very low sensitivity early in the illness, which means a higher likelihood of a false negative result,” Public Health Director Gibbie Harris said in a statement about the tests, which are not approved by the Food and Drug Administration. “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, Harris said.
North Carolina has at least 4,359 reported cases of the coronavirus and 87 deaths as of Saturday afternoon, according to state and county records.
Mecklenburg County has 933 reported cases, the most in the state, and 12 deaths.
County health officials did not specify where the non-approved rapid tests were being done locally.
But a west Charlotte urgent care clinic recently has gotten local attention for advertising a “five-minute COVID-19 test” prominently on its website.
StarMed Family and Urgent Care on Tuckaseegee Road acknowledges its “drive-thru” test is not FDA approved and said it is charging $50 per test until the test is approved, at which point the cost “should be covered by insurance.”
In a document on its website explaining its test, StarMed defended using a test not approved by the FDA.
“We can either sit by and stare at the problem or we can be part of the solution,” the statement read.
“Those that take the time to properly study all aspects of this pandemic will see that this is a good and viable option for our country to mass test right now. We expect to take criticism from those that are misinformed. It does not matter to us since we know we are doing the right thing for our community.”
StarMed officials did not immediately respond to a request for comment on Saturday.
Harris, the county health director, said it matters what kind of tests are used.
“Accurate, rapid testing is coming,” Harris said in the statement. “However, this test is probably doing more harm than good right now.”
County health officials encouraged people experiencing COVID-19 symptoms, including fever, cough and shortness of breath, to call their healthcare provider or the county health department.
If someone meets testing criteria, they should be tested with methods approved by state health officials and local hospitals, Harris said.
More information about COVID-19 is available on Mecklenburg’s website, mecknc.gov/covid-19, or by calling 980-314-9400.
This work was made possible in part by grant funding from Report for America/GroundTruth Project and the Foundation For The Carolinas.
This story was originally published April 11, 2020 at 11:12 AM.
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