Mecklenburg Co. issues warning on non-FDA approved COVID-19 test being offered locally

Mecklenburg Co. issues warning on non-FDA approved COVID-19 test being offered locally

CHARLOTTE, N.C. — Off Tuckaseegee road to the right of a Wendy’s, you’ll find StarMed Family and Urgent Care. There’s a tent outside for COVID-19 screening with results promised in five minutes

But the finger-prick tests this clinic is administering are not FDA approved. StarMed even said so on their website. The website promises the results in five minutes.

In a news release Friday night, Mecklenburg County warned about non-FDA approval rapid COVID-19 tests.

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“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.”

Mecklenburg County didn’t call out the clinic directly in the news release. Multiple sources confirmed to Channel 9 that the news release was about StarMed in west Charlotte. The type of tests StarMed is offering are the same ones the county said are potentially flawed.

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

StarMed released a statement Saturday in response to Mecklenburg County’s warning about their “potentially flawed” tests. Read the full statement here.

In an interview with WSOC, County Medical Director Dr. Meg Sullivan said there are a couple of issues with these rapid non-FDA approved tests.

Sullivan said the test may not be very sensitive meaning it might not be able to pick up COVID-19 early on, resulting in a false negative. If it produces a positive test, even that may not mean someone has COVID-19 because the test isn’t specific to this strain of coronavirus.

"There are some tests that have gone through a lot more scrutiny that are FDA approved that have been validated," she said. "Whereas others that are not FDA approved or just haven't had that scrutiny may provide that false sense of security."

Whatever the results say, the North Carolina Department of Health and Human Services isn’t accepting them since the test isn’t FDA approved.

“For a non-FDA test, that is not a reportable infection and I don’t want people to think they are now safe from getting COVID-19 again,” Sullivan said.

StarMed Chief Medical Officer Dr. Arin Piramzadian said he has confidence in the tests and would take one himself. When questioned why people should trust the test given it hasn’t been approved by the FDA, Piramzadian referenced a China study that involved less than 100 samples.

“We tell every patient that each test could be positive or negative,” Piramzadian said. “We have given them all discharge instructions. At no point are we telling anyone that they are allowed to go out and spread anything.”

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Piramzadian provided the discharge instructions to Channel 9. They state in all caps, “TESTING NEGATIVE DOES NOT MEAN YOU ARE ALLOWED TO GO OUT AND IGNORE CURRENT CURFEWS OR STAY AT HOME ORDERS.”

The instructions also warn the test can be negative early on even if they are infected and the patient should remain home for 14 days.

The tests offered by Piramzadian are $50 and will continue until FDA approved tests that he ordered arrive next week. He said it was always part of the plan to switch to them.

StarMed’s disclaimer on their website about their COVID-19 test:

Disclaimer:

If we suspect you have a false negative or are considered high risk we will send off your specimen to our lab. Considering that serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

This test has not been reviewed by the FDA.

Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.