Mecklenburg Co. health officials say potential flaws in unapproved local rapid test outweighs convenience

Gibbie Harris, the county public health director, has banned large gathering and ordered the...
Gibbie Harris, the county public health director, has banned large gathering and ordered the closing of gyms, health clubs and theaters.(DAVID T. FOSTER III | Charlotte Observer)
Updated: Apr. 10, 2020 at 6:00 PM EDT
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CHARLOTTE, N.C. (WBTV) - Mecklenburg County health officials say that some rapid tests for coronavirus may give misleading results and provide to people who take the test 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,” says Mecklenburg 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 COVID-19.

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

Harris says residents who have symptoms of COVID-19 — fever, coughing and shortness of breath — should reach out to their healthcare provider or Mecklenburg County Public Health, and if they fit the criteria, be tested using methods approved by the FDA and accepted by the NC Division of Public Health and local hospitals.

StarMed Healthcare responded to the Mecklenburg County Health Department’s statement.

“I respect and understand why the Mecklenburg Health Department issued its statement,” said Dr. Arin Piramzadian, Chief Medical Officer at StarMed Healthcare. “They are not wrong. If clinics do this test without doing proper education while having the correct processes in place, there is an inherent risk of giving individuals false assurance and making the spread worse. However, that is not us. We do have the processes in place for testing and patient education. We welcome further constructive dialogue with the health department.”

StarMed Healthcare addressed several points for rapid antibody tests.

Those issues can be found here.

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