Potential Flaws in Unapproved Local Rapid Test
4/10/2020
Mecklenburg County Public Health is warning residents that some rapid tests for COVID-19 may provide misleading results, giving 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 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," says Harris. "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.
"There is at least one non-FDA approved test being used in our community," says 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," says Harris. "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.
It is important to make sure the information you are getting about COVID-19 is coming directly from reliable sources like MCPH, CDC and NCDHHS. The best resource for information about COVID-19 in Mecklenburg County is the County’s COVID-19 website. Individuals can also call the County’s COVID-19 hotline at 980-314-9400. For more information, please visit the CDC’s website and NCDHHS’ website, which will also include future positive COVID-19 test results in North Carolina.
