January 9, 2021

COVID-19 Mutations Impact Testing

As the COVID-19 pandemic continues, there have been reports of new viral mutations, resulting in more strains of the virus. The FDA recently alerted clinical laboratory staff and healthcare providers that genetic variants of COVID-19 may lead to false negative results in certain diagnostic tests, which could result in delayed treatment and/or increased risk of spreading COVID-19.

This alert applies to all molecular tests for COVID-19, but specifically identifies three molecular tests that received emergency use authorizations (EUAs) to test for COVID-19. These tests include:

  • Accula SARS-Cov-2 Test
  • TaqPath COVID-19 Combo Kit
  • Linea COVID-19 Assay Kit

The FDA continues to monitor the effects of different variants on authorized molecular tests for the detection of SARS-CoV-2 and will update clinical laboratory staff and health care providers accordingly.

Molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target. Negative test results should be considered in combination with clinical observations, patient history, and epidemiological information. Healthcare professionals who encounter patients that test negative but still display symptoms should consider retesting with a different test.

The FDA reminds clinical laboratory staff and healthcare providers about the risk of false negative results with all laboratory tests, including molecular tests.

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