Some at-home COVID-19 tests may miss the Omicron variant, FDA warns

Some at-home COVID-19 tests may fail to detect the Omicron variant, federal regulators and local health officials are warning.

Using data submitted by manufacturers, the U.S. Food and Drug Administration released preliminary guidance on rapid test platforms that could return false negatives when a person is infected with Omicron.

Dr. Rendi Murphree, an epidemiologist and director of disease surveillance with the Mobile County Health Department, told residents in a briefing that patients infected with Omicron may test false negative on certain test platforms. Health officials continue to recommend vaccination, masking and confirmed testing for anyone with symptoms or known exposure.

How the tests differ

Rapid at-home tests are antigen tests, which look for proteins from the virus, while laboratory PCR tests detect the virus’s genetic material and are generally more sensitive. In late December 2021, the FDA said early data suggested antigen tests do detect the Omicron variant but may have reduced sensitivity, and it advised people who test negative but have symptoms or a known exposure to consider repeat testing or a laboratory test.