FDA urges public to use multiple at-home COVID-19 tests to avoid false-negative results

The Centers for Disease Control and Prevention may have loosened up its COVID-19 guidelines this week—pulling back its advice on quarantines while saying the coronavirus is here and here to stay—but the FDA is still urging people to take extra precautions when it comes to at-home testing.

In a public safety message, the agency reiterated its recommendations that people double-check any negative rapid test result with repeated home screenings, and that following up could help reduce the risks of getting a false negative whether or not a person is showing signs of the disease.

“Currently, all at-home COVID-19 antigen tests are FDA-authorized for repeat, or serial use. This means people should use multiple tests over a certain time period such as 2-3 days especially when the people using the tests don't have COVID-19 symptoms,” the agency said.

The FDA said its missive was based on study findings tracking more than 7,300 patients during the height of the pandemic’s omicron surge, which showed that repeated swabbing and testing after an initial negative reading increased the diagnostic’s overall accuracy.

When it comes to home-based antigen tests, the agency said they are less precise than molecular lab diagnostics, but they generally identify the virus correctly at least 80% of the time. The FDA added that any positive results are typically accurate. 

However, the virus can evade detection during the earliest stages of an infection, and the agency urged people to consider the continued risks of unknowingly spreading the disease.

“If you plan to use at-home COVID-19 antigen tests, have several tests on hand so you can test more than once,” the agency said. “You do not need to use the same brand of test each time for repeat testing.”

The same goes for point-of-care antigen tests performed in clinics or doctor’s offices, the FDA said. These negative results should be followed up with additional screenings, which can be performed at home.

On Thursday, the CDC said it was “streamlining its COVID-19 guidance.” Though the virus continues to circulate around the world, the center said the widespread use of vaccines has helped the public be better prepared.

“We’re in a stronger place today as a nation, with more tools—like vaccination, boosters and treatments—to protect ourselves and our communities from severe illness from COVID-19,” Greta Massetti, chief of the CDC’s field epidemiology and prevention branch, said in a statement.

Now, the center recommends that if a person is exposed to someone with COVID-19, they wear a high-quality mask for 10 days and get tested on day 5, instead of quarantining. 

However, the CDC also said that people who are positive for COVID-19 should continue to isolate themselves from others, for at least five days, regardless of vaccination status. People should also isolate themselves if they are sick but do not yet have a positive COVID-19 test result. 

People can end their isolation if they test negative, the CDC said—the FDA just hopes you rely on more than one test.