FDA Now Recommends Taking Up to 3 At-Home COVID Tests to Confirm Negative Result

To reduce the risk that an infection may be missed, the U.S. Food and Drug Administration (FDA) is now recommending that individuals using coronavirus antigen tests take at least three tests, instead of the previously recommended two tests.

The agency issued the updated recommendations as children across the country prepare to return to school and the Centers for Disease Control and Prevention (CDC) eased guidelines for quarantining after exposure to COVID-19.

"The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others," the agency said in a press release. "The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms."

Here's a closer look at the new recommendations, what inspired them, and how the new guidance should be implemented.

Why Is an Additional Test Being Recommended at This Point?

At-home tests, which are primarily antigen tests, have always been a good way to detect for COVID-19, but they have never been as thorough as the more accurate molecular polymerase chain reaction (PCR) tests conducted in a lab. Molecular COVID-19 tests generally detect the COVID-19 virus at least 95% of the time when someone is infected. At-home COVID-19 antigen tests, on the other hand, generally detect the virus at least 80% of the time when someone is infected, according to the FDA.

"When you perform an at-home COVID-19 antigen test, and you get a positive result, the results are typically accurate," the FDA press release explains. "However, if you perform an at-home COVID-19 antigen test, you could get a false negative result. This means that the test may not detect the SARS-CoV-2 virus that is in your nasal swab sample. This could happen if you test soon after you get an infection, especially if you don't have COVID-19 symptoms. If you receive a false negative test result, you may unknowingly spread the SARS-CoV-2 virus to others."

The agency said its new recommendation is based on the latest study results from people with likely omicron infection showing that repeat testing after a negative at-home COVID-19 antigen test result increases the chance of an accurate result.

"COVID-19 antigen tests may not detect the SARS-CoV-2 virus early in an infection, meaning testing soon after you were exposed to someone with COVID-19 could lead to a false-negative result, especially if you don't have symptoms," the FDA said. "This is the reason why repeat testing is important."

How To Follow the New Guidelines

All at-home COVID-19 antigen tests are authorized for repeat or serial use. Individuals are being advised to use multiple tests over a certain period of time, such as two to three days. This approach is especially recommended for those who are not experiencing COVID-19 symptoms at the time of initial testing.

The agency is also recommending that individuals conduct repeat testing over a longer period of time.

"The FDA...is now asking that exposed individuals who are using at-home antigen tests to perform three tests on or after day five," Hannah Newman, MPH, FAPIC, director of infection prevention at Lenox Hill Hospital in New York. "This recommendation applies to all exposed individuals using at-home tests, regardless of whether or not they have symptoms or are asymptomatic."

The three tests, Newman says, should be spaced out at least 48 hours to reduce the risk of a false negative.

The FDA also pointed out that you do not need to use the same brand of test each time when repeat testing. The government agency's website provides a list of all FDA-authorized home tests as well as additional information about who can use a test and at what ages.

The recommendations also advise those who've had a negative COVID test at a doctor's office to follow-up with several at home tests.

"Be aware the FDA expects similar performance with Point of Care (POC) COVID-19 antigen tests performed at a clinic or doctor's office," the FDA explained in its new guidelines. "A negative POC COVID-19 antigen test result should also be followed up with repeat, or serial testing, and an at-home test could be used."

Is COVID-19 Still a Serious Threat?

COVID-19 has moved from pandemic to endemic. Endemic refers to a disease that is consistently present, but limited to a particular region. This means that COVID-19 is a virus that will not be going away and one that we have to learn to live with. Still, the goal should always be to help curb the spread, say experts.

"At the moment, we're not doing much to inhibit the spread of an extraordinarily contagious virus," William Schaffner, MD, professor of preventive medicine, health policy and a professor for the division of infectious diseases at Vanderbilt University Medical Center, told Health.

While hospitalizations have been on the decline, dropping 2.6% since this same time last week, the omicron variants that are circulating are extremely contagious.

The good news however, is that the variants are less serious. And that reality has caused other guidelines to shift recently, as well. The CDC just announced that unvaccinated people no longer have to quarantine at home after being exposed to someone with COVID-19. In making its announcement, the CDC explained that the updated recommendations were designed to streamline guidance and make it more "reflective of the current state of the pandemic," in which there are plenty of treatment and prevention options available, and the variant currently circulating typically does not cause as severe of illness.

"Previously those who were not up-to-date on vaccinations were recommended to practice social distancing by staying at least six feet away from others while indoors," said Newman. "Now, CDC advises that people may want to avoid crowded areas or maintain a distance from others in order to minimize risk of exposure, though without the specific six-feet prescription."