Yes, you can use your expired COVID test kit — but first check with the FDA, manufacturer
Over 400 tests have been authorized for emergency use by the FDA, and not all are reliable beyond their expiration dates.
Lindsey Leake- FDA has extended shelf life of select at-home coronavirus tests
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- Up to 1 million expired Florida tests given extension
We’ve all done it: finished off a gallon of milk or loaf of bread after its expiration date. Waste not, want not, right?
Perhaps you’re even guilty of consuming medication or applying a beauty product that’s long past its prime.
But can you bend the rules when it comes to diagnostic COVID-19 testing?
It depends.
“If you do have an expired test, look it up to see whether it is one that has gotten approved to be extended,” said Cindy Prins, an epidemiologist at the University of Florida College of Public Health and Health Professions. “Don’t just assume that every test has been extended.”
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Demand for testing has soared in the new year, as the omicron variant of SARS-CoV-2 rapidly spreads across the country. A recent spat between Florida politicians has thrust the shelf life of over-the-counter (OTC) tests into the spotlight.
The Department of Health stockpiled “a significant number” of tests on the verge of expiration, Commissioner Nikki Fried, the Democratic head of the Department of Agriculture and Consumer Services, said in a Dec. 30 tweet. She asked Gov. Ron DeSantis, her Republican gubernatorial opponent in the November election, to release the tests to local governments and launch state-run testing sites.
“To let them expire is negligent, or heartless,” Fried said.
The 800,000 to 1 million BinaxNOW COVID-19 Self Tests, manufactured by Abbott, already had expired — twice. They expired in September, were given a three-month extension, then expired again in December, Kevin Guthrie, the Division of Emergency Management director, confirmed in a Jan. 6 news conference in West Palm Beach.
The kits were saved Jan. 7, when the U.S. Food and Drug Administration granted Abbott’s request to extend their shelf life to 15 months at room temperature.
You wouldn’t know that, though, without scouring the FDA website. The extension hadn’t been conspicuously posted on the Abbott site as of Jan. 18; per its FAQs, “each product box has an expiration date and should not be used after that date.”
Scroll down for a step-by-step guide to searching the FDA diagnostic testing database.
How can I tell if my COVID test has expired?
It’s hard to keep up with the world of coronavirus testing. As of Jan. 18, the FDA had authorized 420 tests and sample collection devices for emergency use, and issued 766 revisions to these authorizations. However, just 16 are at-home, OTC tests.
The simplest way to check if your test is valid is to look for the expiration date on the packaging. Some tests, such as Siemens’ CLINITEST, feature the date on both the box and test pouches.
If your test has expired, read the fine print in the instruction manual. It likely will say, perhaps in bold, underlined font, not to use the kit.
Don’t panic yet.
As the tests are relatively new — no OTC rapid test currently authorized by the FDA is older than 13 months — “they had, probably, a pretty conservative expiration date at first,” Prins said. “Companies continue to test them … and validate them for longer periods of time.”
The swabs don’t go bad, she said, adding that the accompanying liquid, called the reagent, typically is a salt solution called sodium azide.
“Most salt solutions are pretty stable at room temperature,” Prins said. “It’s not something that you would worry about going bad very quickly.”
Even so, the two kinds of diagnostic tests can become less sensitive to the presence of the virus over time.
What’s the difference between PCR and rapid COVID tests?
Rapid tests, which usually give a result within 10-20 minutes, also are called antigen tests, meaning they detect SARS-CoV-2 proteins.
Molecular tests, often referred to as PCR (polymerase chain reaction) tests, identify the virus’ genetic material. They may involve at-home sample collection, but typically must be processed by a certified clinical laboratory. It may take several days to get a result.
The FDA had granted emergency use authorization to 13 at-home, OTC antigen tests and three such molecular tests as of Jan. 18.
Molecular tests tend to be more expensive. At CVS Pharmacy, for example, the Pixel by Labcorp COVID-19 PCR Test Home Collection Kit is $124.99 online. The Flowflex COVID-19 Antigen Home Test is $9.99.
There’s a trade-off to the price and convenience of antigen tests. They’re less sensitive, so if you test negative, that doesn’t necessarily mean you don’t have COVID-19.
“Ideally, you should get PCR,” said Dr. Kami Kim, director of the Division of Infectious Disease and International Medicine at the University of South Florida Morsani College of Medicine. “Because you need to make some decisions about isolation and exposure … if you’re symptomatic, you should probably just get whatever test you can.”
Antigen tests, though, have a leg up in terms of shelf life, Kim explained.
“The RNA used for the PCR test is pretty notoriously unstable,” she said. “That’s why it usually has to be in a lab setting, and it’s really hard to stick in a kit.”
What should I do if my COVID test has expired?
If your test kit has expired and the instructions say not to use it, reach out to the manufacturer directly to inquire whether a shelf-life extension has been granted.
A notice may be posted on the company website. Some manufacturers, such as Ellume, have customer service hotlines and emails dedicated to testing concerns.
Lastly, consult FDA databases for the most comprehensive information:
- Visit fda.gov/medical-devices
- Within the blue box labeled “Coronavirus (COVID-19) and Medical Devices,” click “Learn More”
- Click “Emergency Use Authorizations (EUAs) for Medical Devices During COVID-19”
- Scroll down and click “In Vitro diagnostics EUAs”
- Depending which type of test you have, scroll down and click either:
- At the bottom of each page is a searchable table. Once you locate your test, click the blue plus-sign at left to view associated documents. Any revisions made to the test’s emergency use authorization will appear here.
For example, a Jan. 14 letter confirms the shelf life of the prescription-only INDICAID COVID-19 Rapid Antigen Test, manufactured by PHASE Scientific, has been extended to nine months at room temperature. If you’re within nine months of the manufacturing date on your test kit, you may use it regardless of the original expiration date.
If your test has long since expired without extension, toss it, said Prins, of UF. However, there is a way to assess your test’s validity regardless of age.
“One thing people may not be aware of is that these tests have a control line,” she said. “You want to make absolutely sure that that control line does go positive, because that’s the marker of whether the test is working the way it should.”
She added, “If that doesn’t go positive … it doesn’t mean that you got a negative result. It means that you got an inaccurate result.”
Lindsey Leake is TCPalm's health, welfare and social justice reporter. She has a master's in journalism and digital storytelling from American University, a bachelor's from Princeton and is a science writing graduate student at Johns Hopkins. Follow her on Twitter @NewsyLindsey, Facebook @LindseyMLeake and Instagram @newsylindsey. Call her at 772-529-5378 or email her at lindsey.leake@tcpalm.com.