At-home COVID-19 tests have become more readily available in recent months, and many people have boxes of unopened, unused tests around the house — perhaps free tests from the federal government through the U.S. Postal Service, tests covered by insurance or tests we purchased on your own.
Before you use those tests, though, you’ll want to check the expiration or use-by dates on the boxes — especially if you’ve been hanging on to the tests for more than a few months.
Yes, at-home COVID tests have expiration dates.
But does the date really mean anything? Could you still use the test after the date listed on the box? Would it affect the accuracy or reliability of your test results?
For answers to those questions and more, The News & Observer consulted information from the U.S. Food and Drug Administration (FDA), which authorizes at-home COVID tests for use.
Here’s what to know.
Why do at-home COVID tests have expiration dates?
At-home COVID tests are assigned expiration dates to give users a time frame in which they should use the test so that the test gives accurate, reliable results. After this date, the test could degrade and it is not guaranteed to give accurate results.
▪ The expiration date for tests is assigned by the FDA based on the shelf-life of the test, or “how long the test should perform as expected.” The expiration date for tests is the end of the test’s shelf-life, or the point at which the test is no longer expected to perform as accurately as it did when the test was first manufactured.
▪ To determine the shelf-life of an at-home COVID test, manufacturers perform stability testing. This testing confirms the time period over which the test’s performance and subsequent results remain stable, accurate and reliable.
▪ The FDA typically authorizes new at-home COVID tests — that’s each kind of test, made a given brand or manufacturer, not each individual test distributed to users — with a shelf-life of about four to six months, meaning the test’s expiration date is about four to six months after it is manufactured.
▪ As test manufacturers perform more stability testing on their products, allowing the test’s performance to be studied over a longer period of time, the FDA may extend the shelf-life and expiration dates of those tests, giving users more time to use the tests than what was originally recommended.
Can you use at-home COVID tests after the expiration date?
The FDA “does not recommend using at-home COVID-19 diagnostic tests beyond their authorized expiration dates.”
▪ That’s because the tests and the parts they are made of may degrade, or break down, over time, the FDA says. Thus, using expired tests “could give inaccurate or invalid test results.”
Where is the expiration date listed on at-home COVID tests?
The expiration date for at-home COVID-19 tests should be listed on the packaging, such as the box, that the test comes in.
▪ For example, on an iHealth brand test, the expiration — which is actually listed as a use-by date — is on the back of the box, next to a QR code and under other information about the test, such as the lot and serial numbers.
▪ The expiration date should list the month, day and year that the test is set to expire.
Note: The expiration date listed on your at-home test could be extended, allowing you to use it for longer — even up to months after the date printed on the test’s packaging, and the change may not be listed on your test.
▪ Expiration dates on tests may be extended by the FDA as more data is collected on the stability and shelf-life of each brand and specific kind of test.
For example, say a test was originally approved by the FDA with enough stability date to support a 6-month shelf-life. Then, months later, the company that made the test has enough data to prove that the test is shelf-stable for 12 months. The FDA could then extend the expiration date of all tests of that specific kind by that company.
How to tell if the expiration date of a COVID test was extended
Depending on when the tests you have were manufactured and packaged, the date on the packaging of your test may or may not be the most up-to-date expiration for the test.
▪ If the test was manufactured prior to the expiration date being extended for that specific kind of test, your test will likely have the original — or at least a previous — expiration date for that test, but you can use it up until the new expiration date. For example, if your test originally expired on June 1, but you find out that the expiration date was extended for six months, you would be able to use that test until December 1, even though the box still reads June 1.
▪ If the test was manufactured after the expiration date was extended for that specific test, your test should have the new expiration date listed and you should follow that date, unless an additional extension is issued.
▪ If you purchased your test directly from the manufacturer, the FDA says you should receive a notice from the manufacturer if the expiration of your test is extended, informing you about the new expiration date.
▪ If you did not purchase your test directly from the manufacturer — meaning you probably purchased it at a pharmacy, on Amazon or elsewhere — you likely will not receive a notice from the manufacturer about extended expiration dates.
The best way to check if the expiration date on your test’s packaging is up-to-date is to cross-check your test’s information with the FDA’s list of extended expiration dates.
Follow these steps to access the list and check your test’s expiration:
▪ Scroll down to the table of authorized tests.
▪ Find the brand and specific name of your test in the chart.
▪ Look under the “Expiration Date” column on the far right side.
▪ If the Expiration Date column says that the shelf-life of your test has been extended, there should be a link to “updated expiration dates.” Click the link, then compare the information on your test — likely the lot number or expiration date — to the information in the document provided to determine the new expiration date of your test.
▪ If the Expiration Date column does not say that the shelf-life of your test has been extended, the expiration date on your test’s packaging is still correct. You should follow that date and use your test within the time given.
The FDA will update the table and the information included as extended expiration dates are issued. Try bookmarking it and referring back to it periodically to see if your test’s expiration has been extended.
Additional information about expired COVID-19 tests
For more information on the shelf-life and expiration dates of at-home COVID tests, visit fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions.