With kids heading back to school and end-of-summer travel at near-record levels, involving lots of close contact, you may be wondering if it's time to pack a COVID-19 surge test kit, if you or a loved one has a fever, sore throat, or other symptoms.
If you do, be sure to check the expiration date. Many test kits distributed for free by the U.S. government or that continue to be available from other public agencies may be expired or nearing their expiration date.
The good news is that the Food and Drug Administration (FDA) has extended the expiration dates of several test kits from certain manufacturers.
“An extended expiration date means that the manufacturer has provided data showing that the shelf life is longer than was known when the test was first licensed,” according to the FDA.
The agency lists authorized home tests with information on whether the expiration date has been extended for certain manufacturers.
This includes information on expiration dates (as well as additional details, such as how to administer each test) for three dozen manufacturers.
The FDA has said that COVID-19 test manufacturers conduct studies to show how long after manufacturing they perform as accurately as the day they were made. The shelf life is the length of time the test should perform as expected and is measured from the date the test is manufactured. The expiration date is set at the end of the shelf life and is the date until which the test is expected to perform as accurately as when it was manufactured.
Testing to determine this time period is called stability testing because it confirms the period of time over which performance is expected to remain stable.
There are different types of stability testing. The most accurate is real-time stability testing, where the manufacturer stores the tests for the proposed shelf life period (plus some extra time to ensure the expiration date can be trusted) and then assesses their ability to perform accurately. For example, for a proposed shelf life of 12 months, the manufacturer would assess performance after storing the test for 13 months.
In some cases, accelerated testing provides a faster way to estimate the stability of a test's performance over time by storing the test for a shorter time at a higher temperature and then evaluating its ability to perform accurately.
However, since accelerated testing only estimates the stability of the test, it does not provide as much confidence as real-time data, especially over longer periods of time.
Based on experience with stability testing and testing, accelerated testing generally provides sufficient confidence to label tests with a shelf life of up to six months.
Because it takes time for test manufacturers to conduct stability testing, the FDA typically authorizes at-home COVID-19 tests with a shelf life of about four to six months from the day the test was manufactured, based on initial study results, and may be expanded later as additional data is collected.
You can check the Expiration Date column of the List of authorized over-the-counter COVID-19 home diagnostic tests to see if the expiration date of your over-the-counter at-home COVID-19 test has been extended and how to find a new expiration date.
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