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 approaching 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 provided data showing that the shelf life is longer than was known when the test was first authorized,” 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 on how to administer each test) for three dozen manufacturers.
The FDA has specified that COVID-19 test manufacturers conduct studies to show how long after manufacturing they work as accurately as the day they were manufactured. Shelf life is the length of time the test should perform as expected and is measured from the date of manufacture of the test. The expiration date is set at the end of life and is the date until which the test is expected to perform as accurately as when it was manufactured.
Tests to determine this time period are called stability tests because they confirm the period of time over which performance is expected to remain stable.
There are different types of stability tests. The most accurate is real-time stability testing, where the manufacturer stores the tests for the proposed shelf life (plus a little extra time to ensure the expiration date can be trusted) and then evaluates their ability to function accurately. For example, for a proposed shelf life of 12 months, the manufacturer would evaluate 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 assurance as real-time data, especially over longer periods of time.
Based on experience with testing and stability testing, accelerated testing typically provides sufficient security to label tests with a shelf life of up to six months.
Because test manufacturers take time to perform stability testing, the FDA generally authorizes at-home COVID-19 tests with a shelf life of approximately four to six months from the day the test was manufactured, depending on initial test results. study, 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 at-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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