December 14, 2022
-
General Information About At-Home OTC COVID-19 Diagnostic Tests
This page has information about at-home over-the-counter (OTC) COVID-19 diagnostic tests. Diagnostic tests can show if you have an active COVID-19 infection.
These at-home OTC COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations). This means you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory.
There are two types of COVID-19 diagnostic tests, molecular and antigen, which detect different parts of the virus. Most authorized at-home OTC COVID-19 tests are antigen tests, and there are also a small number of authorized at-home OTC COVID-19 molecular tests.
When using a COVID-19 antigen diagnostic test, you should repeat testing following a negative result, whether you have symptoms or not, to reduce your risk of a false negative test result. For more information about this, read our FDA Safety Communication.
For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results.
Authorized at-home OTC tests are available without a prescription and are typically available online or at local stores. Testing and other protective steps like wearing a mask and COVID-19 vaccination are important to stop the spread of COVID-19 infection.
For more information, including answers to frequently asked general questions about at-home COVID-19 diagnostic tests, visit At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.
List of Authorized At-Home OTC COVID-19 Diagnostic Tests
The table below lists FDA-authorized at-home OTC COVID-19 diagnostic tests, and includes information on expiration dates, who can use the test, and other details that may help you decide what test is right for you. To see complete information on smaller screens, select the blue plus (+) button beside the test name.
The table includes links to home use instructions for each test. For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs.
In the table below, the “Expiration Date” column lists the shelf-life and where to find the expiration date for that test. The shelf-life is how long the test should work as expected and is measured from the date the test was manufactured. The expiration date is set at the end of the shelf-life. In some cases, the expiration date for a test may be extended. An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized. For more information about how the expiration date is determined and why it may be extended, see the At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.
To see if the expiration date for your at-home OTC COVID-19 test has been extended, first find the row in the below table that matches the manufacturer and test name shown on the box label of your test.
- If the Expiration Date column says that the shelf-life is “extended,” there is a link to “updated expiration dates” where you can find a list of the original expiration dates and the new expiration dates. Find the original expiration date on the box label of your test and then look for the new expiration date in the “updated expiration dates” table for your test.
- If the Expiration Date column does not say the shelf-life is extended, that means the expiration date on the box label of your test is still correct. The table will say “See box label” instead of having a link to updated expiration dates.
The FDA will update this table as additional shelf-life extensions are authorized.
To see complete information on smaller screens, select the blue plus (+) button beside the test name.
-
CLICK HERE to review the tests and expiration dates
Click to Subscribe for the MS Beacon eNewsletter and MS educational events
|
