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- General Information About At-Home OTC COVID-19 Diagnostic Tests
- Authorized At-Home OTC COVID-19 Diagnostic Tests and Expiration Dates
- Related Information
General Information About At-Home OTC COVID-19 Diagnostic Tests
At-home over-the-counter (OTC) COVID-19 diagnostic tests can show if you have an active COVID-19 infection.
Bạn đang xem: U.S. Food and Drug Administration
These at-home OTC COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations) without a prescription. Tests are available online or at local stores and you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory.
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With most at-home OTC COVID-19 diagnostic tests, you should repeat testing following a negative result, whether you have symptoms or not, to reduce your risk of a false negative test result. The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can send your test result to MakeMyTestCount.org or use an app or other digital option for self-reporting that may be included with your test. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results.
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.
Authorized At-Home OTC COVID-19 Diagnostic Tests and Expiration Dates
The table below is updated regularly and lists FDA-authorized at-home OTC COVID-19 diagnostic tests, including information on expiration dates, who can use the test, links to home use instructions for each test, and other details that may help you decide what test is right for you. For additional information about each Emergency Use Authorization (EUA), see In Vitro Diagnostics EUAs: Tables of IVD EUAs.
In the table below, the “Expiration Date” column lists where to find the expiration date for that test, and the “Other Details” column lists the shelf-life for the 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 and is the date through which the test is expected to perform as accurately as when manufactured. In some cases, the expiration date for a test may be extended.
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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 has been extended, then the Expiration Date column states “Extended Expiration Date” and links to a document that lists the lot numbers, original expiration dates, and the extended expiration dates. If your lot number and/or original expiration date do not appear, or if the Expiration Date column states “Expiration Date: See box label,” do not use the test beyond the original expiration date on your test.
Search the table below by manufacturer, test name, or other details shown in the table to find more information on the test, including if the expiration date has been extended.
To see complete information on smaller screens, select the blue plus (+) button beside the test name.
Related Information:
- COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
- Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
- At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
- COVID-19 Test Basics: Includes details on COVID-19 tests, types of samples, and other information.
- At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication
- Counterfeit At-Home OTC COVID-19 Diagnostic Tests
- Find COVID-19 Tests at COVID.gov/tests
- Video: How to Interpret Self-Test Results | CDC
- COVID-19 Testing: What You Need to Know | CDC
- COVID-19 Self-Testing At-Home or Anywhere | CDC
- What to Do If You Were Exposed to COVID-19 | CDC
- Isolation and Precautions for People with COVID-19 | CDC
- Video: What Is an EUA? Describes how the FDA can issue an emergency use authorization (EUA) to provide more timely access to diagnostic tests that may help during the public health emergency when there is no adequate, approved, and available alternative.
- 1The Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, is previously known as the COVID-19 At-Home Test. As the manufacturer, SD Biosensor, transitions to this new brand, customers may receive a product with the previously authorized COVID-19 At-Home Test labeling.
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