Date Issued: March 18, 2022
The U.S. Food and Drug Administration (FDA) is alerting people that there is a potential for harm if FDA authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions. The FDA is also reminding people to keep the tests out of reach from children and pets.
FDA authorized at-home COVID-19 tests have become an important and convenient tool that people can use to check if they or a family member are currently infected with SARS-CoV-2, the virus that causes COVID-19. FDA authorized at-home COVID-19 tests are safe to use when following the test’s step-by-step instructions.
However, incorrect use of FDA authorized at-home COVID-19 tests can cause harm if, for example, the liquid solutions in the test touch a person’s skin or eyes or if the parts of the test such as small vials containing the liquid solutions are swallowed. The liquid solution in some tests may contain chemicals like sodium azide, which may cause harm if swallowed or if it comes in contact with skin, nose, mouth, or eyes. The FDA is providing recommendations to promote the safe use of at-home COVID-19 tests.
- Keep all parts of at-home COVID-19 test kits out of reach from children and pets before and after use.
- Store the at-home COVID-19 test in its box until you are ready to use it.
- Follow the manufacturer’s step by step test instructions exactly.
- Read the Warning, Precautions, And Safety Information in the test instructions for a description of chemical ingredients and recommendations for safe handling and what to do if they accidentally touch your skin or eyes.
- Keep the liquid solution away from the skin, nose, mouth, and eyes. Do not swallow the liquid solution.
- Use only the swab in the test kit to collect a nasal sample.
- After you perform the test:
- Follow all test instructions for how to throw away the used test parts.
- Wash your hands thoroughly with soap and water.
Get medical help right away by contacting your local poison control or health care provider if:
- Skin or eye irritation does not go away after exposure.
- A person or animal swallows the liquid solution.
Avoid Potential Harm from Incorrect Use of At-Home COVID-19 Tests
At-home COVID-19 diagnostic test kits include different parts such as a test cartridge, nasal swab, and small plastic vials containing liquid solutions needed to perform the test. The liquid solutions may include chemical ingredients, such as sodium azide, that help the test work properly or act as preservatives. The test chemicals can be irritating or toxic if they get on your skin, nose, or eyes or if they are swallowed.
The FDA has received reports of injuries caused by incorrect use of at-home COVID-19 tests, including:
- Injuries caused by people accidently putting liquid test solution in their eyes when small vials of test solution were mistaken for eye drops.
- Injuries caused by placing nasal collection swabs into the liquid solution prior to swabbing the nose (the liquid solution is not supposed to touch your body).
- Injuries caused by children putting test parts in their mouth and swallowing liquid test solution.
Prior to authorization of an at-home COVID-19 test, the FDA reviews information about the test, including all parts of the test kit and all chemical solutions, to determine if they are appropriately safe for people to use and if any special instructions or equipment are needed to safely handle them, such as using gloves. Sometimes the FDA decides that certain tests are not safe for at-home use, such as when there is a chemical that is too toxic. In these cases, the FDA does not authorize those tests for home use.
The FDA will continue to closely monitor safety issues around at-home COVID-19 tests and is committed to protecting public health and assuring the safe use of these tests. The FDA will keep the public informed if significant new information becomes available.
Reporting Problems with Your COVID-19 Test
If you think you had a problem with your COVID-19 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100. You may also contact the customer service department for the COVID-19 test you are using.