The Food and Drug Administration (FDA) has issued a safety communication regarding the potential for harm if FDA authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions.
At-home COVID-19 test kits typically include test cartridges, nasal swabs, and small plastic vials with liquid solution that may contain chemicals such as sodium azide. The incorrect use of these tests may cause harm if, for instance, the liquid solution comes in contact with the skin, nose, mouth, or eyes, or if it is swallowed.
To ensure the safe use of at-home COVID-19 tests, the FDA has provided the following recommendations:
- 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.
- 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.
Reports of injuries due to incorrect use of at-home COVID-19 tests have included (1) instilling the liquid test solution into the eyes when small vials of test solution were mistaken for eye drops; (2) placing nasal collection swabs into the liquid solution prior to swabbing the nose; and (3) children putting test parts in their mouth and swallowing liquid test solution.
Issues related to COVID-19 testing should be reported to the FDA’s MedWatch Voluntary Reporting program.
Use and store at-home COVID-19 tests properly to avoid potential harm: FDA safety communication. News release. US Food and Drug Administration. Accessed March 23, 2022. https://www.fda.gov/medical-devices/safety-communications/use-and-store-home-covid-19-tests-properly-avoid-potential-harm-fda-safety-communication