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  6. At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
  1. Coronavirus (COVID-19) and Medical Devices

At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions

Diagnostic tests can show if you have an active COVID-19 infection and need to take steps to quarantine or isolate yourself from others. 

This page is part of the FAQs on Testing for SARS-CoV-2 and provides answers to frequently asked questions related to at-home COVID-19 diagnostic tests. 

Q: Can I use an authorized at-home COVID-19 diagnostic test if it was left outside in freezing temperatures? (1/22/22)

A: Since shipping conditions may vary, test developers perform stability testing to ensure that the test performance will remain stable when tests are stored at various temperatures, including shipping during the summer in very hot regions and in the winter in very cold regions.

However, test performance may be impacted if the test is used while it is still cold, such as being used outdoors in freezing temperatures or being used immediately after being brought inside from freezing temperatures. The stated performance generally assumes the test is being performed in an environment that is between 15-30⁰C (approximately 59-86⁰F). The specific conditions that were validated are included in the authorized Instructions for Use for each test.

In order to ensure appropriate test performance with a test that is delivered to you in below freezing temperatures, you should bring the package inside your home and leave it unopened at room temperature for at least two hours before opening it. Once the package is at room temperature, you may open it and perform the test according to the authorized instructions for use. As long as the test line(s) appear as described in the instructions, you can be confident that the test is performing as it should. If the line(s) do not appear in the correct location(s) and within the correct time as shown in the test instructions when you perform the test, then the results may not be accurate, and a new test is needed to get an accurate result.

Q. Are at-home COVID-19 tests safe to use? Do they contain toxic chemicals? (3/18/22) 

A: FDA authorized at-home COVID-19 tests are safe to use when people follow the manufacturer’s step by step instructions. However, incorrect use of at-home COVID-19 tests can cause harm if the parts of the test kit, such as liquid solutions in small vials that may contain chemicals like sodium azide, are swallowed or if the liquid solutions touch a person’s skin or eyes.  The FDA has provided recommendations to promote the safe use of at-home COVID-19 tests in a Safety Communication issued March 18, 2022, including to keep all parts of at-home COVID-19 tests out of reach of children and pets before and after use, and to follow the test’s step by step instructions exactly, including the Warning, Precautions, And Safety Information.  

Q. Can I use an FDA-authorized at-home COVID-19 diagnostic test that is expired? (3/18/22) 

A: No, the FDA does not recommend using at-home COVID-19 diagnostic tests beyond their authorized expiration dates. COVID-19 tests and parts they are made of may degrade, or break down, over time.  Because of this, expired test kits could give inaccurate test results.  

COVID-19 test manufacturers perform studies to show how long after manufacturing COVID-19 tests perform as accurately as the day the test was manufactured. Since it takes time for test manufacturers to perform stability testing, the FDA typically authorizes at-home COVID-19 tests with an expiration date of about four to six months from the day the test was manufactured, based on initial study results.  Once the test manufacturer has more stability testing results, such as 12 or 18 months, the test manufacturer can contact the FDA to request that the FDA authorize a longer expiration date.  When a longer expiration date is authorized, the test manufacturer may send a notice to customers to provide the new authorized expiration date, so the customers know how long they can use the tests they already have.  

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