NYSDA Publications

FDA Issues Guidance on Use of At-Home OTC COVID-19 Tests

Per the notice below, the United States Food and Drug Administration (FDA) has issued guidance on how to use at-home over-the-counter (OTC) novel coronavirus (COVID-19) tests.

Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results

The U.S. Food and Drug Administration (FDA) is providing an easy step-by-step guide to help you decide when and how many times to test for COVID-19, what your test results mean, and what you should do next.  FDA-authorized over-the-counter (OTC) at-home COVID-19 tests for self-testing at home or other locations are a fast and convenient COVID-19 testing option.  With the holiday season upon us and many indoor gatherings taking place, we hope this information will help guide you and your families through a safe and healthy holiday and beyond, especially with other respiratory infections circulating, including flu and RSV.  The new Web page, Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results, includes information about:

  • When and how many times you should test for COVID-19
  • What your at-home OTC COVID-19 test result means
  • What at-home COVID-19 tests do not tell you
  • A step-by-step guide on what to do if your test result is positive or negative for COVID-19
  • Link to a list of FDA-authorized at-home OTC COVID-19 diagnostic tests



For general questions about COVID-19 testing, contact the Division of Industry and Consumer Education.