The US Food and Drug Administration (FDA) issued emergency use authorization for the Status COVID-19 Antigen Rapid Test for Home Use, manufactured by Princeton BioMeditech Corp, an over-the-counter COVID-19 antigen diagnostic test that shows results in 15 minutes.
The home COVID-19 test can be used for serial testing for people who have symptoms within the first five days of symptoms or for people who do not have symptoms.
The test should always be repeated if a negative result is found. Specifically:
- Test at least two times over three days with at least 48 hours between tests if the person has symptoms, or
- Test at least three times over five days with at least 48 hours between tests if the person does not have symptoms.
The test can be used for people:
- Age 14 years or older with a self-collected nasal swab sample.
- Age 2 years or older when an adult collects the nasal swab sample.
Validation data to support the emergency use authorization of this test was gathered through the National Institutes of Health Independent Test Assessment Program, established as a collaboration between the FDA and the NIH.
A list of all antigen diagnostic tests for SARS-CoV-2 that have been granted emergency use authorization from the FDA can be found here.