The US Food and Drug Administration (FDA) issued an emergency use authorization for the Azure Fastep COVID-19 Antigen Pen Home Test, manufactured by Azure Biotech, an over-the-counter COVID-19 antigen diagnostic test that shows results in 15 to 30 minutes.
The test can be used for serial testing for people who have symptoms within the first six days of symptoms or for people who do not have symptoms and undergo additional testing. 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 National Institutes of Health.
According to the FDA, the test should 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.
The FDA says the EUA issued for this test is the latest example of its ongoing commitment to maintaining access to long-term testing. “The FDA remains committed to ensuring the public has access to accurate and reliable COVID-19 tests,” according to a press release from the FDA.