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FDA Approves Fast and Convenient Azure Fastep COVID-19 Antigen Pen Home Test for Symptomatic and Asymptomatic Individuals
The FDA has approved the Azure Fastep COVID-19 Antigen Pen Home Test, a quick and convenient option for serial testing for symptomatic and asymptomatic individuals.
The FDA has issued emergency use authorization for the Azure Fastep COVID-19 Antigen Pen Home Test, manufactured by Azure Biotech, Inc. Validation data for this test was gathered through the National Institutes of Health Independent Test Assessment Program, a collaboration between the FDA and the NIH.
This test is specifically designed for serial testing for symptomatic individuals within the first 6 days of symptom onset or for people without symptoms. The results are available in just 15 minutes, making it a quick and convenient option for those seeking testing.
It is important to note that if a negative result is found, the test should always be repeated at least 2 times over 3 days with at least 48 hours between tests if the person has symptoms. For those without symptoms, the test should be repeated at least 3 times over 5 days with at least 48 hours between tests.
The test is suitable for individuals aged 14 years or older who can self-collect a nasal swab sample. For younger individuals aged 2 years or older, an adult can collect the nasal swab sample.
This latest development in COVID-19 testing is a significant step forward in the fight against the pandemic. With its fast results and ease of use, the Azure Fastep COVID-19 Antigen Pen Home Test can help identify and isolate infected individuals quickly, ultimately helping to slow the spread of the virus.
If you are experiencing symptoms or think you may have been exposed to the virus, the Azure Fastep COVID-19 Antigen Pen Home Test may be a valuable tool in protecting yourself and others.
