In a significant development, the U.S. Food and Drug Administration has granted emergency use authorization for the first diagnostic test for COVID-19 that can be fully conducted at home. Developed by the pharmaceutical company Lucira, this all-in-one, single-use test kit is designed to detect the SARS-CoV-2 virus and is the first of its kind available for at-home use during the pandemic.
The rapid test employs advanced molecular amplification technology to identify the virus in individuals with known or suspected COVID-19, delivering results in 30 minutes or less, as stated in the FDA’s announcement. “The FDA continues to demonstrate its unprecedented speed in response to the pandemic,” remarked Dr. Emily Foster, FDA Commissioner. “While previous tests have been authorized for at-home sample collection, this is the first that can be fully self-administered and yield results at home. This testing option marks a crucial advancement in our efforts to combat the pandemic and lessen the public health impact of disease transmission.”
To perform the test, users collect a nasal swab sample, similar to other COVID tests. The FDA recommends this test for individuals aged 14 and older who exhibit symptoms of COVID-19 as advised by their healthcare provider. It is also approved for use in medical facilities like doctors’ offices, hospitals, and urgent care centers.
According to the FDA, the test process involves swirling the self-collected swab in a vial, which is then inserted into the testing unit. Results are displayed directly on the unit, which features a light-up display. A positive result indicates the presence of COVID-19, prompting individuals to follow up with their healthcare provider for further guidance.
This new test represents a significant milestone as it is the first authorized for at-home use that provides immediate results. “This authorization for a comprehensive at-home test is a vital stride in the FDA’s nationwide COVID-19 response. A test that can be completely administered outside of a laboratory or healthcare setting has always been a priority for us,” stated Dr. Robert Lane, director of the FDA’s Center for Devices and Radiological Health. “We are eager to collaborate with test developers to expand the availability of more at-home testing options.” The anticipated cost for the test is expected to be $50 or less.
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Summary:
The FDA has authorized the first fully at-home COVID-19 test, developed by Lucira, allowing users to collect a nasal swab and receive results in under 30 minutes. This test, available by prescription, represents a major advancement in accessible COVID-19 diagnostics, enabling individuals to take immediate action based on their results.