The Food and Drug Administration (FDA) in the United States, its drug regulatory authority, has permitted the commercialization of a rapid COVID-19 at-home testing kit for individual use. It is now possible in the US to avail of testing since the 17th of November.
1st Rapid At-Home COVID-19 Self-Testing Kit
The FDA has granted an emergency use authorization for the COVID-19 diagnostic test of Lucira Health.
The molecular, single-use Lucira COVID-19 All-In-One Test Kit has the possible capacity of detecting the coronavirus in an individual.
The testing kit, which is permitted for mere prescription use, uses nasal swab detection. The results are shown on the unit's light-up display and would indicate either positive or negative, reported an FDA press release.
According to the company's website, the COVID-19 kit is expected to cost $50 or under.
"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home," reported FDA Commissioner Stephen Hahn in a statement.
For 14 years and older individuals, the Lucira COVID-19 All-In-One Test Kit is the first FDA EUA authorized prescription home testing.
The diagnostic has also been authorized for utilization in point-of-care settings. These settings include doctor's offices, hospitals, emergency rooms, and urgent care centers. Any person wishing to receive the home rapid COVID-19 test should have a prescription.
Individuals under 13 may use the testing kit when performed by a health care provider.
"This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission," added Hahn, reported KPEL.
The new medical kit consists of a sample vial, a sterile swab, batteries, a test unit, and a plastic disposal bag.
This underscores the FDA's commitment underway in order to expand access to testing for COVID-19.
The testing requires placing the swab into a vial that is put in a test unit and after 30 minutes or less, the results are indicated directly from the unit's light-up display reading if an individual tests positive or negative.
The number of COVID-19 cases across the nation continues to increase prior to Thanksgiving. Google is reporting the word "testing" has been mostly looked up on its search bar.
According to officials, people who test positive using the medical kit must self-isolate and receive additional care from their health care provider.
Experts remark that home testing kits could be game-changers as they are more convenient for use to detect if a person is contagious.
Individuals who test negative but still exhibit the respiratory illness' symptoms should follow up with their health care provider. Negative results do not prevent a person from contracting the virus, according to authorities.
According to said Dr. Jeff Shuren, Director of the FDA's Center for Devices and Radiological Health, "A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic," reported Yahoo News.