A coronavirus at-home testing kit from Lucira that offers results in 30 minutes is the first-ever approved by the FDA, which issued an emergency use authorization. It works via self-administered nasal swab which is then placed in the test unit.
CNBC reports: “Produced by a privately held, California-based biotech company, Lucira Health, the kit is also eligible for use in hospitals, though patients under 14 must have their sample collected by a health-care provider. The FDA did not reveal the price of the test. The company’s website says the test is ‘intended to cost less than $50.'”
Said FDA Commissioner Stephen M. Hahn: “The FDA continues to demonstrate its unprecedented speed in response to the pandemic. 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. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
“The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus,” the FDA continued. “Positive results indicate the presence of SARS-CoV-2. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.”