First At-Home COVID Testing Kit Approved By FDA
The FDA granted emergency-use authorization for Lucira Health's nasal swab test for people over 14. The kit provides results within 30 minutes on the self-collected sample.
Reuters:
FDA Approves First COVID-19 Test Kit For Home Use
The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes. The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their health care provider, the FDA said. (11/17)
The New York Times:
F.D.A. Authorizes The First At-Home Coronavirus Test
A handful of other tests have been cleared by the F.D.A. for at-home collection of samples, which are then shipped to a lab for processing. But Lucira’s test is the first to remove the need for an intermediary. (11/18)
CNN:
FDA Authorizes First Rapid Covid-19 Self-Testing Kit For At-Home Diagnosis
The new test, which uses self-collected nasal swab samples, is authorized for people 14 and older with suspected Covid-19 and people under 13 when performed by a health care provider.
It is also authorized for use in point-of-care settings, such as doctor's offices, hospitals, urgent care centers and emergency rooms for all ages but must be collected by a health care provider, the FDA said. (Erdman, 11/18)
AP:
FDA Allows 1st Rapid Virus Test That Gives Results At Home
The Lucira COVID-19 test grew out of research the company was doing to develop an at-home flu test, according to the company’s website. Lucira adapted its technology to detect COVID-19 after the outbreak. The test uses technology similar to genetic laboratory-based tests that are the standard tool for COVID-19 screening. That’s different than most rapid tests currently used in the U.S., which look for viral proteins called antigens — not the virus itself. (Perrone, 11/18)
In other FDA EUA news —
Stat:
FDA Vows To Disclose Data Used To Support Emergency Authorizations
In response to blistering criticism, the Food and Drug Administration committed to publicly disclosing reviews of scientific data and other information that are used to authorize, revise or revoke emergency use of a medicine. The announcement came the same day that the U.S. Government Accountability Office issued a report noting the agency has failed to “uniformly disclose its scientific review of safety and effectiveness data” for emergency use authorization as it does for medicines undergoing the normal review process. (Silverman, 11/17)
