The US Food and Drug Administration (FDA) granted emergency use authorization November 17 for the first at-home self-test that the administration says provides results in 30 minutes or less. The single-use test, known as the Lucira COVID-19 All-In-One Test Kit, collects nasal swab samples in individuals age 14 years and older whose healthcare provider suspects a SARS-CoV-2 infection.
Currently the test is authorized for prescription use only.
How it Works
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit, according to a news release from the FDA. 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.
“…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.”
FDA Commissioner Stephen M. Hahn, MD
Vaccine Authorization Expected in Days
In an update about Operation Warp Speed, Health and Human Services Secretary Alex Azar announced Wednesday, November 18, that pharmaceutical companies Pfizer and Moderna were expected to have 40 million does of COVID-19 vaccine ready by the end of 2020.
During the briefing Azar noted that both companies could have their vaccines ready for authorization and distribution in the United States within weeks, according to a report published in the Daily Mail.
The first shots will be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.
An expert panel advising the CDC is meeting next week to determine the order of priority for vaccines distribution.
[Sources: US Food and Drug Administration, Daily Mail]