"The FDA continues to demonstrate its unprecedented speed in response to the pandemic", FDA Commissioner Dr. Stephen Hahn said.
While the Lucira test provides results on the spot, it still isn't the kind of cheap and rapid antigen test that some researchers have called to use for large-scale population screening.
The single-use test, made by Lucira Health, has been given emergency use authorisation for home use with self-collected nasal swab samples in individuals aged 14 and above, the U.S. body said in an official statement.
After using the nasal swab, the test works by swirling the sample in a vial and then placing it in the provided test unit, according to the FDA.
Lucira's COVID-19 testing kit was compared with one of the most reliable FDA authorized high sensitivity SARSCoV-2 assays available.
The FDA issued an emergency use authorization Tuesday for the first self-testing COVID-19 kit to use at home, which provides results in about 30 minutes. It has also been authorized for use by healthcare professionals in minors under the age of 14. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. "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 tech has been developed by California's Lucira Health: which was founded in 2013 and has been working on a rapid identification kit for flu for five years. Those who test negative but have COVID-like symptoms should follow up with their doctor, since a negative result doesn't necessarily mean they don't have the coronavirus. Most of those include nasal swab tests performed by healthcare experts and for the results, the samples need to go to laboratories.
"However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests", Engelson said. Samples must be collected by a health care provider, though, when the test is used at a POC to test individuals younger than 14 years old, the FDA said.
According to Lucira Health, the tests have a sensitivity of about 94.1 percent and a specificity of 98 percent.