The company developed the kit to diagnose flu but was able to modify it for COVID-19 in a matter of months.
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The palm-sized test kit produces results in 30 minutes or less. The optimum time to test, according to Lucira Health, is a couple of days after symptoms develop.
Los Gatos, California family practice Dr. Neeraj Kochhar was the principal investigator. He explained the timing.
"Because we're testing for the virus within the nose itself, and if it's too early in the incubation period, you can have negative results when patients do have virus, just not enough quantity," Dr. Kochhar said.
The mucus sample on the swab then goes into a vial with a reagent that starts the diagnostic process. A positive COVID-19 result takes 11 minutes while a negative result takes longer - 30 minutes.
More than a hundred patients participated in the clinical trial to obtain FDA emergency authorization with a 94.1% accuracy rate.
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Patients, especially children, found the Lucira device less invasive because the swab is inserted only about an inch to an inch and a half. The swab is rotated five times in each nostril. This differs from the nasopharyngeal tests done in the field.
"The original swabs had to be high because we were looking for actual genetic material from the virus itself and the antigen," explained Dr. Kochhar. "This is a molecular-based test, and so it's much easier for us to do it from a shallow swab."
The COVID-19 "All-in-One Test Kit" will be available soon through Sutter Health in the Bay Area for about $50. The unit is single-use.
Lucira says it can be disposed in the trash and hopes home testing will address concerns about transmission of symptomatic patients.
"This is going to be a giant step forward for them because this negates the need for them to have to go outside and therefore expose other people, particularly if they're feeling unwell," said Dr. Kochhar.