RELATED: Want to get a COVID-19 test in time for the holidays? Here's what you need to know
The company developed the kit to diagnose flu but was able to modify it for COVID-19 in a matter of months.
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 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.
VIDEO: How would a California curfew work? Are they effective? UCSF doctor weighs in
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.
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.
Q&A: Pfizer weighs in on when, how many COVID-19 vaccine doses could be distributed throughout U.S.
"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 concern 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.
App users: For a better experience, click here to view the story in a new window
If you have a question or comment about the coronavirus pandemic, submit yours via the form below or here.
Get the latest news, information and videos about the novel coronavirus pandemic here
RELATED STORIES & VIDEOS:
- Map: CA counties that can, can't reopen under new rules
- COVID-19 risk calculator: The safest and most dangerous things to do this holiday season
- Updated number of COVID-19 deaths, cases in Bay Area
- COVID-19 Help: Comprehensive list of resources, information
- COVID-19 Diaries: Personal stories of Bay Area residents during pandemic
- California EDD: The most commonly asked questions we get about unemployment and PUA
- Health experts urge flu shots in effort to avoid 'twindemic'
- How to tell the difference between seasonal allergies and coronavirus symptoms
- Here's which mask is better to protect from COVID-19
- First COVID-19 vaccine volunteers in US describe experience as Bay Area launches vaccine trials
- Coronavirus origin: Where did COVID-19 come from?
- What is a COVID-19 genetic, antigen and antibody test?
- What will it take to get a COVID-19 vaccine and how will it be made?
- What does COVID-19 do to your body and why does it spread so easily?
- Here's how shelter in place, stay at home orders can slow spread of COVID-19
- Coronavirus Timeline: Tracking major moments of COVID-19 pandemic in San Francisco Bay Area
- Coronavirus Doctor's Note: Dr. Alok Patel gives his insight into COVID-19 pandemic