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While there are a few at-home testing kits on the market, Lucira Health’s is the first to offer rapid results — and it received Federal Drug Administration (FDA) authorization on November 17, 2020. The nasal swab test is prescription-only, and Northern Californian residents will have access to it first.
Lucira’s test requires you to collect a nasal sample by rotating a swab five times in each nostril. Once you’ve swabbed your nose, swirl the swab in a vial and place it in a battery-powered test unit. When the results are ready, they’ll appear on the unit’s light-up display.
The all-in-one test kit produces a positive COVID-19 result in 11 minutes and a negative result in 30 minutes. To get the most accurate reading, wait the full half-hour.
No. The kit is designed to be single-use, so you’ll need to purchase a new one if you want to take another test.
No. The FDA gave the Lucira Health all-in-one test kit an emergency use authorization (EUA) so people can access it during the pandemic. Once the national health emergency is over, the test will go through FDA approval, a rigorous process that can take anywhere from a few months to a few years.
As of January 25, 2021, the FDA has authorized a handful of nasal swab and saliva tests for at-home use — though none but Lucira Health’s provide rapid results.
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According to Lucira Health, the test has a 94.1% accuracy rate for positive results — a number based on the hundred-plus patients who participated in the clinical trial to get FDA emergency authorization. For negative results, it’s a little higher at 98%.
However, the FDA says negative results “don’t preclude an individual from SARS-CoV-2 infection.”
As for ease of use, 100% of people 14 and older were able to successfully administer the test.
The test is authorized for prescription use only, so you may be able to get it if your doctor suspects you have COVID-19. Those 14 years old and above can test themselves at home, while anyone 13 and under needs to have their sample collected by a healthcare provider at a doctor’s office, hospital, urgent care center or emergency room.
Nowhere yet — the test kit is still in production and set to launch in the next few months.
Once the test kit is released, Sutter Health will distribute Lucira Health’s test kit through its 24 hospitals and 200 clinics in Northern California, according to ABC7. It will be available in the Bay Area first, before rolling out to the rest of the state.
The company says the test will be administered in Florida’s Miami-Fort Lauderdale region next and should be available nationwide in spring 2021.
It’s not for individual sale. You’ll need to get a prescription from a healthcare provider, and kits are limited to those exhibiting COVID-19 symptoms.
In the meantime, you can sign up for Lucira Health’s email list to receive a notification when the test kit becomes available.
The Lucira Health at-home test kit will cost approximately $50, according to the ABC7 interview.
We’re still confirming this detail with the company. But technically, all COVID-19 tests should be covered by health insurance under the CARES Act — you just may need to file a claim on your own.
Formerly known as Diassess, Lucira Health develops single-use, portable test kits that are intended to stop the spread of infectious diseases. It originally created the self-testing kit to diagnose the flu but modified it at the onset of the pandemic to detect SARS-CoV-2 — the coronavirus strain that causes COVID-19.
The California-based company filed a $115 million IPO with the US Securities and Exchange Commission on January 19, 2021.
The Lucira Health COVID-19 all-in-one test kit is the first at-home test delivering rapid results. It requires you to swab your nose and wait 11 to 30 minutes for a reading. But it hasn’t been released just yet, and it’ll be prescription-only.
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