The nation’s first Food and Drug Administration authorized home coronavirus test will cost about $50 and deliver results in 30 minutes or less.
But forget about the test if you want to know whether you have COVID-19 before visiting family for Thanksgiving or Christmas.
The Lucira COVID-19 All-In-One Test Kit will be limited to patients at Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Fort Lauderdale until next spring. And even then, you must have symptoms and a health provider’s referral to get the test.
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With the nation’s labs, doctors and urgent care centers routinely testing more than 1.5 million Americans each day, experts don’t expect the new test will make an immediate and meaningful difference for most Americans.
“I’m afraid in the near future, it’s not going to have a large impact,” said Dr. Patrick Godbey, president of the College of American Pathologists. “It’s not going to be distributed widely until the spring.”
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The FDA authorized the Lucira test for patients aged 14 and up who are suspected of having COVID-19. The molecular test takes up to 30 minutes but can deliver positive results in 11 minutes, according to Lucira.
The test kit comes with a device, vial and swab, and requires two AA batteries. A person rotates the swab in each nostril five times, stirs the swab in a vial and presses the sample into the device. The device displays a light with either positive or negative results when the test is done. Patients are asked to report results to the doctor or medical office that recommended the test.
Lucira validated the test by comparing performance to another FDA authorized test in a group of more than 100 people from a broad range of ages, ethnicities and education levels, the company said.
The test correctly identified the virus in 94.1% of samples detected by the unidentified comparative test. It correctly reported negative results in 98% of samples.
While the test will only available to patients of the health systems in Northern California and South Florida, Lucira, a startup company with 40 employees, wants to make home testing more widely available by next spring.
The company intends to ask the FDA to modify its emergency use authorization next spring to allow patients to communicate with prescribing doctors through a website. If the provider agrees the person should get a test, the kit would be delivered overnight to the person’s home.
In a news release, Lucira said the test will be available on a limited basis while it builds up its manufacturing capability. The company did not immediately say through a spokesman how many test kits will be made.
“Lucira is committed to making at home testing accessible and anticipates its test will cost around $50,” the news release said.
In August, Abbott Laboratories gained approval for a rapid antigen test using “lateral flow” technology, similar to a pregnancy test. The U.S. Department of Health and Human Services purchase 150 million tests Abbott makes. These rapid tests already are being used by states and nursing homes, but because the federal government has purchased all the tests so far, none are yet available for consumers to purchase.
While preliminary data shows promising results on two COVID-19 vaccine candidates, they likely won’t be widely available to the general public until mid-2021. Testing remains critical to identify who has the virus and must be isolated to prevent the spread. Everyone else is urged to keep their distance from others, wear masks and wash their hands.
But some experts like Dr. Michael Mina, an infectious disease epidemiologist at the Harvard T.H. Chan School of Public Health, say the federal government has been too slow to green light a new generation of COVID home tests that can be used by anyone, with or without symptoms. Such widespread, inexpensive testing is key to allowing Americans to resume normal activities while isolating themselves when a positive test shows they have the virus.
On a call with reporters Wednesday, Mina reiterated his call for more aggressive federal action on rapid home tests. He says the FDA needs to evaluate these tests in a public health context rather than an individual medical product.
“This is the worst national catastrophe that has happened on our soil in decades – it’s destroying lives. It’s destroying retirements. It’s destroying the economy,” Mina said. “And yet we’re sitting here actually having a discussion of clapping about a very small startup company getting a new product on the market that will be available in April.”
The FDA issued a document in July calling for home tests to correctly identify the virus at least 90% of the time. A high-ranking FDA official overseeing testing told USA TODAY the agency will consider tests with lower sensitivity.
Beyond test accuracy, pathologists such as Godbey said it’s important to ensure tests are accurate and also test results are reported to public health agencies.
“You want to make sure any test that is performed is accurate because bad data is worse than no data at all,” Godbey said.
Ken Alltucker is on Twitter as @kalltucker or can be emailed at [email protected]
This article originally appeared on USA TODAY: FDA approves first home COVID test: Here’s why most Americans won’t get it before next spring