U.S. Approves First At-Home Test Kit for Detecting Covid-19
The U.S. gave the greenlight for the first Covid-19 diagnostic kit for self-testing at home.
(Bloomberg) -- The U.S. gave a green light to the first Covid-19 testing kit to be used in the home, adding a new tool to battle the pandemic as nationwide testing capabilities come under more strain.
The Food and Drug Administration issued an emergency use authorization to Lucira Health Inc.’s rapid-result All-In-One Test Kit, according to a statement from the agency on Tuesday. The kit is expected to cost around $50, the company said, and consumers will need a prescription to acquire it.
While some Covid-19 tests allow people to to mail in samples collected at home, this is the first that can be fully self-administered and provides results at home in 30 minutes or less. The clearance comes at a time when the country -- which has the world’s largest number of cases, at more than 11 million -- is fighting a fierce resurgence of infections.
Initially, Lucira said, there will be limited availability as the company builds up manufacturing, with national access to the kit planned by early spring 2021.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen Hahn in the statement.
The Lucira test is a molecular assay, a test that detects the virus’s genetic material and is considered highly reliable, unlike antigen tests. It works by swirling the self-collected sample swab in a vial that’s then placed in a test unit, which has a light-up display that shows results.
In addition to home use, the product is also authorized for use in doctor’s offices, hospitals and emergency rooms.
The home test could also help take some of the strain off labs that are facing both a sharp rise in demand and supply shortages. But Michael Mina, a Harvard epidemiologist who has advocated for wide use of cheap, rapid tests, called the development a “very, very small step.”
The new product’s cost, complexity to manufacture and limited early availability are among the factors that will curtail public health applications, he said.
“Why, why, in the middle of November, does anyone need a doctor’s prescription to get a Covid test?” he said. “These tests could have allowed Thanksgiving to happen normally” if they were widely accessible.
California, Miami
Headquartered in Emeryville, California, Lucira is closely-held and employs about 40 people. The test will be rolled out first to patients at Sutter Health in California and Cleveland Clinic in the Miami area.
Only about 50,000 or 100,000 of the assays will be available each month, and it’s indicated only for people with symptoms, U.S. Department of Health and Human Services Official Brett Giroir told NBC’s Andrea Mitchell.
The test was validated in a study that enrolled more than 100 people from diverse backgrounds, the company said. When the results were compared with a highly reliable assay, positive results were aligned 94% of the time, and negative results in 98% of cases.
Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said Tuesday that more widespread testing that can catch people who lack symptoms will be key to curtailing community spread, in remarks at the New York Times DealBook Online Summit.
“What we really need is a point-of-care testing that people can essentially do at home, like a pregnancy test,” he said.
U.S. regulators have been cautious about introducing self testing to date, as it runs the risk of introducing human error. Cases may also go unreported to officials. Both have emerged as issues in the deployment this year of rapid antigen tests, which like Lucira’s test provide results where a test is taken, instead of being sent out to a laboratory.
The FDA said health-care providers are required to report results from the Lucira test to the government.
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