The California biotechnology company’s single-use home test kit, which it expects to sell for less than $50, requires a prescription from a doctor. Patients must swab their noses, swirl the sample into a vial, and then wait up to 30 minutes to see the results.
Unlike rapid antigen tests, which experts warn can be unreliable, the kit will test genetic material in a method similar to the laboratory tests that have become the standard for detecting the virus.
FDA Commissioner Stephen Hahn said in a statement that “this new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
While some retailers, including Costco, have already been selling home coronavirus tests to consumers, they are more than twice as expensive — about $130 — and require people to mail their sample to a lab and wait up to two days for results, The Washington Post’s William Wan reported.
Lucira’s rapid, at-home test also means that people who are possibly infected do not have to go into clinics and hospitals to get tested, potentially spreading a virus that has already killed more than 247,000 people in the United States.
Nearly 300 coronavirus testing kits have been authorized to date by the federal agency, according to the Associated Press, but most require either a nasal swab by a doctor or nurse or processing with high-tech lab equipment.
Under its emergency use powers, the FDA also authorized Lucira’s test for medical settings like doctor’s offices, hospitals and urgent care centers. Patients ages 13 and under must have the test administered by a medical professional.
After swirling the nasal specimen into a solution, home-testers plug the vial into a portable device, which uses a light to indicate the test result within 30 minutes.
In recent months, companies have been racing to see who could be first to provide an at-home test, Wan reported. Many manufacturers believed the test could be especially helpful this winter, with infections surging and consumers wanting to get tested before holiday gatherings.
“At a time when so many people feel like they’ve lost control of so much of their lives, it would put power back in their hands,” Mara G. Aspinall, a biomedical diagnostics professor at Arizona State University, told The Post last month. “That’s no small thing.”
Scientists have weighed the merits of two different ways of detecting the virus. Some of the two dozen or so companies trying to develop home tests have focused on polymerase chain reaction (PCR) tests, a molecular process that is more precise but also more expensive and takes longer.
Many more manufacturers are close to developing at-home antigen tests, which detect proteins on the surface of the virus. But these rapid tests are less sensitive, producing false negatives that could give people a false sense of security.
In July, the FDA issued guidelines noting that any at-home test must be accurate and easy enough for untrained people to use without confusion. Antigen tests sold directly to consumers must be more accurate than those used in medical settings up until now, the agency said, because consumers at home will be left to interpret the results on their own.
Lucira said on its website that the company’s at-home test relies on molecular nucleic acid amplification technology, which is designed to detect whether an individual is shedding the coronavirus that causes covid-19. Before the pandemic, the manufacturer was focused on developing similar technology for an at-home flu test.
The FDA’s emergency use authorization for the Lucira home test requires prescribing health professionals to report test results from patients according to local, state and federal requirements.
Doctors and public health specialists had expressed worries about reporting and receiving data from at-home tests, because labs are not involved. These experts fear that without clear mechanisms, the country would be flying blind as it navigates the pandemic.
William Wan and Laurie McGinley contributed to this report.