- The Food and Drug Administration on Tuesday granted emergency authorization to Lucira Health for the first coronavirus diagnostic test for full self-testing at home.
- Lucira's single-use molecular test kit can deliver results in 30 minutes or less and is authorized for prescription home use with self-collected nasal swab samples for people age 14 and older suspected to have COVID-19 by their doctor. The company expects its testing kit to cost about $50 and to be available nationally by early spring 2021 through providers.
- Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement that individuals "will be able to take immediate action, based on their results, to protect themselves and those around them."
While FDA has previously authorized COVID-19 diagnostic kits that allow an individual to self-collect a sample at home, Lucira's is the first test that can also provide results at home without being processed at an outside lab.
Some public health experts view the widespread availability of in-home self tests as important in dramatically increasing the nation's capacity for coronavirus testing, while easing pressure on labs and healthcare systems. The U.S. this week reported a daily average of nearly 160,000 new COVID-19 cases.
Though Lucira's test is expected to be available nationally by early spring 2021, the molecular diagnostic will be first made available in the "near future" to patients of Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale.
Michael Mina, a professor of epidemiology at Harvard's T. H. Chan School of Public Health, has previously expressed concerns that, even with an EUA, an at-home test might not be mass produced in sufficient numbers initially needed for large-scale screening.
Mina also contends there's been no effort to date from the FDA or the Centers for Disease Control and Prevention to provide "serious guidance" about how these kinds of tests could be deployed and used. "I worry that we are going to have a haphazard rollout of them," he said.
Early in the pandemic, the FDA questioned whether the average consumer could safely and correctly collect a nasal specimen for COVID-19 testing. Shuren, however, said a fully at-home test "has always been a major priority" for the agency, which is continuing to work with test developers to add more options.
Lucira's test involves swirling a self-collected nasal swab sample in a vial that is placed in the testing unit. A light-up display then shows whether a person is positive or negative. A positive test result can be generated in as few as 11 minutes, according to the company.
FDA noted in its EUA announcement that prescribing physicians must report test results to public health authorities. To help providers with reporting, the agency said Lucira Health has developed box labeling and quick reference instructions.
Some infectious disease experts, however, remain skeptical that people who test positive will report the results to their healthcare providers.
Lucira's website claims its at-home rapid COVID-19 test is comparable to polymerase chain reaction tests for detecting SARS-CoV-2 infections.
Lucira said its diagnostic, which uses a method called loop mediated amplification reaction, was able to accurately detect 94% of infections found by "one of the most reliable FDA authorized" PCR tests, and also correctly identified 98% of the healthy, uninfected people in a clinical trial.