The FDA has authorized its first all-in-one COVID-19 diagnostic that allows people to test themselves within their own home, from a swab to a result in about 30 minutes.
Developed by Lucira Health, the kit shrinks a molecular test for the novel coronavirus’s genetic code down to a handheld unit, complete with all the chemical reagents needed to perform the analysis.
The prescription-only test can be used at home by people ages 14 and older, though it is available to all ages when given in a doctor’s office, clinic or emergency room, with the swabbing being performed by a trained healthcare provider.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen Hahn said in a statement.
After whisking the inside of both nostrils, the swab is placed into a fluid-filled vial. The sample then snaps into the top of the testing unit, which runs off two AA batteries.
The diagnostic uses a steady amount of heat to drive the chemical reactions that multiply the number of copies of the coronavirus’s RNA—a process known as loop-mediated isothermal amplification, or LAMP—before delivering a positive or negative result with an indicator light.
“A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” said Jeff Shuren, director of the FDA’s device center. “Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”
People who test negative and still have COVID-19-like symptoms should follow up with their doctor, the agency said, as a negative result does not preclude an infection. The test comes with instructions on how to report any readings, and healthcare providers who prescribe the test are required to deliver all results they receive to public health authorities.
“There are currently two types of COVID-19 tests that detect whether a person is infected and potentially infectious,” Lucira CEO Erik Engelson said. “Antigen tests detect viral proteins and can provide results quickly.”
“However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests,” Engelson said. “Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests, and considered the ‘gold standard’ for determining if someone is infected.”
The company said it expects the test to be available nationwide by early spring 2021, at a cost of $50. In addition, Lucira plans to file with the FDA next year to allow the test to be prescribed through a telehealth visit, with the kit delivered through the mail. The single-use device was originally developed over five years for use as a flu test, before being redirected toward the COVID-19 pandemic.
“We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently,” John Chou, a physician with the Sutter Health-affiliated Palo Alto Foundation Medical Group, who served as a principal investigator for a study that compared the Lucira test’s accuracy to an unnamed, FDA-authorized molecular laboratory test.
Using samples taken from more than 100 people across Northern and Southern California, positive results from Lucira’s palm-sized unit matched readings from the lab PCR test 94.1% of the time, while aligning with 98.0% of negative results.