1st Rapid Coronavirus Test That Gives Results at Home Approved by FDA
The emergency use of a rapid coronavirus test performed entirely at home was used for the first time Tuesday from Lucria Health, a California manufacturer.
The Food and Drug Administration announced the test will require a prescription for future use, likely limiting its initial use, however, it’s an important step to expand testing options.
The company’s test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed as lights labeled positive or negative, which can take up to 30 minutes.
“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,” Dr. Jeff Shuren, director of the FDA’s devices center, said in a statement, according to ABC 7 News.
The FDA said Lucira’s test was also authorized for use in doctor’s offices and testing sites and that doctors will be required to report the home test results.
This is only the second infectious disease at-home test the FDA has approved, the first was for HIV.
“I think increased testing closer to patients, including in the home, is the way of the future,” said Dr. Robin Patel of the Mayo Clinic, according to ABC 7. “But there are considerations that have to be addressed to make sure that this is done in a safe and effective way.”
The new testing kit is expected to be available nationally through health care providers by early spring 2021.