The FDA has granted emergency use authorization to the first complete at-home coronavirus test developed by Lucira Health in California. Requiring a prescription from a health care provider, the test involves a simple nasal swab, is projected to cost about $50 or less, and can return results within about 30 minutes.
While other tests previously authorized by the FDA allow patients to collect samples at home to be shipped to a lab for processing, Lucira’s test eliminates the need for an intermediary. “Today’s authorization for a complete at-home test is a significant step toward the FDA’s nationwide response to COVID-19,” Jeff Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
Lucira’s test uses a loop-mediated isothermal amplification reaction (LAMP) to detect the virus, rather than the polymerase chain reaction (PCR) technique used by laboratory tests. The LAMP method is faster, but less accurate, than PCR. According to results from a small study of people with symptomatic coronavirus infections conducted by Lucira, the LAMP test detected 94.1% of infections found by a PCR-based test and correctly identified 98% of uninfected people. It has not been evaluated in asymptomatic people infected with the virus.
Source: The New York Times, November 18, 2020.