The News Herald (Willoughby, OH)
FDA allows 1st home rapid virus test results
U.S. regulators are allowing emergency use of the first rapid coronavirus test that can be done at home.
WASHINGTON » U.S. regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed entirely at home and delivers results in 30 minutes.
The announcement by the Food and Drug Administration represents an important step in U.S. efforts to expand testing options for COVID-19 beyond health care facilities and testing sites. However, the test will require a prescription, likely limiting its initial use.
The FDA granted emergency authorization to the single-use test kit from Lucira Health, a California test developer.
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.
To date, the FDA has authorized nearly 300 tests for coronavirus. The vast majority require a nasal swab performed by a health professional and must be processed at laboratories using high-tech equipment. A handful of tests allow people to collect their own sample at home — a nasal swab or saliva — that’s then shipped to a lab, which usually means waiting days for results.
Health experts have called for options to allow people to test themselves at home, reducing turnaround times and the potential spread of the virus to others, including health care workers.
Rapid test results are critical to quickly quarantining those who are infected and tracing their contacts. But for months, U.S. testing has been plagued by slow results due to bottlenecks at testing laboratories. There are other rapid tests but most require a small, special machine operated by a health professional to deliver results.
“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.
Lucira said it expects the test to cost $50 and to be available nationwide by next spring.
The Lucira COVID-19 test grew out of research the company was doing to develop an at-home flu test, according to the company’s website. Founded in 2013, Lucira adapted its technology to detect COVID-19 after the outbreak.
The test uses technology similar to genetic laboratory-based tests that are the standard tool for COVID-19 screening. That’s different than most rapid tests currently used in the U.S., which look for viral proteins called antigens — not the virus itself. They typically have lower accuracy for detecting the virus than lab-based tests.
Lucira said its test results matched those of a laboratory-based test 94% of the time when screening for the virus.
Anyone that tests positive using the test should isolate and seek care from a health professional, the FDA said in its release. Those who test negative but still have coronavirus symptoms should consult a doctor; a negative result does not rule out COVID-19 infection.
The FDA said Lucira’s test was also authorized for use in doctor’s offices and testing sites. Currently all U.S. testing sites must report results to state and federal health authorities tracking the pandemic. Doctors will be required to report the home test results.