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FDA under pressure to speed approval of quick, at-home coronavirus tests

The U.S. Food and Drug Administration is under fire for setting what critics say are near-impossible standards for quick, at-home Covid-19 tests that could provide a breakthrough in stemming the spread of the virus.

The rapid home tests are not as accurate as the common lab tests done now, but can usually detect when an individual has enough of the virus to be contagious. Perhaps most importantly, experts say, the rapid tests could be mass-produced cheaply, allowing many people to test themselves frequently and get results in minutes, before venturing out to schools and workplaces.

Officials and public health experts, including White House advisors Dr. Anthony Fauci and Dr. Deborah Birx, have supported the development of rapid tests that can be conducted either at home or in places like schools, offices, pharmacies and nursing homes. Last week, a bipartisan group of governors from Maryland, Louisiana, Virginia, Massachusetts, Michigan, and Ohio announced they were teaming up with the Rockefeller Foundation to scale up to 30 million tests per week with the rapid tests. 

Most of the rapid home tests look for a virus protein called an antigen, instead of replicating virus DNA like the standard lab test that can take several days to report results. These lab tests are highly sensitive, and can detect even a small amount of the virus—but are expensive and time-consuming, requiring labs and technicians. Rapid at-home antigen tests would allow individuals to spit in a tube and wait just 15 or 20 minutes for a result. 

Two companies have so far received FDA approval for faster tests, though these still require machine readers to be interpreted. So far, however, no tests have been approved for at-home use, and a growing number of critics say the FDA has put up hurdles to approval that have delayed their wide availability.


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