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FDA At-Home Testing Ban Stands in the Way of Faster Coronavirus Care

March 26, 2020

March 26, 2020
By Tom Patterson

To help halt the spread of COVID-19, the field of medicine is getting creative. Drive-thru testing sites are opening up around the country, for example, to help keep potentially contagious people from infecting the healthy. Another helpful option would be at-home sample collection, which has been recommended by experts as a way to not only increase the volume of testing, but also lower the risk and reduce the workload of medical personnel.

But when it comes to at-home coronavirus testing, government has been standing in the way, preventing a possible solution to help get treatment more rapidly to those who need it.

All you have to do is look at the numbers to see that the United States has a clear coronavirus testing problem. COVID-19 testing in the U.S. has notably lagged—far behind the hard-hit countries of Italy and South Korea—making treatment and isolation strategies difficult to administer. But recently, several start-up businesses have pioneered the use of at-home sample collection kits to broaden access to coronavirus testing. Some are already experienced in administering at-home tests; Nurx, for example, already provides at-home testing for sexually transmitted infections. At-home coronavirus testing would definitely help alleviate the obvious burden on medical professionals during this crisis.

For at home-coronavirus testing, an at-home sample is collected by simply swapping the nasal mucosal surface, which is then safely transported with approved shipping materials to certified labs where the results are reviewed by board-certified physicians. The accuracy of the tests have been validated by peer-reviewed studies, according to the companies administering the tests. The results are reported to the appropriate authorities, and patients are connected with physicians when needed.

Cool, huh? Not according to the U.S. Food and Drug Administration (FDA), which issued a directive in mid-March banning the use of at-home sample collecting. Testing was immediately discontinued, and all the specimens already submitted were destroyed. According to the FDA, apparently only trained nurses and technicians are able to run a swab over the inside of someone’s nose. And as a result, those who may have COVID-19 are forced to wait longer to be tested—or may have to forgo being tested at all.

Americans aren’t asking for anything extraordinary from the FDA. But we would like for an agency charged with protecting us to cease doing harm. Facing massive disruption of their personal and financial lives, Americans are eagerly awaiting possible solutions to curb this pandemic. Yet FDA bureaucrats continue to cling to their usual rules, protocols, and one-size-fits-all-circumstances mentality. That approach is preventing Americans from getting the tests and medicines we need to emerge from our national nightmare.

Former Arizona lawmaker Tom Patterson is a retired emergency physician.



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