Why no rapid at-home COVID-19 tests have been FDA-approved

Public health experts have said that rapid at-home COVID-19 tests could help the U.S. bring the coronavirus pandemic under control, but concerns about the tests’ reliability and how consumers may use the tests have hindered test developers’ attempts to receive FDA approval, Politico reported. 

Test developers are trying to create an at-home COVID-19 test that could be bought over-the-counter and deliver results at home within minutes, similar to how a pregnancy test can. Such a test could let people screen themselves before going to work or school, which could in turn reduce reliance on testing labs and quickly identify new infections, Politico reported.

The FDA has only approved a similar type of test once, for HIV. The agency has authorized other COVID-19 tests that can be taken at home, such as those made by the company P23 that are being sold at Costco, but those still have to be sent back to a testing lab for results. 

FDA diagnostics director Tim Stenzel told Politico that he’s told his staff he’s “very  interested in them authorizing a good home test as soon as possible.” But such a test would have to meet strict standards. The agency said in July that any at-home test should be able to diagnose at least 90 percent of COVID-19 infections in people whether they are symptomatic or not and should have a false positive rate of 1 percent or less. 

The FDA has also said test developers have to make sure that adults of different ages, education levels and English proficiency can use the test.

Experts are also concerned about the risks of false negatives, Politico reported, which some people might interpret as permission to go to parties or otherwise break social-distancing protocol. Even if a negative result is accurate, that could mean that a person is in the early stages of COVID-19 infection. 

“If this was a disease that only impacted the individual, then it wouldn’t be such a problem. The problem is that there will be a cohort of people who will take the test, find out that they are presumably negative, but they really weren’t, and go out and infect other people,” Georges Benjamin, MD, executive director of the American Public Health Association, told Politico.

Another concern is how public health officials would track test results from an at-home test. If at-home testing becomes widespread but there’s no way to track the results, it could harm the country’s defense against COVID-19, Peter Lurie, MD, president of the Center for Science in the Public Interest, told Politico

Test developers have said they likely won’t seek an emergency authorization from the FDA for at-home COVID-19 tests until later this year or early next, Politico reported. 

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