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

Test developers are trying to produce an at-home COVID-19 test that could be purchased non-prescription and deliver results at home within minutes, similar to how a pregnancy test can. Such a test might let people evaluate themselves prior to going to work or school, which might in turn minimize reliance on testing labs and rapidly determine new infections, Politico reported.

Another issue is how public health authorities would track test results from an at-home test. If at-home testing ends up being prevalent but theres no method to track the outcomes, it might damage the countrys defense against COVID-19, Peter Lurie, MD, president of the Center for Science in the Public Interest, informed Politico..

Experts are likewise worried about the dangers of false negatives, Politico reported, which some individuals may interpret as permission to go to celebrations or otherwise break social-distancing protocol. Even if an unfavorable result is precise, that could indicate that a person remains in the early stages of COVID-19 infection..

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Test developers have actually said they likely wont seek an emergency permission from the FDA for at-home COVID-19 tests until later on this year or early next, Politico reported..

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FDA diagnostics director Tim Stenzel informed Politico that hes informed his personnel hes “extremely thinking about them authorizing a good house test as soon as possible.” However such a test would need to satisfy stringent requirements. The firm stated in July that any at-home test must have the ability to diagnose at least 90 percent of COVID-19 infections in people whether they are symptomatic or not and ought to have an incorrect positive rate of 1 percent or less..

Public health professionals have said that quick at-home COVID-19 tests might help the U.S. bring the coronavirus pandemic under control, however issues about the tests reliability and how consumers might use the tests have hindered test developers attempts to get FDA approval, Politico reported..

Maia Anderson –
Monday, October 26th, 2020

The FDA has actually just approved a similar kind of test once, for HIV. The company has actually authorized other COVID-19 tests that can be taken at home, such as those made by the company P23 that are being cost Costco, however those still need to be returned to a screening laboratory for results..

” If this was a disease that just impacted the specific, then it would not be such an issue. The problem is that there will be a mate of individuals who will take the test, discover that they are probably unfavorable, however they truly werent, and head out and contaminate other people,” Georges Benjamin, MD, executive director of the American Public Health Association, informed Politico.

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The FDA has also stated test developers need to ensure that adults of various ages, education levels and English proficiency can use the test.