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A push for FDA to authorize do-it-yourself COVID-19 tests that deliver rapid results

Some leading public health experts are urging federal regulators to approve at-home COVID-19 tests. The accuracy of these tests are at the core of the debate.

HARRISBURG, Pa. — Do-It-Yourself COVID-19 tests are gaining support from leading public health experts. Some doctors believe rapid, at-home tests could help the country turn the corner on the pandemic.

Scientists are joining a campaign to persuade the U.S. Food and Drug Administration to authorize at-home COVID-19 tests that deliver results within minutes. They are pushing for quick tests that cost consumers only $1 each.

Many healthcare professionals believe these tests are critical to reopening schools, restaurants and workplaces. Public health experts have been fighting for rapid COVID-19 testing, for months.

“There was some testing over time, but not enough,” said Adam Marles, president and CEO of LeadingAge PA.

“I am hopeful that those types of rapid, accurate tests will be available. That would make things much easier,” Pennsylvania Health Secretary, Dr. Rachel Levine, told FOX43 in June.

We have to wonder, where are they? The FDA still has not authorized these tests. The agency said they can miss infections and produce more false negatives. To some doctors, that’s why frequent testing is key.

Joseph Allen, Assistant Professor of Exposure Assessment Science at Harvard T.H. Chan School of Public Health, sent out a series of tweets on “quick daily tests.” In one tweet he writes, “With current testing methods, you’d be facing a 7-day delay for results. If we start taking daily quick tests every day, we can quickly identify those who are most infectious and slow the spread of the virus.”

The FDA hasn’t budged. Their guidelines require a rapid, at-home COVID-19 test to detect at least 90 percent of cases. Those tests do not exist yet. The FDA has provided a template for developers, noting the importance of affordable COVID-19 tests that can be done entirely at home.

“These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening,” the FDA said in a July 29 statement.

Current COVID-19 tests that are processed in labs are able to detect 95 percent of cases. The problem, however, is that some patients are waiting more than a week to get their results.

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