FDA Authorizes Two At-Home COVID-19 Tests

FDA Authorizes Two At-Home COVID-19 Tests

The United States Food and Drug Administration authorized two tests on Wednesday that could allow people to be tested for COVID-19 at home without a prescription.

Quidel’s QuickVue test and Abbott’s BinaxNOW tests are the two that were approved this week. NPR reported, “The only other at-home coronavirus test that has been authorized to be sold without a prescription is made by Ellume and is not yet available in stores.”

These tests had already been authorized by the FDA in order to test people who were exhibiting COVID-19 symptoms, although some were authorized under different names. However, the move this week authorizes testing of people who do not have symptoms when used for serial testing. The FDA has approved three tests with “serial screening claims” in total.

On March 16, the FDA explained that serial testing “involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission.”

At the time, the FDA also cleared the way for companies with tests that have already been authorized to be able to apply for authorization for over-the-counter versions.

On Wednesday, The FDA stated:

Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening. In addition to the tests authorized for OTC use, one serial screening test was authorized for use in a point-of-care (POC) setting without a prescription, and an additional screening test was authorized for POC use with a prescription. The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable. These authorizations follow the FDA’s recent actions to advance OTC and other screening test development.

Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said, “Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country’s pandemic response—many schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19. With the FDA’s authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization. As we’ve said all along, if it’s a good test, we’ll authorize it.”

He continued, “The FDA has taken many steps to support test development throughout the pandemic, including authorizing tests quickly, offering many avenues for test developers to work with us to get their tests on the market, if shown to be accurate and reliable, and issuing enforcement policies for COVID-19 tests. As the pandemic has progressed, we have worked with test developers wishing to add screening claims.”

In a press release, one of the companies whose test was authorized, Abbott, stated that the “BinaxNOW COVID-19 Self Test is identical to the professional-use test, used since August 2020, bringing the most studied and widely used rapid antigen test to retail shelves across the country.” It also added that the self-test “will be available nationwide and in large quantities at major food, drug and mass merchandiser retailers nationally and will be priced affordably, similar to common over-the-counter (OTC) tests.”

Quidel, the other company, also issued a press release, stating that their at-home test “shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% of the time, delivering confidence to patients running the test and facilitating informed discussions with doctors.”

The CDC Data Tracker shows a sharp decline in COVID-19 cases across the United States since mid-January, with the case numbers seeming to plateau in the past month.

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Originally Posted on: https://www.dailywire.com/news/fda-authorizes-two-at-home-covid-19-tests
[By: Charlotte Pence Bond

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