Abbott received an emergency use authorization for its BinaxNOW Covid-19 test to be used without a prescription. Photo credit: Abbott Laboratories

 

As the Biden Administration emphasizes over-the-counter tests in its pandemic response, the Food and Drug Administration gave the green light to two more this week. It gave an emergency use authorization to Abbott’s BinaxNow and Quidel’s QuickVue tests to be used at home, without a prescription.

“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,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release.

Abbott’s BinaxNow test was originally authorized for at-home use in December. It’s a rapid antigen test that uses a nasal swab. But it’s better known for being the test that the White House relied heavily on to screen people for Covid-19 last year, with mixed results, as it’s not clear how effective the test was in people without symptoms.

A study published by the CDC in January found that it could miss up to two-thirds of asymptomatic cases. But a separate study published in December found it detected 97.5% of cases in people who were asymptomatic. As part of the EUA, Abbott will conduct a study to see how the test performs in people without symptoms.

People will be able to use the test at home without a prescription, and Abbott plans to sell the tests in boxes of two.

Separately, the FDA also gave an EUA to an antigen test developed by Quidel, which had a sensitivity of 96.6% and specificity of 99.3% across 194 samples.

The FDA still cautioned that users should treat negative results as presumptive, and if there’s a high likelihood that they might have been exposed to the virus, they may want to confirm their result with a molecular Covid-19 test.



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