Doubling Down on COVID-19 Testing

FDA continues push for over-the-counter and other COVID-19 tests

(RxWiki News) The US Food and Drug Administration (FDA) is doubling down on its efforts to approve COVID-19 tests.

The FDA said in a recent press release that it is pushing to bring more COVID-19 tests to the market. This effort, meant to support the fight against the pandemic, includes all kinds of screening tests but focuses on over-the-counter tests for asymptomatic individuals.

To that end, the agency approved several new COVID-19 tests for over-the-counter use.

“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 press release. "With the FDA’s authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization."

The FDA said it has approved three COVID-19 tests to test asymptomatic people multiple times. These include the following:

  • The Quidel QuickVue At-Home OTC COVID-19 test
  • The Abbott BinaxNOW test
  • The BD Veritor System for Rapid Detection of SARS-CoV-2

The FDA approved the first two tests for over-the-counter use. The third test was approved for use in a point-of-care setting (like a pharmacy or doctor's office) without a prescription. The FDA had previously approved all three tests for use in people who are showing COVID-19 symptoms. Now, these tests can be used in people who show no symptoms at all.

Many people who have COVID-19 do not know they have it because they show no symptoms or mild symptoms. Sometimes, the virus runs its course without causing serious symptoms. Other times, it takes a while for the symptoms to develop. In either case, a COVID-19 test could identify the virus before the person shows symptoms.

How does this help with the pandemic? The earlier people know they have COVID-19, the sooner they can isolate at home to stop themselves from spreading the virus.

If you have COVID-19 symptoms or believe you were exposed to someone who does, reach out to your health car provider. They can advise you on whether to get tested and where you should go to do so.

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Review Date: 
April 6, 2021