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The FDA has approved 2 rapid coronavirus test products that can be sold in over-the-counter drugs for home use



The U.S. Food and Drug Administration (FDA) approved two rapid over-the-counter coronavirus tests this week, which will soon be available in pharmacies to provide convenient home testing capabilities.

The FDA said in its announcement on Wednesday that it has approved Abbott’s BinaxNow and Quidel’s QuickVue tests, and the public will soon be able to purchase them without a doctor’s prescription.

The FDA conducted a BinaxNOW rapid COVID-19 test at Abbott Laboratories in Tacoma, Washington on Wednesday, March 31, 2021.  The FDA said that Abbott’s BinaxNow and Quidel’s QuickVue tests can now be sold without a prescription, and consumers do not need to repeat the test at home.

The FDA conducted a BinaxNOW rapid COVID-19 test at Abbott Laboratories in Tacoma, Washington on Wednesday, March 31, 2021. The FDA said that Abbott’s BinaxNow and Quidel’s QuickVue tests can now be sold without a prescription, and consumers do not need to repeat the test at home.
(AP Photo/Ted S. Warren)

“Screening tests, especially the over-the-counter drug tests approved today, are an important part of the country’s pandemic response. Many schools, workplaces, communities, and other entities are establishing testing programs to quickly screen for COVID-19. FDA approved A number of tests have been performed, so the public can rest assured that these tests have reached our scientific standards for emergency use authorization. As we have always said, if this is a good test, we will authorize it.” FDA Equipment and Radiology The director of the health center in a statement.

Both tests require the user to collect a sample through a nasal swab and then insert it into the test strip. The result takes 10 to 20 minutes.

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Abbott said its tests will be priced in the “single digits” of each test and should be available in pharmacies, supermarkets and other chains in the “coming weeks”. The company can conduct approximately 50 million tests per month. Quidel did not disclose the price of its test.

Both companies said they would sell the test in two packages. Repeated testing is important to reduce the possibility of false results. Adults can use these two tests to test children aged 2 years and older.

Since the beginning of the disease outbreak, the US Food and Drug Administration (FDA) is expected to greatly expand the scope of cheap home testing advocated by many experts. However, as the number of tests in the United States continues to decline, it has even announced that the number of new coronavirus infections is increasing. , The news was released. Rise again.

However, with the increase in vaccinations, frequent self-testing is considered the key to helping reopen schools, universities and offices.

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Dr. Michael Mina of Harvard University said that as new virus variants spread and researchers study the validity period of vaccine protection, it will be crucial to expand testing methods.

Mina said: “Vaccines are very important, but not the ultimate goal of this pandemic, but everything.” “We need to use other tools in the arsenal, and the wide availability and rapidly expanding test scale make people You can use them in your own home, which will be an extraordinary gain.”

Last month, the FDA relaxed the criteria for reviewing rapid screening tests, after Mina and other experts had criticized them for delaying additional screening for months.

The Associated Press contributed to this report.


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