The test is authorized for point-of-care settings, such as physician offices, emergency rooms and certain schools. Healthcare providers using Abbott’s test will swab a patient’s nose, transfer the sample to a test card and wait 15 minutes to read the results directly from the card.
“This means people will know if they have the virus in almost real-time. Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a news release.
Abbott said it plans to make up to 50 million tests per month available in the U.S., beginning in October.
The FDA news release noted that antigen tests, while generally specific, are not as sensitive as molecular ones, and their results should be taken into consideration along with relevant clinical observations, patient history and epidemiological knowledge.
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