The 15-minute test was granted emergency authorization by the FDA earlier this week.
The White House has announced the completion of a contact with pharmaceutical developer Abbott to produce and deliver 150 million units of the BinaxNow COVID-19 Ag Card Point of Care SARS-CoV-2 diagnostic tests for the intention of bolstered nationwide testing for coronavirus 2019 (COVID-19).
The test, which was granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) this week, is capable of delivering user results on the same testing device within 15 minutes.
At a cost of $5 USD per test, the federal government deal totals $750 million to Abbott.
In a statement accompanying the deal, Alex Azar, MD, Secretary of the US Department of Health and Human Services (DHHS), said the introduction of the new rapid antigen test bolsters the nation’s testing capabilities.
“By strategically distributing 150 million of these tests to where they’re needed most, we can track the virus like never before and protect millions of Americans at risk in especially vulnerable situations,” Azar said.
Upon granted emergency use, the FDA stated the test will be made available for use at point-of-care settings, including physician’s offices, emergency settings, or certain schools. It’s been authorized for use in patients with suspected COVID-19, as advised by their healthcare provider within 7 days of symptom onset.
The FDA emphasized the test—which they likened in utility and convenience to standard pregnancy tests—is very specific as an antigen test, but lacks the sensitivity of molecular tests.
“Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the FDA wrote. “Negative results from an antigen test should be considered in the context of clinical observations, patient history and epidemiological information.”
Abbott previously stated this week it is capable of producing 50 million tests per month in the US starting this October.