PRODUCTS & INNOVATION
UPPING THE ANTE ON COVID-19 ANTIGEN TESTING
BinaxNOW: With a swab and a card, reliable coronavirus test results in 15 minutes.
Aug 26 2020
Our lives have been shuffled and shuffled again ever since humanity was dealt the bad hand of COVID-19.
As vaccine research continues, health experts have pushed all-in to slow the spread of the disease through diagnostic testing, face coverings and social distancing.
Even still, each decision and every moment can feel a bit like a gamble with your health.
We don't like that. So, we're upping the testing ante again — and working to stack the cards in your favor.
Cue our sixth COVID-19 test, the BinaxNOW™ COVID-19 Ag Card rapid antigen test, which has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test offers results in 15 minutes and is available as an aid to diagnose the virus that causes COVID-19.
The BinaxNOW test can be displayed on our new optional app — available at no charge — for iPhone and Android devices called NAVICA™. This first-of-its-kind app will allow people who test negative to have a temporary encrypted digital health pass that displays their results.
"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," said Robert B. Ford, president and chief executive officer, Abbott. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use and scalable test, and a digital health tool to help us have a bit more normalcy in our daily lives."
Here's How It Works
A Standout COVID-19 Test
The BinaxNOW test, which is for use by healthcare professionals, has features that make it desirable for testing millions. It's…
BinaxNOW COVID-19 Ag Card joins our previously launched tests, including high-volume m2000 and Alinity™ m molecular laboratory systems, ID NOW™ rapid molecular point-of-care platforms, antibody tests for our high-throughput ARCHITECT® i1000SR and i2000SR and Alinity i laboratory instruments. All are available in the U.S. through FDA EUAs.
We will ship tens of millions of tests in September and will ramp manufacturing to 50 million tests a month in October. Abbott is manufacturing the test at massive scale in two new U.S. facilities.
The ability to test anyone suspected by their healthcare professional of having an active COVID-19 infection nearly anywhere makes this BinaxNOW test a useful tool for reducing the risk of novel coronavirus and helping people navigate everyday life.
And if you're unsure whether you've already been infected with COVID-19 and want to know via antibody testing, you can connect with testing centers here.
Beyond COVID-19 Testing
Diagnostic testing is just one facet of Abbott's response to the COVID-19 pandemic.
We're working across our company — and in partnership with others — to support communities worldwide with resources and technologies to fight this ongoing health crisis by ensuring continued access to medical devices, diagnostics, medicines and nutrition products without disruption.
Our technologies are helping people maintain their health through telehealth to their healthcare providers. And we're well suited to help you be in your best health when the world reaches a post-quarantine state.
When it comes to fighting the spread of COVID-19, we're all-in.
The BinaxNOW™ COVID-19 Ag Card EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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