UPPING THE ANTE ON COVID-19 ANTIGEN TESTING

BinaxNOW: With a swab and a card, reliable coronavirus test results in 15 minutes.

Upping the Ante on COVID-19 Antigen Testing

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

  • The healthcare worker opens the card and lays it flat on a countertop.
  • Extraction reagent is added to the test card, which is about the size of a credit card.
  • A nasal swab is taken from the patient.
  • A technician inserts the swab into the test card, folds over the cover and in 15 minutes, reads the result.
  • People who use the app and receive a negative test result will get a temporary encrypted digital health pass via a QR code (similar to an airline boarding pass) sent to the NAVICA app. The digital pass is renewed each time a person receives a negative test result and includes the date of the latest test result submission. Organizations will be able to view and verify the information on a mobile device to help make entry into these places easier, along with hand-washing, social distancing, enhanced cleaning and mask-wearing.
  • Those who test positive will receive a message through the app telling them to quarantine and talk to their doctor.

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…

  • Easy to use.
  • Affordable.
  • Highly portable, requiring no instrumentation.
  • Reliable, with 97.1% sensitivity and 98.5% specificity.
  • Fast, with results in 15 minutes.

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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