Thu. Jul 7th, 2022

Diagnostics Tests

Our lives have been shuffled over and over again since humanity received the bad hand of COVID-19. As vaccine research continues, health experts have done their best to slow the spread of the disease through diagnostic testing, face covering, and social distancing. Still, every decision and every moment can feel a bit like a gamble with your health. We don’t like that. So we’re upping the test ante again and working to stack the cards in your favour.

Enter our sixth COVID-19 test, the BinaxNOW ™ COVID-19 Ag Card Rapid Antigen Test, which received emergency use authorization (EUA) from the US Food and Drug Administration (FDA). This test provides results in 15 minutes and is available to help diagnose the virus that causes COVID-19.

The BinaxNOW test can be displayed in our new optional application, available free of charge, for iPhone and Android devices called NOVICA ™. This first-of-its-kind app will allow people who test negative to have a temporary encrypted digital health pass displaying their results.

“We intentionally designed the BinaxNOW test and the NOVICA app to be able to offer a comprehensive testing solution to help Americans feel more confident about their health and lives,” said Robert B. Ford, Abbott president and CEO. “BinaxNOW and the NOVICA app provide us with an affordable, easy-to-use, and scalable test and digital health tool to help us get a little more normal in our daily lives.”

Is that how it works?

  • The health worker opens the card and places it on a counter.
  • The extraction reagent is added to the test card, which is approximately the size of a credit card.
  • A nasal swab is taken from the patient.
  • A technician inserts the swab into the test card, folds 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 NOVICA app. The digital pass is renewed each time a person receives a negative test result and includes the date of the last submission of the test result.
  • Organizations will be able to view and verify information on a mobile device to help facilitate entry to these venues, along with handwashing, social distancing, improved cleanliness and the use of masks.
  • Those who test positive will receive a message through the app telling them to self-quarantine and speak to their doctor.

A Featured COVID-19 Test

The BinaxNOW test, which is for use by healthcare professionals, has characteristics that make it desirable for testing millions. His…

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

BinaxNOW COVID-19 Ag Card joins our previously released tests, including high-volume m2000 and Alinity ™ m molecular laboratory systems, ID NOW ™ rapid molecular point-of-care platforms, antibody tests for our ARCHITECT® i1000SR and high performance i2000SR and Alinity I laboratory instruments. All are available in the US through the US FDA.

We will ship tens of millions of tests in September and increase manufacturing to 50 million tests per month in October. Abbott is manufacturing the test on a massive scale at two new US facilities. The ability to test anyone suspected by their healthcare professional of having an active COVID-19 infection almost anywhere makes this BinaxNOW test a useful tool for reducing the risk of novel coronaviruses and helping people navigate everyday life.

Beyond COVID-19 testing

Diagnostic tests are just one facet of Abbott’s response to the COVID-19 pandemic. We are working across our company, and in partnership with others, to support communities around the world with resources and technologies to combat this ongoing health crisis by ensuring continued access to medical devices, diagnostics, drugs, and nutrition products without interruptions. Our technologies are helping people maintain their health through telehealth with their healthcare providers. And we are well prepared to help you be in your best health when the world reaches a post-quarantine state.