Rapid COVID Tests: More Important Than Ever

With much of the world calculating when "normal" will return, rapid tests will help us get and stay there.

Strategy and Strength | Apr. 19, 2021

As COVID-19 vaccines roll out, travel slowly increases, and more schools and businesses begin opening their doors, rapid tests that detect the virus have never been so important.

Why? Because getting enough people vaccinated will take time. And even then, scientists and medical professionals are working to understand the length of vaccine immunity and efficacy of the vaccines against variants of the virus springing up around the world.

Rapid COVID-19 tests can quickly and affordably determine who is most infectious so they can quarantine and not spread the virus to their family and friends.

Among the most widely-used rapid tests is Abbott's antigen test, BinaxNOW, which is the size of a credit card, requires no specialized instrumentation and can be used with a first-of-its kind complementary app called NAVICA, allowing people who test negative to display their results on their mobile device. Adding to the convenience, Abbott has launched and begun shipping a self-test that will initially be available at CVS Pharmacy, Walgreens and Walmart without a prescription. The BinaxNOW Self Test will be sold in 2-count packs for an MSRP of $23.99, making it the most affordable over-the-counter COVID-19 rapid test available in the U.S.

"Demand for antigen tests could be enormous," Evercore analysts wrote.1

Abbott's other rapid COVID-19 test is the ID NOW system, a molecular point-of-care test the size of a toaster that's designed to deliver results in 13 minutes.

Chris Scoggins, Abbott's senior vice president of Rapid Diagnostics, gives an inside look at rapid COVID-19 testing, including its real-world benefits, value and impact on recovery.

What's the role of rapid COVID-19 testing in a post-vaccine world?
I think everyone is looking for a silver bullet in this pandemic. Masks aren't a silver bullet alone. Social distancing and testing aren't silver bullets. And although I'm excited about vaccines, they won't be a silver bullet either.

To take a pandemic and move it to epidemic status and get it under control, it will be a multi-faceted approach that requires a concerted effort by the public. This will include widespread, regular testing, mask-wearing, social distancing and hand-washing.

Eventually, a few years from now, when COVID testing ramps down and becomes more like flu testing, the infrastructure put in place because of COVID-19 will remain and play an important role in healthcare. Abbott will have built this new platform outside labs and hospitals that can bring all kinds of rapid tests to people when and where they need them.

RELATED ARTICLE
COVID-19 Testing Innovation Shines at Tech Show

Rapid COVID-19 tests generate quick results, but what are the other benefits?
What's really important is what you're testing for and the progression of the disease and its life cycle. Our rapid antigen BinaxNOW test and our ID NOW molecular rapid test are effective at identifying the virus when you're most likely to transmit it. Which is to say, when you're contagious. They determine: Do you have active virus in you right now? And are you contagious? Those are really important questions that you need to answer in the middle of a pandemic.

The other key benefit is access. These tests are portable, easy to perform and can be performed by healthcare providers in some pretty unique healthcare settings — including parking lots or schools — and the tests are now available for self-use, so you can get your status before running out the door. Beyond availability, the tests also have to be affordable.

How are rapid tests impacting the country's recovery?
They're critical. People are getting tired of the pandemic, so they're starting to travel and spend more time with friends and family. Rapid COVID-19 tests — which are good at identifying people with higher viral loads and who are therefore more likely to be contagious — could help prevent people from unknowingly spreading the virus to their loved ones.

Our complementary NAVICA app, which pairs with BinaxNOW, takes this a step further by enabling people to display a temporary encrypted digital pass with a QR code if they test negative. You could see a NAVICA pass being used in airports, but it could also be helpful in everyday life, such as coming into contact with people in your home and community. It's all about giving people greater confidence.

RELATED ARTICLE
NO IMAGE

What's the value of rapid COVID-19 tests during the pandemic?
This virus has put an incredible strain on our economy. When we have to shut down communities or states, there's a massive negative impact on a micro and macro level. If we can help keep our economy running, the economic impact is obvious.

With rapid COVID-19 tests like BinaxNOW and ID NOW, we can help identify more people who are most likely to be contagious, who have an active virus, so they can isolate from the general population and avoid spreading it. When we do this, we'll have a shot at some semblance of normality when it comes to business, opening schools and the economy rebounding, all of which make this country prosper.

Put the accuracy of rapid COVID-19 tests in context.
A recent study of our BinaxNOW test by the University of California San Francisco found that it detected 93.3% of people who were most likely to be actively infectious.2

If you want to catch someone who's more likely to be contagious, a rapid test can be an excellent tool.

NAVICA App

References

1Evercore ISI: PoC 15 min Antigen Test (TRx needed) opens up +$850 MM rev oppty; Validated in >100 samples, August 26, 2020.

2University of California San Francisco, Rapid COVID-19 Test Shows Promise in Community Test Setting, October 15, 2020.

This story was originally published on Dec. 10, 2020. It was updated on Feb. 15, 2021 to include reference to our announcement of Abbott's launch of its BinaxNOW test for at-home use with a prescription through a virtually guided online service. It was updated again on April 19, 2021 to include reference to Abbott’s launch of its BinaxNOW Self Test.

Important Safety Information

ID NOW
BINAXNOW EMERGENCY USE AUTHORIZATION

The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older. The BinaxNOW COVID-19 Ag 2 Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swab samples from COVID-19 symptomatic individuals tested twice over three days with at least 36 hours between tests within the first seven days of symptom onset.

This test is authorized for use with direct anterior nasal (nares) swab samples from individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested twice over three days with at least 36 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The BinaxNOW COVID-19 Ag Card 2 Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older. The BinaxNOW COVID-19 Ag Card 2 Home Test is to be performed only with the supervision of a telehealth proctor.

The BinaxNOW COVID-19 Ag tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

ID NOW

The ID NOW COVID-19 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 and patient care settings. The test has been authorized only for the detection of nucleic acid 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.