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Why Abbott BinaxNOW™?

• Most widely-used end-to-end Covid-19 testing solution developed by Abbott Laboratories
• FDA Emergency Use Authorization (EUA) received
• Results reporting in 15 minutes
• High sensitivity and specificity rates (see specific tests)

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Home Test with Digital Health Pass

Abbott BinaxNOW™ COVID-19 Ag Card Home Test, Enabled by THE IV DOC, utilizes a digital platform to virtually guide the user through the test process from beginning to end. The test delivers results in just 15 minutes with no instrumentation, using proven lateral flow technology.

• Results reporting in 15 minutes
• Test sensitivity of 97.1% and specificity of 98.5%
• THE IV DOC ensures authentication
• Digital Health Results sent to mobile app

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On-Site and Virtual Testing

This Abbott BinaxNow™ COVID-19 Ag Card Test is perfect for larger gatherings, such as those returning to workplaces, conferences, and professional sporting events. It is a rapid antigen test (not a PCR test), and is authorized for use in settings operating under a CLIA Certificate. Tests should be administered by a medical professional or trained administrator. Packaging images may vary.

• Results reporting in 15 minutes
• Test sensitivity of 97.1% and specificity of 98.5%
• 40 tests in each box, 1 reagent vial per box
• No need to send results to a lab
• Prescription is not needed

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Which Test is Right For Your Organization

TEST SPECIFICS	Home Test	Home Test with Digital Health Pass	On-Site Test
Use Case	Home & On-Site: Workplaces, Consumers	Home & On-Site: Where Digital Health Pass is required: Travel, Workplaces, Events, Education	On-Site: When large quantity testing is needed: Conferences, Professional Sports, Workplaces
FDA Emergency Use Authorization(EUA)	Yes	Yes	Yes
Home Test	Yes	Yes	No
Digital Health Pass	No	Yes	No
Prescription Required	No	Yes	No
CLIA Certified Facility	No	No	Yes
Test Administration	Self	Virtually Guided - Self	Virtually with Medical Professional or on-site withMedical Professional
Results	15 Minutes	15 Minutes	15 Minutes
Test sensitivity and specificity Rates	84.6% and 98.5%	97.1% and 98.5%	97.1% and 98.5%
24/7 Live Support	No	Yes	No
Tests/Kit	2	1	40
Reagent/Kit	2	1	1
Minimum Order Quantity	50 Test Kits	100 Test Kits	3 Test Kits

Frequently Asked Questions

How do you take a sample?

Self-collect your sample from home following the instructions provided, or during the video visit, depending on the test selected. Collecting a sample is an easy to follow and gentle process, no different to using a cotton swab to clean the inside of your nose.

What happens if I receive a positive result?

If you receive a positive result you should remain in self-isolation, and inform your healthcare provider of your result. You should follow the guidance provided by the Centers for Disease Control and Prevention (CDC).

If you develop emergency warning signs for COVID-19, get medical attention immediately. Emergency warning signs include*:

• Difficulty breathing or shortness of breath
• Persistent pain or pressure in the chest
• New confusion or inability to arouse
• Bluish lips or face

*This list is not all inclusive. Please consult your medical provider for any other symptoms that are severe or concerning.

What does FDA authorized mean?

Abbott's BinaxNOW COVID-19 Ag Card Test has been issued an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for prescription home use, which provides consumers with the ability to test themselves from the comfort and safety of their homes.

When there is a critical situation impacting health and safety and there are no FDA-approved or cleared tests available, and other criteria are met, the FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and / or diagnosis of the virus that causes COVID-19.

What does Sensitivity and Specificity mean?

In a diagnostic test, Sensitivity is a measure of how well a test can identify true positives. In a diagnostic test, Specificity is a measure of how well a test can identify true negatives.

How do I place a bulk order for my organization or institution?

For bulk order inquiries, please fill out the quote form at the top of this page with as much detail as possible pertaining to your request.

Restrictions

• Home Test with Digital Health Pass: For use of individuals 15 years or older, ages 4-14 must have an adult present during specimen collection
• Home Test: For use of individuals 15 years or older, or ages 2-14 only if samples are collected by an adult
• Point of Care Test: For use of individuals 15 years or older, ages 4-14 must have an adult present during specimen collection

A Smart Choice for Businesses

Why should businesses invest in at-home or on-site Abbott BinaxNow™ COVID-19 Tests? Not only will these easy-to-use COVID test kit options help slow the spread of the virus, but they will also help keep your business safe and prevent unnecessary shutdowns or halts in service due to outbreaks. Ensure safety at events and during return-to-office rollouts with these excellent options.