YOUR COVID-19 TESTING QUESTIONS

LAST UPDATED DATE: MAR 22, 2023

WITH THE PUBLIC HEALTH EMERGENCY ENDING IN MAY 2023, WILL THE EMERGENCY USE AUTHORIZATIONS ON YOUR TESTS STILL BE VALID?

Yes, they will. The FDA shared that the ending of the public health emergency declared by HHS under the Public Health Service Act will not impact FDA’s ability to authorize devices, treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met. You can learn more here.

ARE YOU PURSUING 510(K) CLEARANCE FOR YOUR COVID TESTS?

Yes, we are. COVID-19 testing continues to be an important tool as we transition from a public health emergency to co-existing with the virus. Abbott is committed to keeping COVID-19 testing available for people to access at their doctor's office, retail pharmacy and for use at home.

DO YOU HAVE A TEST THAT DIFFERENTIATES BETWEEN COVID AND SIMILAR VIRUSES?

Yes. We have both a lab-based test a rapid point-of-care test that can differentiate between COVID-19, flu A and B and RSV. You can learn more about our lab-based test, Alinity m, here. And you can learn more about our rapid point-of-care test, ID NOW, here

WHAT TESTS DO YOU HAVE FOR DETECTING COVID-19?

We have developed twelve different tests globally that help detect an infection of COVID-19.

Our most popular test is our rapid antigen BinaxNOW COVID-19 Self Test which provides results in 15 minutes. 

WHAT IS ANTIGEN TESTING?

Antigen tests detect proteins of the SARS-CoV-2 virus that form during the infection cycle and indicate that a person has an active infection. Rapid antigen tests offer several important benefits. They are highly portable, scalable, easy-to-use and provide a flexible approach to helping more people in more places get access to reliable testing in a cost-effective way. They are best at detecting when people are most infectious, so they know to stay home and isolate, minimizing the spread of COVID-19.

HOW DO YOUR MOLECULAR AND ANTIGEN TESTS WORK?

Molecular and antigen tests work in different ways to detect viruses.

Take a look at this infographic on how coronavirus molecular testing works. To learn how our molecular point-of-care testing on ID NOW works, see this how-to video.

For more information on how antigen testing works, check out this article.

WHAT'S THE TURN-AROUND TIME FOR YOUR TESTS?

Molecular tests that run on our m2000 system have the ability to run high volumes of up to 470 tests in 24 hours. Learn more about m2000 here: https://abbo.tt/3b8bASF

Alinity m systems have the ability to run high volumes of up to 1,080 tests in 24 hours. Learn more about Alinity m here: https://abbo.tt/2zrt52N

ID NOW delivers positive results in as little as 5 minutes and negative results in 13 minutes. Learn more about COVID-19 testing on ID NOW here: https://www.abbott.com/IDNOW.html?CID=OUS_OK  

BinaxNOW provides results in 15 minutes. Learn more about COVID-19 testing on BinaxNOW here: https://www.abbott.com/BinaxNOW-Tests-NAVICA-App.html

HOW ACCURATE ARE YOUR TESTS?

We have always made highly reliable and accurate tests for other infectious diseases such as HIV and hepatitis, and we're highly confident in our tests since we’ve used the same approach to development. All of our COVID-19 tests met all testing criteria under the FDA's emergency use authorization (EUA). 

HOW MANY TESTS ARE YOU MAKING?

Since the start of the pandemic, Abbott has produced and shipped more than 2 billion COVID-19 tests. We continue to work closely with our customers around the world to bring testing to where it’s needed most. 

WHERE ARE YOUR TESTS AVAILABLE?

Our antibody and molecular lab tests are available around the world, as well as our ID NOW rapid molecular test. For our rapid antigen tests, BinaxNOW is available in the U.S. and Panbio is available in many countries outside of the U.S. 

HOW CAN TESTS BE ACCESSED?

Most of our tests may be available through your healthcare provider or at retail pharmacies. Our BinaxNOW Self Test is available over the counter, online and in retail stores including CVS, Walgreens and Walmart.

If you're with a hospital, lab or healthcare provider, please see the contact details below.

For general questions about BinaxNOW COVID-19 Ag Card: https://abbo.tt/2Qk76jp

For general questions about ID NOW:  https://abbo.tt/3IZGfVW

For general questions about m2000: https://abbo.tt/3fcjz2P

For general questions about ARCHITECT: https://abbo.tt/2X4m9RZ

For general questions about Alinity i: https://abbo.tt/335jaN6

For general questions about Alinity m: https://abbo.tt/2X754XS

HOW DOES EMERGENCY USE AUTHORIZATION (EUA) SUBMISSION PROCESS WORK?

The FDA has made tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Services' declaration that circumstances exist to justify the development of in vitro diagnostics (IVDs) under EUA for the detection and/or diagnosis of 2019-nCoV. Click here for more info: https://abbo.tt/2X7xwZo

WHEN SHOULD I TEST?

Please check the CDC resources on how to protect yourself and what to do if you think you are sick: https://abbo.tt/3hJSINd

HOW DO I KNOW IF MY BINAXNOW SELF TEST HAS EXPIRED?

The FDA granted approval for a 22-month shelf-life extension for our Self Tests. You can double check the expiration date of the tests you have on hand via our Lot Look Up Tool, so you know you’re getting the most reliable results. 

Here’s how to check the expiration date of your test:

  1. Find the expiration date on the box. First, find the sticker on the bottom right-hand corner on the back of the box. Next to the hourglass symbol, you’ll see the listed expiration date. If the date has already passed, continue to Steps 2 and 3 to see if the expiration date has been extended by the FDA.

    lot number

  2. Find the lot number on the box. The lot number is beneath the expiration date, next to the letters “LOT.”

    lot number

  3. Search the lot number to find the expiration date extension. Input your lot number via our Lot Look Up Tool at rapidtest.abbott/binaxnow to confirm the expiration date extension of your test.

Reminders:

  • Finding the lot number is most important. If your test’s lot number appears, trust the extended expiration date, even if the printed expiration date doesn’t match.
  • If your test’s lot number doesn’t appear, the test’s expiration date may not have been extended. You can recycle the box, but should dispose of the test card, nasal swab and test solution in common household waste, in line with the test’s instructions for use.

LOOKING FOR MORE INFO? CHECK OUT THESE HELPFUL LINKS.

Learn more about Abbott's approach to tackling the coronavirus: https://abbo.tt/2WHMDco
Read more about ARCHITECT: https://abbo.tt/3abd0eq
Read more about ID NOW: https://www.abbott.com/IDNOW.html
Read more about m2000: https://abbo.tt/2U1WMiU
Read more about Alinity i: https://abbo.tt/2SWCvtU
Read more about Alinity m: https://abbo.tt/2zrt52N
Read more about BinaxNOW COVID-19 Ag Card: https://abbo.tt/3hZPfNx

LOOKING FOR MORE INFO? CHECK OUT THESE HELPFUL LINKS.

Learn more about Abbott's approach to tackling the coronavirus: https://abbo.tt/2WHMDco
Read more about ARCHITECT: https://abbo.tt/3abd0eq
Read more about ID NOW: https://abbo.tt/3KI9smQ
Read more about m2000: https://abbo.tt/2U1WMiU
Read more about Alinity i: https://abbo.tt/2SWCvtU
Read more about Alinity m: https://abbo.tt/2zrt52N
Read more about BinaxNOW COVID-19 Ag Card: https://abbo.tt/3hZPfNx

These tests have not been FDA cleared or approved. These tests have been authorized by FDA under EUAs for use by authorized laboratories and have been authorized only for the detection of nucleic acid from SARS-CoV-2 or detection of IgG antibodies against SARS-CoV-2, and not for any other viruses or pathogens. These tests are 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.