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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.
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.
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.
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.
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.
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.
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
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).
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.
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.
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
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
Please check the CDC resources on how to protect yourself and what to do if you think you are sick: https://abbo.tt/3hJSINd
Abbott received an extension from the U.S. FDA for BinaxNOW Self Tests from 15-month expiration dates to 22-months.
Here's how you can confirm what your new expiration may be:
1. Look on the back of your box for both the expiration date (next to the hourglass symbol) and lot number (next to the word LOT).
2. Visit the FDA’s website to see if your test kit’s lot number has a new expiration date. The FDA has also included a full list of all at-home COVID-19 tests that have an EUA and whether they have an extended expiration.
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
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.
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Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimized for your screen size.