INVESTORS
NEWSROOM
Responsibility
Live Healthy
CONSUMERS
HEALTHCARE PROFESSIONALS
CAREERS
ABOUT ABBOTT
WE’RE DEVELOPING TECHNOLOGIES, EXPANDING ACCESS AND SHARING RESOURCES AS PART OF OUR EFFORTS TO LIMIT THE CORONAVIRUS
We are working across our company and in partnership with others to support communities worldwide with resources and technologies to fight this evolving threat. Getting new tests into the hands of frontline workers so people can receive the critical results they need. Ensuring continued access to medical devices, diagnostics, medicines and nutrition products without disruption. And supporting those affected by the pandemic. Until this fight is over, we will never quit.
Learn more about our efforts to tackle the coronavirus.
Testing is a critical part of addressing this threat. It's a battle that is fought on multiple fronts, from physicians' offices and urgent care clinics to hospitals and molecular labs, from emergency departments to those hotspots where help is needed most.
Under FDA emergency use authorization (EUA), we are distributing five COVID-19 tests. For molecular testing, our rapid, point-of-care COVID-19 tests for our ID NOW system, our m2000 RealTime molecular laboratory test as well as our Alinity m platform. For antibody testing, our blood test that runs on the ARCHITECT i1000SR and i2000SR laboratory instruments as well as the Alinity i.
Diagnostic testing is key to solving the complex puzzle of an infectious disease outbreak, by helping slow the spread of the virus. The Abbott RealTime SARS-CoV-2 test runs on our m2000 RealTime systems, which are already located in hospital and academic medical center labs and reference laboratories in the U.S. The FDA also granted an EUA to Alinity m molecular testing for COVID-19, expanding speed and efficiency on a machine that can run up to 1,080 tests in 24 hours. These high-volume platforms help healthcare providers meet the unprecedented demand for testing.
Learn more about Abbott's m2000 platform.
Learn more about Abbott's Alinity m platform.
Abbott’s ID NOW COVID-19 test is a vital weapon in this battle. It is a fast, molecular point-of-care test, one that can deliver results in as little as 5 minutes. Just as importantly, it can take portable testing outside of a traditional hospital and into physicians’ offices, urgent care clinics and other point-of-care settings.
Learn more about Abbott’s ID NOW platform.
Our antibody tests can help play a role in the next step of fighting the COVID-19 pandemic head-on. Antibody tests determine if someone was exposed or infected. The body produces IgG antibodies in the late stages of infection and can remain for months or even years after recovery. Our IgG antibody test are available on ARCHITECT i1000SR, i2000SR and Alinity i laboratory instruments.
Learn more about Abbott's ARCHITECT platform.
Learn more about Abbott's Alinity i platform.
Find answers to frequently asked questions about Abbott's COVID-19 tests.
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.
The SARS-CoV-2 IgG assay has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of the IgG antibody against 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.
The Abbott RealTime SARS-CoV-2 assay and the Alinity m SARS-CoV-2 assay have not been FDA cleared or approved. These tests have been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories. These tests have been authorized only for the detection of nucleic acid 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 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.
Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. The website you have requested also may not be optimized for your specific screen size.
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.