YOUR COVID-19 TESTING QUESTIONS

Last Updated: May 21, 2020

WHAT TESTS DO YOU HAVE FOR DETECTING COVID-19?

We have developed five tests for COVID-19. We have three molecular tests that help detect an active infection of COVID-19 and two serology tests that help detect antibodies. Our first molecular test is used on our lab-based molecular instrument, m2000. Many of these instruments are already located in hospital and academic medical center labs where patients go for care. For more information on m2000, check out this article: https://www.abbott.com/corpnewsroom/product-and-innovation/abbott-launches-novel-coronavirus-test.html

We also have a molecular test for our Alinity m system under the FDA's Emergency Use Authorization. For more information on Alinity m, check out this news release: https://abbott.mediaroom.com/2020-05-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-COVID-19-Molecular-Test-on-New-Alinity-TM-m-System

Our rapid, molecular point-of-care test detects COVID-19 in as little as 5 minutes, with negative results in 13 minutes. This test is used on our ID NOW platform. For more information on ID NOW check out this article: https://www.abbott.com/corpnewsroom/product-and-innovation/detect-covid-19-in-as-little-as-5-minutes.html

Our two lab-based serology blood tests are used for the detection of the antibody, IgG, that identifies if a person has been previously exposed to the virus that causes COVID-19. The tests are available on our ARCHITECT and Alinity i systems.

For more information on our ARCHITECT antibody test, check out this article: https://www.abbott.com/corpnewsroom/product-and-innovation/abbott-launches-covid-19-antibody-test.html
For more information on the Alinity i system, check out this news release: https://abbott.mediaroom.com/2020-05-11-Abbott-Receives-FDA-Emergency-Use-Authorization-for-COVID-19-Antibody-Blood-Test-on-Alinity-TM-i-System

HOW ARE THE TESTS DIFFERENT?

There are a variety of different tests being deployed and a whole ecosystem is needed to support testing in different healthcare settings. Our m2000 and Alinity m molecular systems are used in hospital and lab settings that are testing high volumes. ID NOW is a lightweight and portable instrument (the size of a toaster), that allows testing to occur near the patient to get rapid results – including physicians’ offices, urgent care settings and hospital emergency departments.

Our lab serology blood tests running on ARCHITECT and Alinity i systems are used for the detection of the antibody, IgG, and identify if a person was previously infected with the virus that causes COVID-19. An antibody is a protein that the body produces in the late stages of infection and may remain for up to months and possibly longer after a person has recovered.

WHAT IS ANTIBODY TESTING?

Antibody testing is an important step to tell if someone has been previously infected. It will provide more understanding of the virus, including how long antibodies stay in the body. This type of knowledge could help support the development of treatments and vaccines.

HOW WERE YOU ABLE TO DEVELOP TESTS SO QUICKLY?

Abbott has been a global leader in infectious disease testing for decades, having developed the world's first HIV test. We created a Global Surveillance Program 25 years ago to monitor HIV and hepatitis viruses and have a long-standing discovery program to identify new or unknown pathogens. While developing an accurate and reliable test normally takes years, our expert team of scientists worked around the clock to compress the timeframe down to weeks. Our tests are all important tools in the broader comprehensive testing effort.

HOW DO YOUR TESTS WORK?

Molecular testing: Take a look at this infographic on how coronavirus molecular testing works. This how-to video also helps explain how molecular point-of-care testing on ID NOW works.

Serology testing: For more information on how testing for antibodies works, check out this infographic.

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

Molecular tests that run on our m2000 system are already located in hospital and academic medical center labs, and reference laboratories, where patients are presenting for care. This allows for fast test results since they don’t need to be sent out. The systems have the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing. Learn more about m2000 here: https://abbott.mediaroom.com/2020-03-18-Abbott-Receives-FDA-Emergency-Use-Authorization-and-Launches-Test-to-Detect-Novel-Coronavirus

Alinity m systems have the ability to run high volumes of up to 1,080 tests in 24 hours, helping to meet the increasing demand for testing. Learn more about Alinity m here: https://abbott.mediaroom.com/2020-05-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-COVID-19-Molecular-Test-on-New-Alinity-TM-m-System

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://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes

Our serology test on the ARCHITECT and Alinity i systems can run up to 100-200 tests per hour. Learn more about ARCHITECT here: https://www.abbott.com/corpnewsroom/product-and-innovation/abbott-launches-covid-19-antibody-test.html

Learn more about Alinity i here: https://abbott.mediaroom.com/2020-05-11-Abbott-Receives-FDA-Emergency-Use-Authorization-for-COVID-19-Antibody-Blood-Test-on-Alinity-TM-i-System

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 five of our tests met all testing criteria in the FDA's emergency use authorization (EUA) guidance and we’re continuing to collect more data in the field.

HOW MANY TESTS ARE YOU MAKING?

We continue to ramp up production of our COVID-19 tests across our four platforms and ship to more customers, helping healthcare providers on the front lines battle this pandemic.

Check out our most recent progress update:
https://www.abbott.com/corpnewsroom/product-and-innovation/an-update-on-abbotts-work-on-COVID-19-testing.html

WHERE ARE YOUR TESTS AVAILABLE?

Currently, the ID NOW COVID-19 test is available only in the U.S. as this is where the majority of our ID NOW instruments are in use today. We’re also supplying our m2000 tests in the U.S., and are shipping as many tests as possible to customers around the world. Our Alinity m test is launching in the U.S.

Our antibody tests for ARCHITECT and Alinity i systems have received both Emergency Use Authorization in the U.S. and CE Mark in Europe.

HOW CAN TESTS BE ACCESSED?

If you are an individual, please reach out to your healthcare provider. If you're with a hospital, lab or healthcare provider, please see the contact details below.

For general questions about ID NOW: https://www.alere.com/en/home/product-details/id-now-covid-19.html

For general questions about m2000: https://www.molecular.abbott/us/en/knowledge-center/support

For general questions about ARCHITECT: https://www.corelaboratory.abbott/us/en/offerings/segments/infectious-disease/sars-cov-2

For general questions about Alinity i: https://www.corelaboratory.abbott/int/en/offerings/brands/alinity

For general questions about Alinity m: https://www.molecular.abbott/us/en/products/instrumentation/alinity-m-instrument

WILL THE ID NOW RAPID TEST BE AVAILABLE IN DRIVE-THRUS?

Select CVS and Walgreens recently began using our test in drive-thru settings in the U.S. For more information please check with your local CVS or Walgreens for more details on available testing locations.

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://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

HOW DO I KNOW IF I NEED TO SEEK OUT ONE OF YOUR TESTS?

Please check the CDC resources on how to protect yourself and what to do if you think you are sick: https://www.cdc.gov/coronavirus/2019-ncov/index.html

LOOKING FOR MORE INFO? CHECK OUT THESE HELPFUL LINKS.

true
accessibility

You are about to exit for another Abbott country or region specific website

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.

Do you wish to continue and exit this website?

accessibility

You are about to exit the Abbott family of websites for a 3rd party website

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.

Do you wish to continue and exit this website?