YOUR COVID-19 TESTING QUESTIONS

Last Updated: AUG 26, 2020

WHAT TESTS DO YOU HAVE FOR DETECTING COVID-19?

We have developed six tests for COVID-19. We have three molecular tests and one antigen test that help detect an active infection of COVID-19, as well as 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://abbo.tt/2U1WMiU

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://abbo.tt/2zrt52N

Our rapid, molecular point-of-care test detects COVID-19 in 13 minutes or less. This test is used on our ID NOW instrument. For more information on ID NOW check out this article: https://abbo.tt/2UT36cN

Our rapid antigen test, BinaxNOW COVID-19 Ag Card provides results in 15 minutes. The test does not need any additional equipment and can be performed by healthcare professionals at the point-of-care, making it an important tool to diagnose COVID-19. The test was also designed to pair with our optional mobile app for iPhone and Android devices, NAVICA. The first-of-its-kind app, available at no charge, will allow people who test negative to get a temporary digital health pass that's renewed each time the person has negative test. Test results are encrypted and are available only to you and those you choose to share them with. Organizations like employers and schools will have the option to use the app to view and verify the information on a mobile device to facilitate safer entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.

For more information on BinaxNOW COVID-19 Ag Card and NAVICA check out this news release.

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://abbo.tt/3abd0eq
For more information on the Alinity i system, check out this news release: https://abbo.tt/2SWCvtU

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.

BinaxNOW COVID-19 Ag Card is also a rapid test. It is used by healthcare professionals for the detection of antigens that form in the early stage of active infections. The test is highly portable (about the size of a credit card), affordable, and provides results in 15 minutes.

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 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.

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.

Antigen testing: 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 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://abbo.tt/3b8bASF

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://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://abbo.tt/33SG3Sn

BinaxNOW COVID-19 Ag Card provides results in 15 minutes. Learn more about COVID-19 testing on BinaxNOW COVID-19 Ag Card here.

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://abbo.tt/3abd0eq

Learn more about Alinity i here: https://abbo.tt/2SWCvtU

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 six of our tests met all testing criteria under the FDA's emergency use authorization (EUA) 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 six platforms and ship to more customers, helping healthcare providers on the front lines battle this pandemic.

Check out our most recent progress update: https://abbo.tt/3aFeePW

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 has launched 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.

Find where Abbott's COVID-19 antibody testing is available in the U.S.

The BinaxNOW COVID-19 Ag Card is available in the U.S.

Check with your local healthcare provider if you have questions about availability in your area.

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 BinaxNOW COVID-19 Ag Card: https://abbo.tt/2Qk76jp

For general questions about ID NOW: https://abbo.tt/2P8bYru

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

IS MY INFORMATION SECURE WHEN USING THE NAVICA MOBILE APP?

Yes. Data transmitted in the app is encrypted and users only share name, birthdate, phone number, zip code and email address which is used for creating your personal profile in the app.

WILL YOUR RAPID TEST BE AVAILABLE IN DRIVE-THRUS?

Select CVS and Walgreens are using ID NOW 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. Given its size and speed, BinaxNOW COVID-19 Ag test could be used in drive-thrus as well as many other settings where people gather.

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

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://abbo.tt/3hJSINd

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/2UT36cN
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

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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