PRODUCTS & INNOVATION
COVID-19: THE DIFFERENT TESTS EXPLAINED
A mix of antigen, molecular and serology tests will help curb the COVID-19 pandemic.
Aug 26 2020
Test. Test. Test. It's key to beating the coronavirus pandemic, according to the World Health Organization.
That's why Abbott is leveraging our diagnostics leadership and developing more tests on more platforms, to help test millions of people around the world for COVID-19.
Abbott has currently developed six COVID-19 tests — three are molecular (they detect the virus during active infection), one is an antigen test (identifying COVID-19 mid-infection as the virus multiplies) and two are serology tests (they identify IgG antibodies, proteins the body produces in the late stages of infection, which may remain in the blood for months and possibly longer after a person has recovered.)
All of our tests have been approved by the U.S. Food and Drug Administration for Emergency Use Authorization.
And among our test types — antigen, molecular and serology — there are rapid tests that can be performed at the point of care (think urgent care clinics and doctors' offices) and tests that run on large, high-volume lab instruments found in hospitals and academic centers, which assess hundreds of samples at a time.
Each of our tests plays a role in helping frontline workers diagnose COVID-19 and better understand it.
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To help frontline workers identify people infected with COVID-19, Abbott launched two lab-based molecular tests, which are used on our m2000 RealTime system (available in hospitals and molecular labs around the world) and our new Alinity m system. In a 24-hour period, the Alinity m system can run up to 1,080 tests and our m2000 system up to 470 tests
For situations where a fast portable test is needed, Abbott developed a molecular point-of-care test that runs on our ID NOW system, which is the size of a small toaster. The test delivers results in 13 minutes or less.
The molecular tests use an upper respiratory tract swab to collect a mucus sample. Our ID NOW system can also use a throat swab.
As the virus begins multiplying, antigens (proteins on the outside of the virus) can be detected. Abbott's BinaxNOW™ COVID-19 Ag Card test can identify these antigens, which are typically detected after symptoms start. Results from the simple nasal swab are available in 15 minutes through a healthcare provider. The BinaxNOW-19 Ag Card is highly portable, easy-to-use and affordable, making it a valuable tool for helping reduce disease spread.
The test pairs with our first-of-its-kind app named NAVICA™, which works on iPhone and Android devices. The optional app, available at no charge, will allow people who test negative for COVID-19 to get a temporary encrypted digital health pass with a QR code. The health pass will be renewed each time a person takes a new test and will include the date of the latest test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.
An important next step in diagnosing COVID-19 is serology tests, also called antibody tests, which can help tell if someone has been previously infected. This type of knowledge will enable scientists to better understand how long these antibodies stay in the body and if they provide immunity. This information can also help public health officials understand how widespread the outbreak is and could help support the development of treatments and vaccines for COVID-19.
Abbott's lab-based serology tests detect the IgG antibody to SARS-CoV-2 in the blood and run on our Alinity i system as well as on our ARCHITECT i1000SR and i2000SR instruments. Both Alinity i and our ARCHITECT instruments can run up to 100-200 tests an hour.1
"Testing across different platforms and settings is extremely helpful in our fight against COVID-19 to keep people healthy as we continue to flatten the curve and look for new ways to safely reopen the country," said Dr. Robert Hart, Executive Vice President and Chief Medical Officer, Ochsner Health, Louisiana.
"Molecular testing has been valuable in determining who has the active infection and how to help stop the virus from spreading," Dr. Hart said. "The new serology tests can help public health officials and policymakers make critical decisions based on how prevalent the virus is in their community."
1. All ARCHITECT analyzers are Class 1 laser products.
This story was originally published on June 22, 2020. It was updated on August 26 to include reference to our announcement on Abbott’s launch of its sixth COVID-19 test, a rapid antigen test, and a companion mobile app.
The BinaxNOW™ COVID-19 Ag Card 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. The test has been authorized only for the detection of proteins 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 following tests have received FDA Emergency Use Authorization and have not been FDA cleared or approved: RealTime SARS-CoV- test, ID NOW COVID-19 test, SARS-CoV-2 IgG assay for use on ARCHITECT and Alinity i, and Alinity m and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro tests for detection and/or diagnosis of COVID-19, not for any other viruses or pathogens,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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