Abbott Announces Health Canada Authorization Under the COVID-19 Interim Order and Immediate Availability of its COVID-19 Antibody Test in Canada

Via Abbott

Abbott (NYSE: ABT) announced today it received Health Canada authorization under the COVID-19 Interim Order* for the ARCHITECT SARS-CoV-2 IgG test, a laboratory-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19). Antibody testing is an important next 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 and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines.

This antibody test adds to Abbott’s existing COVID-19 tests in Canada that are already being used on its m2000™ molecular laboratory system.

“Abbott has been singularly focused on bringing COVID-19 tests to market as quickly as possible to help address this pandemic,” said John Simmons, General Manager, Canada, Diagnostics, Abbott. “We are proud to be providing our antibody tests as they will help understand who has had the virus, leading to greater confidence as we get back to living life.”

Antibody tests to expand testing
While molecular testing detects whether someone has the virus, antibody tests determine if someone was infected. Abbott’s SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and may remain up to months and possibly years after a person has recovered. The test demonstrated specificity and sensitivity to detect IgG antibodies of greater than 99 per cent 14 days or more after symptoms started.

Our contributions to bring broad scale access to reliable testing
As a leader in infectious disease testing, Abbott’s goal is to bring highly reliable tests for customers and patients around the world. Since the test became available, leading virology labs around the world have validated the test and demonstrated its high performance.

A recent study published in the Journal of Clinical Microbiology found that Abbott’s SARS-CoV-2 IgG antibody test had 99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients 17 days or more after symptoms began.

Abbott’s IgG antibody test will initially be available on its ARCHITECT® i1000SR and i2000SR laboratory instruments.** ARCHITECT is one of the most widely used laboratory systems in the world and it has been used for decades with a large installation base in laboratories throughout Canada. These instruments can run up to 100-200 tests per hour. 

Abbott is significantly scaling up its global manufacturing for antibody testing and will expand testing to its Alinity™ i system. Abbott will also be expanding its laboratory antibody testing to the detection of the antibody, IgM, in the near future.

About Abbott’s Diagnostics Leadership
Abbott has long been a global leader in infectious disease testing, including the development of the first HIV test. The company created a Global Surveillance Program 25 years ago to monitor HIV and hepatitis viruses and identify mutations to ensure the company’s tests remain up to date. Abbott also has a long-standing discovery program that identifies new or unknown pathogens and develops tests to address these new threats.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

* Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.
** All ARCHITECT analyzers are Class 1 laser products.

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