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

Abbott announced on May 21 that 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."

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.

  • New antibody blood test will run on Abbott's ARCHITECT® i1000SR and i2000SR laboratory-based instruments and will expand to its Alinity™ i system.
  • Abbott expects to begin shipping antibody tests to Canada this week and intends to distribute 30 million tests globally by the end of June. Abbott is already providing its COVID-19 molecular test for its m2000™ instrument in Canada.
  • Test demonstrated specificity and sensitivity of greater than 99% 14 days or more after symptoms started.

— Abbott

— AB

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