NEW YORK – Abbott Laboratories announced Thursday that its Architect SARS-CoV-2 IgG antibody test received Health Canada authorization and that it will begin shipping antibody tests to Canada this week.
The serology blood test detects IgG antibodies that identify whether a patient has had COVID-19 and runs on Abbott's Architect i1000SR and i2000SR instruments, which can run up to 100 to 200 tests an hour. The test will expand to the Alinity i system and Abbott hopes to expand serology testing to include testing for IgM antibodies in the future, the firm said.
Abbott added that it expects to start shipping antibody tests to Canada this week, distributing 30 million tests globally by the end of June. Abbott's molecular test that runs on its m2000 instrument is already being used in Canada and received Health Canada authorization in April.
The antibody test received Emergency Use Authorization from the US Food and Drug Administration last month.
Abbott's test demonstrated specificity and sensitivity greater than 99 percent two weeks or more after symptoms started, according to the Abbott Park, Illinois-based company. However, a recent study from Washington University in St. Louis found the test's sensitivity to be 94 percent after two weeks.