Abbott (NYSE:ABT) announced today that Health Canada has granted interim authorization for its Architect SARS-CoV-2 IgG serology test for COVID-19.
The Abbott Park, Ill.-based company won an FDA emergency use authorization and the CE Mark for the same antibody test for use on its Architect system in April. The test is designed to detect the IgG antibody, a protein that the body produces in the late stages of infection and may remain up to months after a person has recovered from the novel coronavirus.
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 has come under scrutiny for the accuracy of one of its COVID-19 molecular diagnostic tests.
The company said it expects to begin shipping antibody tests to Canada this week and intends to distribute 30 million tests globally by the end of June. The company is already selling COVID-19 diagnostic tests for use on its m2000 molecular laboratory system in Canada and plans to expand the IgG test’s use on its Alinity i laboratory system there as well.
“Abbott has been singularly focused on bringing COVID-19 tests to market as quickly as possible to help address this pandemic,” said John Simmons, Abbott’s GM for diagnostics in Canada, in a news release. “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.”
Abbott’s IgG antibody test will initially be available on its Architect i1000SR and i2000SR laboratory instruments, which can run up to 100-200 tests per hour, according to the company.