Health Canada approves certain serology testing for doctor-use only
By GILLIAN SLADE on July 4, 2020.
gslade@medicinehatnews.com@MHNGillianSlade Although Alberta Health will not be offering the general public the option of serology testing, Health Canada has approved some tests for use by doctors. “Authorized testing devices for COVID-19 that indicate point of care could be used by doctors to test their patients in their office,” said Geoffroy Legault-Thivierge, spokesperson for Health Canada. Health Canada’s website indicates two tests have already been approved for “point of care” testing. https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/authorized/list.html#wb-auto-5 Serology testing is not used to detect if someone has COVID-19 but rather the presence of antibodies that could indicate whether someone previously had COVID-19. On May 2 the Spartan Cube COVID-19 system by Spartan Bioscience Inc. Canada was approved using nucleic acid technology. On March 24 the Xpert Express SARS-CoV-2 by Cepheid in the U.S. using nucleic acid technology was approved. Legault-Thivierige says companies are the ones who specify whether their device is intended for laboratory use only, or for point of care testing in their application. Health Canada is not involved in that aspect. About 11 applications with Health Canada are in process for approval for “point of care” testing. The full list can be seen on this website: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing/applications.html#wb-auto-5 The News has been unable to determine if there are any pharmacists or doctors in Medicine Hat currently offering serology testing or whether it is an initiative that is planned. If you offer this please email: gslade@medicinehatnews.com On June 23 Alberta Health announced an investment of $10 million for serology testing in Alberta. It would be limited to four specific research studies to learn more about the virus and monitor the spread. There are two pediatric studies in Calgary and Edmonton that will continue for a couple of years. Another will test samples of blood collected for other purposes and the fourth will test select Albertans more than 45 years old to determine who was exposed to COVID-19. If a serology test done on blood collected for another purpose is positive, the person whose blood that was will not be told. The tests for those more than 45 years old will only apply to people in Edmonton, Calgary, Red Deer and Lethbridge who are already enrolled in the Alberta’s Tomorrow Project (ATP) that was launched in 2000. ATP is a study tracking the health of 55,000 adults in Alberta. Only some of the participants in ATP will be tested every four months, for at least a year, to estimate the number of Albertans who have been exposed to COVID-19 and follow the trend over time. The serology testing will not differentiate between a COVID infection that occurred after COVID-19 tests were introduced in March and those who may have had it before that point. 16-15
