Health Canada has received submissions for two types of in vitro diagnostic testing devices:
- nucleic acid-based tests (detection of the virus)
- serological-based tests (detection of antibodies)
Health Canada has posted to their website that they are “not aware of a serological-based test that has been validated for diagnosis of COVID-19 to date. However, serological tests will play an important role in an overall testing strategy for Canada as they will provide evidence in assessing the true extent of COVID-19 in the general population.” “Health Canada is actively assessing a number of applications for serological tests that are supported by appropriate evidence. ” And this is where our test waits, along with others while Health Canada sorts through mountains of data to see if the manufacturers of these products have done enough independent testing to determine the reliability of the test before they release it for public use.
We see more and more countries in the news returning antibody tests (UK) or cancelling orders (India) because the tests, which in these cases were manufactured in China, were too unreliable. Several nations have questioned the effectiveness of coronavirus antibody tests and other medical equipment obtained from Chinese companies, including Turkey, Spain, the Netherlands, and the Czech Republic. Around the world countries are desperate for options and need answers so that they can get people back to work and some for of normalcy.
The popular idea is that we use these tests to determine if you have a past infection which it is suggested may give you some immunity. And so far, researchers say they have not seen any evidence that people can get reinfected with the virus, but there is so much we still don’t know.
For now we wait while Health Canada continues to review the data needed to have faith a test will be able to detect antibodies to COVID-19 with accuracy.
Once we have the test the next question will be how will they let us use it?
