As the demand for blood tests that can reveal who may have been exposed to COVID-19 coronavirus is increasing, researchers at the Lunaifeld-Tanenbaum Research Institute at Sinai Health in Toronto are adapting a robotic system to process these tests on a large scale.
If enough samples can be collected, the platform could offer the quickest way to answer key questions about the extent of the pandemic in Canada and potentially determine who is already immunized against the new coronavirus after only having one case mild or asymptomatic of COVID -19.
“We could analyze 10,000 samples a day,” said Anne-Claude Gingras, principal investigator at the institute and co-responsible for the effort. “So that would really allow us to profile a large number of patients. “
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Dr. Gingras added that the ability to handle so many tests at a time would also allow testing a sample from a single patient multiple times, which would give more confidence in the result than what could be obtained with a test kit. single use commercial.
The need for more testing capacity has been an issue since cases of COVID-19 began to appear in large numbers in Canada. In general, higher priority has been given to tests that can determine whether a person is actively infected with the coronavirus and therefore likely to be infectious due to the presence of viral genetic material in the patient’s samples.
But health officials and epidemiologists say there is also an increasing requirement for serological tests that only require a drop of blood and that can reveal whether someone has had COVID-19 at any time in the past. These types of tests are sensitive to the antibodies that the immune system produces in response to a viral attack, which should persist for several months after the virus itself has been cleared from the body.
If made both reliable and widely available, these tests could be used to identify who has had the coronavirus before. The test may also indicate that a person is immune to the coronavirus, but it depends on whether the antibodies detected are an effective deterrent against reinfection. In this case, large-scale tests would provide information on the development of the level of immunity in the general population.
“We want to measure, with thousands of samples, what happens over time,” said Jim Woodgett, director of the institute.
The arrival of the new platform could prove to be crucial as efforts to make commercial serological tests more widely available in Canada remain within a regulatory framework.
At the last count, Health Canada received 16 requests from companies seeking approval for serological testing, but none has yet been reviewed.
Vivian Zhang, sales specialist with one of the applicants, Biogate Laboratories Ltd. of Burnaby, BC, said the company is hoping for approval of its Canadian-made serology test that provides a simple yes or no to the presence of antibodies in five to 10 minutes. The test can be used either by individual consumers, or by health clinics and laboratories.
She added that the company is now providing additional information in response to questions from Health Canada.
“We hope Health Canada can approve it as soon as possible, as the situation in Canada continues to be urgent,” said Ms. Zhang.
In a news release, Health Canada said it is working with researchers at the National Microbiology Laboratory in Winnipeg, among others, “so that we can have confidence in the test results.”
Serological tests are currently used in China and Singapore. On Thursday, the U.S. Food and Drug Administration approved a serological test by Cellex, a biotech company based in North Carolina, for use in the U.S.
Where Sinai’s health effort differs from commercial test providers, it is in its potential to provide a view of infection rates in a large group of subjects over time. Because it uses a robotic system, it can provide uniform sample handling and quality control while reducing the supplies and staff resources required to study a large group of subjects.
The most important raw material on the platform is a large amount of coronavirus proteins, which are used to detect the presence of COVID-19 antibodies in blood samples. The proteins were purified by University of Toronto biochemist James Rini, who specializes in coronaviruses.
Dr. Gingras said she hopes the robotic system will be used first in a cohort study of health workers in the Toronto area organized by the University Health Network. Known as the RESPECT study, the goal of the project is to detect asymptomatic cases of COVID-19 in a population of around 3,000 health workers, many of whom are very likely to have been exposed to the virus.
Deepali Kumar, a clinician at the Research Institute at the Toronto General Hospital, said that serological tests would provide valuable information for the study and provide some assurance to those wondering if they were at risk of contracting the virus.
“I think if we could tell the health workers that they have antibodies and therefore have already been exposed, it could reassure them that they will not bring a virus home,” said Dr. Kumar.
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