The NRC's spike protein reference material is now available for the Canadian research community.
A massive international movement to develop tests, therapeutics and vaccines aims to conquer coronavirus disease (COVID-19). But these efforts have been restricted by the challenge of finding appropriate raw material reference tools to enable consistent testing. Fortunately, a made-in-Canada solution is supplying the R&D community with the answer: characterized antigen testing materials.
Images of round virus particles covered in spiky bumps have blanketed the media since the SARS-CoV-2 virus was identified in early 2020. Those spikes—proteins that bind the virus onto human cells to infect them—are a critical ingredient for helping researchers better understand and eliminate COVID-19. They can be useful in many different ways—from the development of COVID-19 vaccines to diagnostic testing.
Spike proteins can be particularly useful for serological testing, which shows whether individuals have developed an immune response to SARS-CoV-2, and uncovers the true extent of infections in the general population. This information can help scientists identify people who must be vaccinated, and analyze the effectiveness of existing and future vaccines.
However, spike proteins are technically challenging to produce, and sourcing sufficient quantities of this type of reagent is complex, expensive and time-consuming. So, in the race to develop tests and vaccines at unprecedented speed, labs around the world are turning to external suppliers for SARS-CoV-2 spike proteins.
The challenge lies in the variety of production platforms among manufacturers, meaning the composition and quality of their proteins are inconsistent. This affects the value and accuracy of lab tests, and complicates the comparability of test results.
A made-in-Canada solution
The good news is that the National Research Council of Canada (NRC) has released a standardized spike protein reagent that is available to labs developing serological tests, vaccines or therapeutics to treat COVID-19. "We are the first organization to distribute this type of reference material," says Dr. Yves Durocher, NRC Research Officer, Human Health Therapeutics Research Centre. "This high-quality spike protein antigen is now available and can be used for COVID-19 R&D, testing and vaccine development."
Dr. Durocher, a leading expert in the biomanufacturing of complex recombinant proteins, worked closely with his counterpart at the NRC's Metrology Research Centre, Team Lead Dr. Jeremy Melanson, who is a foremost authority in analytics and certified reference materials. Their combined efforts were key to establishing this reagent as a reference material for labs working with COVID-19 R&D, sero-surveillance and vaccine development.
"The NRC's Metrology Research Centre, through its national mandate to produce certified reference materials, has been supporting measurement accuracy in the food safety and environmental testing sectors for decades, says Dr. Melanson. "Conducting measurements such as determining exact amounts of the spike protein antigen and rigorous stability testing required to develop the spike protein reference material was a natural extension of these efforts."
Canadian R&D community confirms the NRC's reagents provide test accuracy
Dr. Durocher says the NRC has worked hard to ensure the reagents are consistent. "Because we have established robust production and purification processes and firm quality standards for these raw materials," he says. "We can meet the high demand for reference material samples by producing large batches with consistent quality."
Various academic, government and private labs are already using the NRC's spike antigen and other NRC-made reagents to develop Canadian serology testing assays, including running tens of thousands of serological tests in robotized automated assays using the NRC's reagents.
Spreading Canadian solutions around the world
Funded by the Government of Canada and driven by the NRC's Pandemic Response Challenge program, this research illustrates the impact that made-in-Canada solutions can have on the world. The program brings together the best Canadian and international researchers to fast-track R&D aimed at specific COVID-19 gaps and challenges identified by Canada's health experts.
"We are now in a position to pursue additional opportunities to distribute the antigen to a wider range of organizations for research purposes," says Dr. Melanson. "Using standardized research materials will lead to greater harmonization in testing in Canada and hopefully internationally."
Researching solutions for the future
While the availability of vaccines is a major breakthrough, much research on COVID-19 remains to be done. Sero-surveillance work on vaccine effectiveness, stability and longevity will be ongoing—and the findings will contribute critical intelligence for developing next-generation vaccines and dealing with future pandemics.
For the moment, the NRC is only offering the SARS-CoV-2 spike protein, but researchers are also making other reagents which may become available for the R&D community in the future. These include detection antibodies, positive control anti-spike antibody, nucleocapsid and the ACE2 receptor, which is the entry door for the virus to infect human cells.