A point-of-care diagnostic tool that provides accurate, fast and inexpensive screening tests in support of the global effort to mitigate the effects of the COVID-19 outbreak will save lives, said a University of Alberta analytical and environmental toxicology researcher who won a grant to develop just such a tool.
"We have already started with the development," said Chris Le, a professor in the Department of Laboratory Medicine and Pathology who is leading one of four U of A projects funded through the Canadian Institutes of Health Research (CIHR) Rapid Research Funding Opportunity created to aid in the battle against COVID-19.
"The inability to complete rapid screening and early diagnosis significantly hinders the global efforts to effectively contain and mitigate the spread of COVID-19.
"We think we will have the first diagnostic tool within one to three months."
Short of a vaccine or a cure, Le said, a point-of-care medical countermeasure is the most pressing need in the race to stop the marauding virus with a death rate estimated to be three per cent, and reaching double digits for the elderly.
Current tests require precisely controlled temperature, specialized instrumentation, trained technical personnel and specialized laboratory settings. A diagnosis requires that technicians deactivate the virus, extract its RNA from the sample and then perform a reverse transcription, which means transcribing RNA into DNA. And then, because the virus that causes COVID-19, known as SARS-CoV-2, congregates in the lower respiratory system and there aren't always a lot of viral particles available in the swab, another process that amplifies the DNA is necessary.
The tediousness and multiple steps involved in the current protocol mean that these tests suffer from false-negative rates as high as 50 per cent.
"Identifying those who are true positive and being ready with appropriate countermeasures early is of the utmost importance," said Le.
Le said his team's goal is to come up with a pair of tests: one in which the chemical reactions needed for efficient amplification and sensitive detection of the viral RNA take place in a single test tube at a moderate temperature, simplifying the operation procedures; and another similar to a pregnancy test, in which changes on a paper strip indicate the presence of the virus.
"The specific reaction products are visible to the naked eye, thus eliminating the need for any elaborate equipment in resource-limited settings," said Le. "It should also cut the process from four hours to one."
Once they have a prototype and the regulatory requirements have been met, Le said testing will begin with their collaborator teams in Wuhan. Once validated and approved, the new diagnostic tools will be used to support screening and diagnosis of COVID-19 at the community level. The mid-term objective also includes adapting the point-of-care diagnostics at other collaborating sites in Pakistan and Kenya.
Le said the expedited process-from starting research to applying for the grant-has required a Herculean effort from his team of researchers, as well as a legion of co-applicants that includes top U of A virologists, chemists, infectious disease specialists, front-line practitioners and public health researchers, as well as scientists from the Canadian Food Inspection Agency and Wuhan Institute of Virology.
CIHR grant recipients from U of A
Chris Le, Faculty of Medicine & Dentistry
Point-of-care diagnostics of COVID-19 using isothermal amplification and CRISPR technology
$828,046
Joanne Lemieux, Faculty of Medicine & Dentistry
Structural studies and evaluation of inhibitors of the 3CL protease of SARSCoV-2 as potential drugs for treating infection
$714,250
Matthias Götte, Faculty of Medicine & Dentistry
Development and evaluation of SARSCoV-2 RNA polymerase inhibitors
$675,000
Kimberly Noels, Faculty of Arts
Chinese and non-Chinese Canadians' response to the 2019 novel coronavirus (COVID-19): Interrelations between risk perception, discrimination, and preventative health actions
$219,580