Sep 23, 2021

About the author

Michelle Zaharik, PhD

Dr. Michelle Zaharik, PhD, is an accomplished Research and Development professional with 15+ years of experience in the design and management of R&D, Clinical and Regulatory paths for In Vitro Diagnostic devices. 

Topic tags

Covid-19, PoC, Diagnostics

Point of Care Testing in Canada – Time for Consensus

Listening to recent discussions in the media on point of care testing (POCT) as a tool to help manage the COVID-19 pandemic one would think that POCT is new to the diagnostic scene. However, nothing could be further from the truth -   as a member of the Canadian diagnostics community focused on POC development and delivery for the last 15 years I have witnessed firsthand the ongoing fight for visibility and recognition of POCT in general and in Canada in particular. While I am excited to see the recent acceptance of the value of COVID-19 POCT programs, we must be looking towards how best to implement and utilize POCT in Canada beyond the pandemic. 

POCT represents testing performed at the bedside or near the patient with rapid availability of results (within minutes to a couple of hours) that enables immediate and informed decisions about patient care. This testing is commonly used at sites with limited laboratory infrastructure as an alternative to having to send a blood sample to a laboratory and waiting for test results or having to send a patient to the nearest urban center for urgent treatment. POCT has multiple advantages over conventional testing including being supportive of increased staff and patient mobility, portability across community and rural settings, and rapid turnaround time of test results, all of which may expedite decision-making and patient management and increase efficiency of care.  Given the vast Canadian geography and the challenges involved in delivering quality healthcare to rural and remote communities, one would think that the availability of POCT would be high. Yet as this pandemic has shown, the recognition of the value of POCT and the ability to roll out POCT programs has been painfully slow.

Healthcare systems are not known to be quick to take advantage of innovative technologies that can impact quality of care. The time and energy required to cut through multiple levels of bureaucracy, resistance to change, and implementation costs are all known challenges for new technology adoption. Further barriers specific to the adoption of POCT in Canada include challenges in getting regulatory approvals for POC tests, but even once approval has been obtained inconsistency in requirements for implementation and oversight of POCT programs across the country has stymied POCT uptake. 

Historically POCT programs have been handled differently province by province – for example Ontario allows POCT programs to be operated via medical directive (an indirect order approved by a responsible physician to give authority to a care provider to implement the order on a specific patient population [1]) while BC requires sites running POCT to either be under the supervision of a central lab or to obtain accreditation via the Diagnostic Accreditation Program (DAP) through the College of Physicians and Surgeons of BC [2]. The requirements for the latter are stringent and intimidating to navigate for those who are unfamiliar with the traditional laboratory testing environment, to say the least. Further, despite POC tests in Canada being licensed for use by non-laboratorians/peer operators, most provinces still adhere to legacy policies that mandate that only “regulated health care professionals” can administer POCT [3] which leads to confusion and limitations on POCT program staffing and represents an additional roadblock to implementation.

Now in these COVID times instead of requirements for POCT getting more streamlined they are getting more inconsistent. Notably in BC two separate programs for COVID-19 POCT now exist:  fee-for-service POCT, be it RT-PCR, antigen or antibody testing for any purpose, requires full independent accreditation through the DAP; in contrast sites, labs or companies that want to perform POCT on asymptomatic individuals for COVID-19 screening purposes at no cost do not need DAP accreditation and instead will be supported by BCCDC [4]. Notably, all these methods of implementing POCT place emphasis on three key areas critical for well-managed and accurate POC test delivery: effective training for operators, adherence to defined quality processes and standards, and some form of quality control and/or proficiency testing requirement. As all models agree on these points and given that a 2017 CADTH Environmental Assessment identified that there is broad interest in Canada for standardization of POCT delivery models [3], I believe now is the time to move from our fragmented POCT programs and come together to generate a consistent set of least burdensome requirements for a pan-Canadian framework for POCT and program implementation.  

While the pandemic has dominated our thoughts for the last 18 months we need to look beyond COVID-19, and casting our gaze forward it is easy to envision a future that will include POCT for various novel biomarkers as innovations in personalized medicine continue to advance. COVID-19 has accelerated the design and implementation of many aspects of healthcare delivery; I believe it is now time to add a re-think of our POCT programs to the list of healthcare improvements to be addressed in the near term.  This pandemic has increased dialogue and promoted a spirit of innovation and collaboration between our scientific and healthcare communities; it would be a an inspiring step forward if we could harness this energy and determination to attain another significant achievement which has eluded the community for the last 20+ years – the development of a unified, streamlined, and effective POCT delivery model that will allow all Canadians to have equal access to state-of-the art and timely healthcare. Truly an opportunity not to be wasted.

[1]  “Medical Directives.” (accessed Sep. 19, 2021).

[2] “Diagnostic Accreditation Program.” (accessed Sep. 19, 2021).

[3]  T. Quay et al., “Point-of-Care Testing,” 2017.

[4] B. Henry, “covid-19-pho-letter-dap-poc-testing”, Accessed: Sep. 19, 2021. [Online]. Available:


Novateur Newsletter

Subscribe to our newsletter for access to latest updates.

Resource Databases

Access Novateur news as well as FDA and Expert Databases.

Relevant Events

Check out conferences and events we are attending!