Test Results In Minutes, Not Hours, Improves Diagnosis, Helps Save Lives

A sensitive and accurate point-of-care (POC) analyzer has been designed to improve medical care through more timely and accurate diagnosis for the patient and the medical practitioner, with results now capable of being delivered in minutes rather than hours. In addition to producing fast and accurate results, the analyzer offers a reduction in cost to the medical facility, which in turn means a reduction in cost to the patient.

Dr. Yahia Gawad, founder and CEO of CardioGenics Inc. (CGI), has played a significant role in the creation of the QL Care analyzer. “I initiated the process of developing this product back in 1998,” Gawad says.  “I looked into what was available in the market at that time, for a POC analyzer, and came to the conclusion that I needed to develop and build one from the bottom up. I ended up with the idea of developing a POC analyzer based on chemiluminescence, obtaining the necessary patents, and then – after conducting some initial experiments – I handed the process off to a third-party for validation before proceeding with the actual product.”

The third-party used for validation was Photonic Research Ontario, one of 11 centers of excellence in the Canadian University system with an expertise in light manipulation – the area of specialization that was sought by Gawad and CGI. Chemiluminescence – chemical light generation – refers to the extraction of light from a chemical reaction, meaning that when two chemicals are mixed together the result is light emission. The resulting technology that Gawad decided to pursue for the POC analyzer was a core patented technology that is referred to as electrical-stimulation chemiluminescence.

Prototype/Testing
Once it was determined how the POC analyzer would function, a range of contract manufacturing organizations were relied upon for help in the design of the machine and its components, as well as the overall production of the final prototypes that would be used for demonstrations.

Although comprised of roughly 300 components, the QL Care analyzer is unique in that it has no moving parts – a strict requirement Gawad insisted upon from the start.

“Not having moving parts put a tremendous amount of constraint on the design aspect of the machine, but this was part of my vision – since moving parts are where most of the failures of clinical analyzers occur,” Gawad explains. “In order to ensure this condition, we implemented either electrical or electronic and electromagnetic components.”

The components, housed within the portable QL Care analyzer, include everything that is needed to have it perform as designed – including monitoring the cartridge, controlling the photo-counting device, maintaining constant unit temperature, and ensuring accurate results from the various cartridges. Integrated within the device is a small, thermal label printer. Separate from the device are disposable cartridges used for the actual analysis.

With the prototypes built, the product testing began. “What actually resulted,once we had a machine to run tests on, is an immunoanalyzer rather than just a simple POC machine,” Gawad says. “The QL Care analyzer actually performs all the testing steps automatically; all the steps needed for immunoassay analysis are completed without operator interference. Since the analyzer has no moving parts and we had to determine how to trigger chemiluminescence, it was a major challenge that took at least two-and-a-half years longer than we anticipated.  Now, however, the product is ready for testing and submission to the FDA.”

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Source: Today's Medical Developments