Test results in minutes, not hours, improves diagnosis, helps save lives

Departments - Expert design

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.

April 15, 2010
Elizabeth Engler Modic

The QL Care analyzer is unique in that it has 300 parts, but no moving parts.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.

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.

 Utilizing single-use cartridges, the QL Care analyzer can deliver test results in the emergency room, doctor’s office, or an EMS vehicle.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.”

Quantum Leap
“Amazingly, today’s lab-based immuno-diagnostics require more than 2.8 hours to deliver testing results following the sample collection, so there is a definite need for faster, more efficient patient-side testing,” Gawad explains.

He feels that the QL Care analyzer provides that solution for several reasons. It is the first POC analyzer to employ chemiluminescence; the first to use a photon-multiplying device to measure light released, therefore maximizing the testing sensitivity; and the first to eliminate membrane-binding, which is a major cause of testing inaccuracy.

Weighing approximately 7 lb and measuring 8" x 9" x 5", the analyzer has the capacity to hold 5,000 patient records and to be operated by personnel who lack specific laboratory training, as well as by testing specialists. User interaction with the QL Care analyzer is further simplified through the step-by-step instructions on the LCD touch screen.

In merely six steps the QL Care analyzer can deliver test results in the emergency room, doctor’s office, or an EMS vehicle. In addition to providing printed medical lab-quality results, the data can easily be transferred to any network via RS323 and USB ports, with Bluetooth functionality on the horizon.

First, the user initiates operation of the machine by flipping the screen up and tapping the intuitive user-interface touch-screen. When prompted, the operator opens the cartridge door and inserts the cartridge for the test to be performed. Once the cartridge has been loaded, the user adds the sample to the cartridge, closes the door, and the test begins. The intuitiveness of the machine’s operation is illustrated by its ability to automatically identify the type of test that needs to be run from a barcode located on the cartridge. Once this is determined, the machine loads the required software and runs the appropriate test. A lot-specific calibration curve is included in the barcode inserted on the cartridge. While the test is running, the operator is free to enter patient data.

Within 15 minutes, results are displayed on the LCD, electronically stored in the machine, and/or forwarded to the desired network. Additionally, results can be printed on the thermal label printer. To ensure an error-free testing environment, the barcode scanner can scan the primary sample tube on the test cartridge to verify the results. Finally, the single-use cartridge is removed and disposed of, leaving the QL Care analyzer ready for the next patient and the next test.

Future Steps
Currently, CGI is adapting several test products for the QL Care analyzer. Once test adaptation is achieved, CGI will initiate beta-site testing. Four hospitals in Canada and the United States are already lined up for this testing. Once CGI is satisfied with the beta-site testing results, FDA clinical testing and data collection will be initiated.

“I expect we will initiate FDA submission of the QL Care analyzer within the next 14 to 16 months,” Gawad states. “The average approval time for this class of device is 96 days.” In regard to mass rollout of the QL Care analyzer, “design and testing aspects have all been brought in-house, or at least the measured portion, but when looking at manufacturing for full-scale product roll-out, contract manufacturing is what we plan,” Gawad says. “In order to minimize capital costs and maintain a focus on core competencies, CGI plans to have the QL Care analyzer manufactured and assembled under agreements with OEM partners that possess the necessary expertise. Further OEM sources with relevant expertise will be contracted out of the production of commercial lots of test cartridges.”

So, as Gawad and CGI work toward commercial launch, they face a set of challenges: optimizing the cartridge design for handling non-metered samples; importing developed test products to the POC cartridge format; beta-site testing of the developed POC platform and test product; and obtaining FDA and other necessary regulatory approvals for full commercialization. Once all is addressed and FDA approval is achieved, many more lives may be saved with fast test results aiding in the correct diagnosis and treatment.

CardioGenics Inc.
Mississauga, Ontario, Canada