Device enables early, ‘real-time’ infection screening in peritoneal dialysis
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A screening device that attaches “in-line” to analyze white blood cell concentration in peritoneal effluent fluid — providing a “healthy,” “caution” or “risk” result at each treatment’s end — had 94% accuracy for infection-caution screening.
Janelle Kaneda, BSH, of the department of bioengineering at Stanford University, developed the device as a part of a capstone course; she told Healio Nephrology that her team sought to find a solution that might help improve management and outcomes for patients who require kidney replacement therapy.
“Current practices for peritonitis prevention are limited to standard sanitary measures and by the time that patients and caretakers notice symptoms, the infection has often progressed significantly,” Kaneda said. “Thus, we aimed to design an easy-to-use way to screen for infection as early as possible so that follow-up diagnostic testing and treatment can occur earlier to prevent peritoneal scarring and other complications that lead to high costs and premature transition to hemodialysis, the latter which is not always an optimal renal replacement therapy for people with end-stage renal disease.”
To determine if the device could distinguish between normal (0-10 white blood cells [WBCs]/mm3) and infection-indicating (100 WBCs/mm3) WBC levels, the researchers added WBCs to effluent fluid samples.
Results showed the device generated accurate predictions, while demonstrating the ability to distinguish between WBC levels. The model predicted 10 WBCs/mm3 to be 16.4 WBCs/mm3 and 100 WBCs/mm3 to be 110.9 WBCs/mm3; algorithm outputs for each concentration (0, 50 and 100 WBCs/mm3) were found to be statistically significantly different.
“Our team believes OpticLine can improve patient outcomes [and provides] peace of mind for both patients and caretakers by implementing an easy-to-use, automatic ‘check’ for infection in their peritoneal dialysis setup methods,” Kaneda said. “Patients and caretakers can depend on OpticLine to let them know as soon as possible when they should contact their care team, and thus receive earlier peritonitis treatment which will help mitigate infection progression and improve their peritoneal dialysis longevity.”
As for next steps, Kaneda told Healio Nephrology the team is concluding internal research and development (they are conducting human factors and market research studies) and will soon be seeking licensing agreements so that OpticLine can be commercialized and, subsequently, adopted into routine practice. Kaneda highlighted that the team is laying the groundwork for trials that test the safety and efficacy of the device during full peritoneal dialysis sessions.
“OpticLine provides the key first step in a chain of events that will improve patient outcomes that result from better management of peritonitis and preventing its severe progression,” Kaneda said. “With our support and mentorship from Stanford Engineering, Biodesign and Children’s Health, as well as from KidneyX and Mount Sinai Hospital, New York, we have been inspired to continue putting our best efforts toward developing this technology that can truly help peritoneal dialysis patients and their families.”
For more information, please contact Janelle Kaneda, BSH, at jkaneda@stanford.edu.
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Kaneda J, et al. Abstract #317. Presented at: National Kidney Foundation Spring Clinical Meetings (virtual meeting); April 6-10, 2021.
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