The Japanese Journal of Clinical Dialysis Vol.35 No.5(2-8)

Theme Current topics in medical engineering technologies for dialysis therapy
Title Certification system for electrolyte analyzers used to measure dialysate concentration
Publish Date 2019/05
Author Kenichi Kokubo Kitasato University School of Allied Health Sciences / Japanese Society for Technology of Blood Purification
Author Yasushi Shimizu Department of Clinical Laboratory, Motomachi HD Clinic / Japanese Society for Technology of Blood Purification
Author Jun Murakami Department of Clinical Engineering, Tokyo Women's Medical University / Japanese Society for Technology of Blood Purification
Author Toshihiko Yamaka Department of Clinical Engineering, Faculty of Engineering, Kanagawa Institute of Technology / Japanese Society for Technology of Blood Purification
[ Summary ] Dialysate concentration is measured using an electrolyte analyzer with ion selective electrode (ISE) or an ISE-equipped blood gas analyzer; however, the measured values were different depending on the analyzer. In order to resolve this problem, we started a project with the cooperation of the Japan Society of Clinical Chemistry and Reference Material Institute for Clinical Chemistry Standards (ReCCS) to standardize the measurement of the concentration of the electrolyte contained in a dialysate. Through this project, the calibration standard solution for dialysate was made by ReCCS, the accuracy of the measurement value after calibration using the calibration standard solution was evaluated in each analyzer, the compatibility between the measured values of the analyzers was confirmed, and a certification system was established for measuring the concentrations of Na+, K+, Cl-, pH, and HCO3-.
Certification tests were conducted 2 times since then, and 19 commercially available models (7 as electrolyte analyzers and 12 as ISE-equipped blood gas analyzers) have been certified as analyzers meeting the criteria.
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