Abstract
Dialysis fluid purification is one way to ensure the safety of dialysis therapy. The level of endotoxins (ET) is an important index for safety management during dialysis because ET exhibit strong and extensive physiological activity. We evaluated the accuracy of a newly developed ET measurement method based on bioluminescence technology, using a common protocol at multiple facilities. In accordance with the validation guidelines prepared by the Japanese Society for Hemodiafiltration, we prepared a common protocol and performed the following evaluations at 6 facilities: the validity of the calibration curve, a blank test, a reaction interfering factor test, and assessments of the assay’s detection limit and the quantitation limit for dialysate measurement. These evaluations indicated that the bioluminescence-based method fulfilled the validation requirements of the HDF Research Group. In conclusion, since it exhibits high sensitivity and allows quick measurements, the new method was confirmed to be useful for biological contamination control of dialysis fluid.
