Multi-institutional study of a newly developed bioluminescent endotoxin measurement method based on the limulus amebocyte lysate reaction

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  • Kondo Mayumi
    Department of Clinical Engineering, Faculty of Health Sciences, Gunma PAZ University
  • Uchino Junji
    Mihama Hospital
  • Murakami Jun
    Department of Clinical Engineering, Tokyo Women’s Medical University
  • Hoshino Taketoshi
    Department of Clinical Engineering, Meirikai Central General Hospital
  • Yamashita Yoshihisa
    School of Clinical Engineering, Faculty of Health and Medical Care, Saitama Medical University
  • Naramura Tomotaka
    Department of Medical Technology, Faculty of Medical Science, University of East Asia
  • Shibamoto Takashi
    Department of Clinical Engineering, Faculty of Health Sciences, Gunma PAZ University

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Other Title
  • 新たに開発されたlimulus amebocyte lysate (LAL) 反応を用いた生物発光式エンドトキシン活性値測定装置 (ルミニッツ<sup>®</sup>-ET) の多施設評価
  • 新たに開発されたlimulus amebocyte lysate (LAL)反応を用いた生物発光式エンドトキシン活性値測定装置(ルミニッツ-ET)の多施設評価
  • アラタ ニ カイハツ サレタ limulus amebocyte lysate (LAL)ハンノウ オ モチイタ セイブツ ハッコウシキ エンドトキシン カッセイチ ソクテイ ソウチ(ルミニッツ-ET)ノ タシセツ ヒョウカ

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Abstract

<p>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.</p>

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