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Utility Of An Automatic Limulus Amebocyte Lysate Kinetic Turbidimetric Test For Endotoxin Screening Of Dialysate Samples

Authors Uchida T, Kaku Y, Hayasaka H, Kofuji M, Momose N, Miyazawa H, Ueda Y, Ito K, Ookawara S, Morishita Y

Received 29 July 2019

Accepted for publication 17 September 2019

Published 7 October 2019 Volume 2019:12 Pages 429—433

DOI https://doi.org/10.2147/MDER.S225246

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Melinda Thomas

Peer reviewer comments 2

Editor who approved publication: Dr Scott Fraser


Takayuki Uchida,1,* Yoshio Kaku,2,* Hideyuki Hayasaka,1 Masaya Kofuji,1 Naoki Momose,1 Haruhisa Miyazawa,2 Yuichiro Ueda,2 Kiyonori Ito,2 Susumu Ookawara,2 Yoshiyuki Morishita2

1Department of Clinical Engineering, Saitama Medical Center, Jichi Medical University, Saitama-City, Saitama, Japan; 2Division of Nephrology, First Department of Integrated Medicine, Saitama Medical Center, Jichi Medical University, Saitama-City, Saitama, Japan

*These authors contributed equally to this work

Correspondence: Yoshiyuki Morishita
Division of Nephrology, First Department of Integrated Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama-City, Saitama 330-8503, Japan
Tel +81-48-647-2111
Fax +81-48-647-6831
Email ymori@jichi.ac.jp

Background: Endotoxin contamination of dialysate has serious adverse effects on patients undergoing hemodialysis. Therefore, endotoxin activity in dialysate is closely monitored. Limulus amebocyte lysate (LAL) has been used as a reagent to measure endotoxin activity. Here, we investigated the efficacy of an automatic LAL kinetic turbidimetric test (Toxinometer ET-mini) for screening endotoxin activity in dialysate.
Methods: In total, endotoxin activity was measured in 110 dialysate samples obtained from several sites within hemodialysis circuits between June 2012 and March 2018. The results were compared with those from a conventional chromogenic substrate LAL test conducted by a clinical examination laboratory.
Results: Both the automatic LAL test and the chromogenic substrate LAL test had a minimum detection level of 0.001 endotoxin units (EU)/mL. Endotoxin activity levels measured via the automatic LAL test showed a strongly positive correlation (concordance correlation coefficient: 0.9933; 95% CI: 0.9902–0.9954) and good agreement (mean difference: 0.00±0.01 EU/mL) with those obtained using the chromogenic substrate LAL test.
Conclusion: The results suggest that the automatic LAL test may be useful for endotoxin activity screening in hemodialysis facilities.

Keywords: endotoxin, dialysate, hemodialysis, limulus amebocyte lysate, chromogenic substrate
 

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