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

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; 2Divis...

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Autores principales: Uchida T, Kaku Y, Hayasaka H, Kofuji M, Momose N, Miyazawa H, Ueda Y, Ito K, Ookawara S, Morishita Y
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Publicado: Dove Medical Press 2019
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spelling oai:doaj.org-article:b4d0fea4316740078975f9d4b3302dc52021-12-02T06:39:30ZUtility Of An Automatic Limulus Amebocyte Lysate Kinetic Turbidimetric Test For Endotoxin Screening Of Dialysate Samples1179-1470https://doaj.org/article/b4d0fea4316740078975f9d4b3302dc52019-10-01T00:00:00Zhttps://www.dovepress.com/utility-of-an-automatic-limulus-amebocyte-lysate-kinetic-turbidimetric-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Takayuki 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 workCorrespondence: Yoshiyuki MorishitaDivision of Nephrology, First Department of Integrated Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama-City, Saitama 330-8503, JapanTel +81-48-647-2111Fax +81-48-647-6831Email ymori@jichi.ac.jpBackground: 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  Uchida TKaku YHayasaka HKofuji MMomose NMiyazawa HUeda YIto KOokawara SMorishita YDove Medical PressarticleendotoxindialysatehemodialysisLimulus amebocyte lysatechromogenic substrateMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 12, Pp 429-433 (2019)
institution DOAJ
collection DOAJ
language EN
topic endotoxin
dialysate
hemodialysis
Limulus amebocyte lysate
chromogenic substrate
Medical technology
R855-855.5
spellingShingle endotoxin
dialysate
hemodialysis
Limulus amebocyte lysate
chromogenic substrate
Medical technology
R855-855.5
Uchida T
Kaku Y
Hayasaka H
Kofuji M
Momose N
Miyazawa H
Ueda Y
Ito K
Ookawara S
Morishita Y
Utility Of An Automatic Limulus Amebocyte Lysate Kinetic Turbidimetric Test For Endotoxin Screening Of Dialysate Samples
description 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 workCorrespondence: Yoshiyuki MorishitaDivision of Nephrology, First Department of Integrated Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama-City, Saitama 330-8503, JapanTel +81-48-647-2111Fax +81-48-647-6831Email ymori@jichi.ac.jpBackground: 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  
format article
author Uchida T
Kaku Y
Hayasaka H
Kofuji M
Momose N
Miyazawa H
Ueda Y
Ito K
Ookawara S
Morishita Y
author_facet Uchida T
Kaku Y
Hayasaka H
Kofuji M
Momose N
Miyazawa H
Ueda Y
Ito K
Ookawara S
Morishita Y
author_sort Uchida T
title Utility Of An Automatic Limulus Amebocyte Lysate Kinetic Turbidimetric Test For Endotoxin Screening Of Dialysate Samples
title_short Utility Of An Automatic Limulus Amebocyte Lysate Kinetic Turbidimetric Test For Endotoxin Screening Of Dialysate Samples
title_full Utility Of An Automatic Limulus Amebocyte Lysate Kinetic Turbidimetric Test For Endotoxin Screening Of Dialysate Samples
title_fullStr Utility Of An Automatic Limulus Amebocyte Lysate Kinetic Turbidimetric Test For Endotoxin Screening Of Dialysate Samples
title_full_unstemmed Utility Of An Automatic Limulus Amebocyte Lysate Kinetic Turbidimetric Test For Endotoxin Screening Of Dialysate Samples
title_sort utility of an automatic limulus amebocyte lysate kinetic turbidimetric test for endotoxin screening of dialysate samples
publisher Dove Medical Press
publishDate 2019
url https://doaj.org/article/b4d0fea4316740078975f9d4b3302dc5
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