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Med Devices (Auckl). 2019 Oct 7;12:429-433. doi: 10.2147/MDER.S225246. eCollection 2019.

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

Author information

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

Abstract

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:

chromogenic substrate; dialysate; endotoxin; hemodialysis; limulus amebocyte lysate

Conflict of interest statement

The authors declare that they have no conflicts of interest in this work.

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