Utility of An Automatic Limulus Amebocyte Lysate Kinetic Turbidimetric Test for Endotoxin Screening of Dialysate Samples

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

Medical Devices 12: 429-433


ISSN/ISBN: 1179-1470
PMID: 31632161
DOI: 10.2147/mder.s225246
Accession: 069435986

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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. 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. 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. The results suggest that the automatic LAL test may be useful for endotoxin activity screening in hemodialysis facilities.