Send to

Choose Destination
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

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



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.


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.

Supplemental Content

Full text links

Icon for Dove Medical Press Icon for PubMed Central
Loading ...
Support Center