Application of Endotoxin Testing in Reducing the Risk of Hemodialysis Treatment

With the widespread development of hemodialysis technology, the quality and safety of dialysis water and dialysate have been paid more and more attention, and the heat source reaction caused by bacterial endotoxin is particularly important. Endotoxin is a complex of lipopolysaccharide and trace protein on the cell wall of Gram-negative bacteria. It is a kind of biologically active substance released after the death or disintegration of bacteria. It can enter the blood through the dialysis membrane, stimulate monocytes in the blood to produce cytokines, and cause patients to have a series of acute or chronic complications. Calculated based on 4 hours of each dialysis, the flow rate of dialysate is 500 ml/min. The blood of hemodialysis patients is about 120-150L of dialysate per dialysis. If the endotoxin content in the dialysate exceeds the standard, acute and chronic heat source reactions will occur during dialysis. This not only affects the dialysis effect, but also endangers the lives of patients. Therefore, it is particularly important to control the microbial contamination of the dialysate.

Endotoxin testing

Hemodialysis is widely used as an important treatment method for patients with chronic renal failure. However, dialysis treatment also has great risks. The heat source response caused by bacterial endotoxin is particularly important. American Association of the Advancement of Medical Instrumentation (AAMI) standards stipulate that the standard value of dialysis water bacteria should be <200CFU/ml, endotoxin <2EU/ml; when the bacterial measurement value exceeds 50 CFU/ml or the endotoxin measurement Interventions should be taken when the value exceeds 1 EU/ml. And the European Best Practice Guideline (EBPG) standards, that is, the standard value of bacteria for dialysis water should be less than 100 CFU/ml, and the standard value of endotoxin should be less than 0.25 EU/ml. We believe that the endotoxin limit of dialysis water should refer to the ISO endotoxin limit of 0.25 EU/ml, and the endotoxin limit of the dialysate should also be set to 0.5 EU/ml.

Dialysis treatment quality control

Strengthen the quality control of the dialysis process, establish a routine testing system, and take timely intervention measures when problems are found. Bacterial culture is performed once a month on dialysis water and dialysate, and bacterial endotoxin test is performed every 3 months. Bacterial and endotoxin tests on dialysate are tested at least once a year by each dialysis machine, and the monitoring results are done well. Record keeping. Endotoxin test is a method with mature technology and simple operation. However, during the dialysis process, the testing standard and frequency are low. It is recommended to implement ex-ante control as well as drug production. Ex-ante inspection should not be based on the test results or clinical response. Examination afterwards is not helpful. Once the biofilm is completely removed, it will be very difficult, and even equipment and pipelines need to be replaced.


In clinical work, a routine hemodialysis water and dialysate endotoxin testing system should be established, the reasonable limits of dialysis water and dialysate endotoxin should be standardized, and the reverse osmosis system and water pipelines, dialysis machines, and liquid distribution equipment (centralized Liquid system, liquid distribution tank and liquid storage tank), strictly aseptic operation, and orderly quality control management. If possible, use the original dialysate or centralized supply provided by the manufacturer. If you prepare it yourself, you should use it immediately. After the dialysis is completed, the remaining liquid is discarded and the container is cleaned, soaked in an appropriate amount of disinfectant and stored. This is bound to reduce the risk of dialysis and improve the quality of dialysis.

Creative BioMart offers a corresponding endotoxin testing service. You can purchase the corresponding endotoxin removal kit and related accessory products according to the needs of your own samples. We guarantee that all instruments, water, reagents, and consumables used in the experiment are free of endotoxins, and the experiment is conducted in a clean room to ensure that low levels of endotoxins are returned to the sample. In addition, we can also provide you with related services including:

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