Methodological Study of Recombinant Factor C Method for Detection of Bacterial Endotoxins in Medical Devices
Objective To explore the applicability of recombinant factor C method in the detection of bacterial endotoxin in different medical devices,in order to provide basis for the use of recombinant factor C method in medical device testing.Methods Based on 9251 Application Guidelines of Bacterial Endotoxin Detection listed in the Fourth Part of Chinese Pharmacopoeia(2020 Edition),the accuracy of the recombinant factor C detection method was verified.And according to the classification of medical devices in GB/T 16886.1-2011,different medical device samples were selected.The recombinant factor C kit was used for detection,compared with the gel colt method and dynamic turbidity method.Results The measured values of the high,medium and low concentrations of endotoxin standards by recombinant factor C method were well correlated with the theoretical values,indicating that the method had good accuracy.The ratios of the detection values of different medical device products using recombinant factor C method and dynamic turbidity method were in the range of 50%-200%,and the recoveries were in the range of 50%-200%,which were also consistent with the test results of the gel colt method.Conclusion The recombinant factor C method has good applicability for the detection of bacterial endotoxin in medical devices.
bacterial endotoxinrecombinant factor C methodlimulus amebocyte lysatemedical device
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