Primary Study on Pyrogen Test in Vitro for Medical Devices Using IL -1βELISA Method with Human Whole Blood
FAN Chunguang
SUN Likui
LIU Zengxiang
LIU Chenghu
LI Chunling
HOU Li
Abstract：The feasibility of applying IL -1βELISA method with human whole blood into pyrogen test in vitro for medical devices was validated.Comparison and analysis of the results between the two contact methods with test articles,direct contact method and ex-tract method,was conducted.For LPS O113,the LPS equivalent of direct contact method was higher than that of extract method;as for non -endotoxin pyrogen LTA,the LPS equivalent of direct contact method was approximately equal with that of extract method.Ac-cording to the results,it can be concluded that IL -1βELISA method with human whole blood can be applied into pyrogen test in vitro for endotoxin pyrogen and non -endotoxin pyrogen of medical devices,the incubation method is more efficient than the extract method.
Keywords：Pyrogen testIL -1βin vitroMedical devicesDirect contact method
Publication Date：2015-01-01
Online Publishing Date：2026-09-11(First online date of this platform, not the publication date of the document)
Pages：4( 192-195 )