人全血IL-1β试验在医疗器械体外热原检测中的应用前景探讨

The Investigation of the Prospect of Applying Human Whole Blood Test for IL-1β into in Vitro Pyrogen Test for Medical Devices

目的:探讨人全血IL-1β试验在医疗器械热原体外检测中应用的可行性。方法:该研究采用梯度稀释的内毒素O113与人新鲜全血孵育,检测上清所含IL-1β的量并建立标准曲线;采用脂磷壁酸(LTA)溶液与新鲜人全血孵育,检测上清所含IL-1β的量并根据回归方程计算出LTA溶液的内毒素当量。结果:成功建立标准曲线,并计算出LTA溶液的内毒素当量。结论:经分析比较,该研究认为人全血IL-1β试验可用于医疗器械热原检测并能弥补传统方法的诸多不足。

Purpose： To investigate the feasibility of applying human whole blood test for IL-1β into in vitro pyrogen test for medical devices. Methods： Gradient diluted endotoxin O113 was incubated in human fresh blood and the content of IL-1β in supernatant was assayed to found standard curve. Lipoteichoicacid（LTA） solution was incubated in human fresh blood and the content of IL-1β in supernatant was also assayed to calculate its endotoxin equivalent weight according to regression equation. Results： standard curve was founded successfully and endotoxin equivalent weight of LTA solution was gained. Conclusions： According to the analysis and comparison, human whole blood test for IL-1β could be applied into in vitro pyrogen test for medical devices, which could make up the shortages of traditional methods.