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Title:: Primary Study on Pyrogen Test in Vitro for Medical Devices Using IL-1β ELISA Method with Human Whole Blood

作者:: 范春光; 孙立魁; 刘增祥; 刘成虎; 李春令; 侯丽△; 山东省医疗器械产品质量检验中心; 山东省医疗器械生物学评价重点实验室，山东济南 250101

Author(s):: FAN Chunguang; SUN Likui; LIU Zengxiang; LIU Chenghu; LI Chunling; HOU Li; Shandong Quality Inspection Center for Medical Devices; Shandong Provincial Key Lab of Biological Evaluation of Medical Devices of Shandong Province, Jinan 250101，China

Keywords:: Pyrogen test; IL-1β; in vitro; Medical devices; Direct contact method

摘要:: 对人全血IL-1βELISA法在医疗器械热原体外检测中应用的可行性进行了验证，并用该法对样品直接接触法和浸提液法这两种不同接触方法的检测结果进行了分析和比较。对于内毒素O113，直接接触法测得的内毒素当量高于样品浸提液中的测得量；对于非内毒素热原脂磷壁酸（LTA），直接接触法测得值与浸提液测得值量相当。结果表明，人全血IL-1βELISA试验可用于体外检测医疗器械中的内毒素和非内毒素热原，且直接接触法优于浸提液法。

Abstract:: The feasibility of applying IL-1β ELISA 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 extract 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. 〖JP2〗According to the results, it can be concluded that IL-1β ELISA 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.