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目的考察ACYW135群脑膜炎球菌多糖疫苗对人新鲜全血体外热原检测IL-1β法及IL-6法的适用性。方法选取不同厂家共14批供试品,使用人新鲜全血体外热原检测法,采用加样回收干扰实验考察供试品是否存在干扰。结果 14批供试品在最大有效稀释倍数内,IL-1β法及IL-6法干扰实验的回收率均在50%~200%,且热原物质含量均低于标准限值,均为合格样品。结论人新鲜全血体外热原检测IL-1β法及IL-6法可用于ACYW135群脑膜炎球菌多糖疫苗热原检测。
Objective To investigate the applicability of ACYW135 meningococcal polysaccharide vaccine to detection of IL-1β and IL-6 in human fresh whole blood by exogenous pyrogen. Methods A total of 14 batches of test products from different manufacturers were selected and the whole blood exogenous pyrogen test was used to detect the presence of interference in the test sample. Results The recoveries of IL-1β and IL-6 interference experiments were all within 50% ~ 200% of the 14 batches of samples at the maximum effective dilution, and the pyrogen content was below the standard limit sample. Conclusion The detection of IL-1β and IL-6 by human whole blood exogenous pyrogen can be used to detect the pyrogen of ACYW135 meningococcal polysaccharide vaccine.