过氧化氢灭菌快速生物指示物荧光结果可靠性  

Reliability of fluorescence reaction results of rapid biological indicator for hydrogen peroxide sterilization

作　　者：吴志萍[1] 周倩 黄蓉 白天宇 刘蓬 WU Zhi-ping;ZHOU Qian;HUANG Rong;BAI Tian-yu;LIU Peng(The First Affiliated Hospital of Nanchang University,Nanchang,Jiangri 330006,China;不详)

机构地区：[1]南昌大学第一附属医院消毒供应中心,江西南昌330006 [2]3M中国有限公司,上海200336 [3]南昌大学第一附属医院检验科,江西南昌330006

出　　处：《中华医院感染学杂志》2024年第6期946-949,共4页Chinese Journal of Nosocomiology

基　　金：江西省卫生健康委科技计划基金资助项目(202130308)。

摘　　要：目的 通过验证快速生物指示物荧光反应结果的可靠性,指导消毒供应中心正确进行生物监测,以实现精准质量管理。方法 将36支三个批次的快速自含式生物指示物分为空白对照组、阳性对照组、不同装载方式灭菌的试验组,通过培养仪荧光判读、温箱培养观察、pH值检测、分光光度法、芽孢恢复培养、显微镜观察等方法,从多个角度研究分析和判断快速生物指示物荧光结果和残留菌量的关系。结果 试验组荧光阴性结果的生物指示物颜色变化均为阴性,其温箱培养观察、pH值检测、分光光度结果与空白对照组数据接近,芽孢恢复培养无菌生长,为真阴性;试验组荧光阳性、颜色变化阳性结果的生物指示物pH值结果及分光光度结果与阳性对照组数据接近,芽孢恢复培养有菌生长,为真阳性;试验组荧光阳性、颜色变化阴性结果的生物指示物分光光度结果与阳性对照组数据接近,pH值检测结果与空白对照组接近,芽孢恢复培养无菌生长,为处于临界状态的假阳性。结论 快速自含式生物指示物灭菌后荧光阴性结果可靠,可作为灭菌物品放行依据。荧光阳性结果需进一步验证其是真阳性还是假阳性,重新灭菌荧光结果阴性后放行为符合安全及实际需求的选择。OBJECTIVE To verify the reliability of the fluorescence reaction results of rapid biological indicator for hydrogen peroxide sterilization and provide guidance for biological monitoring in central sterilization supply depart-ment so as to achieve precise quality management.METHODS Three batches of rapid self-contained biological indi-cators were divided into the blank group,the positive control group and the experimental group with different loading methods for sterilization.The relationship between the fluorescence reaction results of rapid biological indi-cators and the colony counts of residual bacteria was analyzed and judged from multiple angles by means of incuba-tor fluorescence interpretation,incubator culture observation,pH detection,spectrophotometry,spore recovery culture and microscopic observation.RESULTS The color changes of biological indicators were all negative for the fluorescence reaction result in the experimental group,the results of incubator culture,pH detection and spectro-photometry of the experimental group were similar to the data of the control group,there was no bacterial growth for spore recovery culture,and it was true negative.The results of pH value and spectrophotometry of biological indicator of positive fluorescence and positive color change results were similar in the experimental group and the positive control group,there was bacterial growth for the spore recovery culture,and it was true positive.The spectrophotometry result of biological indicators of the positive fluorescence and negative color change results of the experimental group were similar to the data of the positive control group,the pH value of the experimental group was similar to that of the blank control group,there was no bacterial growth for the spore recovery culture,and it was false positive at the critical state.CONCLUSION The rapid self-contained biological indicator has a relia-ble negative result for fluorescent reaction after sterilization,which can serve as an basis for sterilization of arti-cles.The

关 键 词：过氧化氢灭菌 快速自含式 生物指示物 恢复培养 荧光反应 

分 类 号：R187[医药卫生—流行病学]