压力蒸汽灭菌监测快速生物指示剂生物培养效果一致性的鉴定方法研究  

Evaluation of rapid bio-indicator on monitoring the effectiveness of steam sterilization

作　　者：陈金龙[1] 帖金凤[1] 王长德[1] 张文福[1] 

机构地区：[1]军事医学科学院疾病预防控制所,北京100071

出　　处：《中国预防医学杂志》2013年第11期827-831,共5页Chinese Preventive Medicine

基　　金：北京市科技新星计划资助项目(Z131102000413069)

摘　　要：目的建立一种研究压力蒸汽灭菌监测快速生物指示剂快速培养3h和普通培养箱56℃培养48h与168h结果一致性的评价方法。方法用压力蒸汽灭菌生物指示剂检测器,对国产和进口的压力蒸汽灭菌监测快速生物指示剂进行121℃,3个作用时间点(5min、10min、15min)的灭菌,观察灭菌后用快速阅读培养器快速培养3h和移入普通培养箱56℃培养48h与168h的结果一致性。结果国产和进口压力蒸汽灭菌监测快速生物指示剂的D值分别为1.60min和1.56min;在121℃饱和蒸汽条件下测定,作用时间为5min时,进口和国产快速生物指示剂快速培养结果与普通培养48h与168h结果一致,均显阳性;作用时间为10min时,5次重复实验,国产快速生物指示剂快速培养3h出现假阳性率分别为:25%、45%、30%、0、5%,平均假阳性率为21%;进口快速生物指示剂快速培养3h出现假阳性率分别为:35%、35%、60%、10%,5%,平均假阳性率为29%;作用时间为15min时,国产和进口快速生物指示剂快速培养3h结果与普通培养48h与168h结果一致,均显阴性。结论快速生物指示剂显示的阴性结果准确度高,可判定灭菌合格,快速生物指示剂显示的阳性结果有较高的假阳性率,不能判断灭菌失败,需要将阳性指示剂管移入普通培养箱进行56℃培养48h,根据56℃培养48h的结果做最终的判定。Objective To evaluate the effectiveness of rapid biological indicators on monitoring the efficiency of steam sterilization by comparing the consistency of incubation results. Methods A bio-indicator detector was used in the study. Both domestic and imported rapid bio-indicators were steam sterilized at 121 ℃ for 5 min, 10 min and 15 min, respectively. Then they were removed into fast reading incubator for 3 h incubation or to the regular incubator at 56 ℃ for 48 h or 168 h incubation. The incubation results were compared and analyzed. Results The D values of domestic and imported steam sterilization monitoring rapid bio-indicator were 1.60 min and 1.56 min, respectively. After 5 min steam sterilization at 121 ℃, both imported and domestic rapid bio-indicators showed positive results under all three different incubations. Domestic rapid bio-indicator showed false positive under 3 h fast incubation when sterilized for 10 rain. This was repeated 5 times with the false positive rates of 25%, 45%, 30%, 0% and 5%. Imported bio-indicator also showed false positive with the rtes of 35%, 35%, 60%, 10% and 5%. When sterilized for 15 min, both domestic and imported bio indicators turned to be negative under all three incubations. Conclusions The negative result of rapid bio-indieator is accurate enough and reliable to determine the complete sterilization. However, when it is positive, that doesnr t necessarily mean the failed sterilization because it has relatively higher false positive rates. The positive indicator needs to be further removed into regular incubator for 48 h incubation at 56 ℃ in order to make final decision.

关 键 词：压力蒸汽灭菌监测 快速生物指示剂 生物培养 一致性 

分 类 号：R187.2[医药卫生—流行病学]