一种生物指示物无菌快速检测系统的构建  

Construction of a rapid detection system for sterility test biological indicators

作　　者：栾同青 张萌萌 郝建新 刘兴翠 张小涵 郝树彬 LUAN Tong-qing;ZHANG Meng-meng;HAO Jian-xin;LIU Xing-cui;ZHANG Xiao-han;HAO Shu-bin(NMPA Key Laboratory for Quality Evaluation of Medical Materials and Biological Protective Devices,Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Ji’nan Shandong 250101,China)

机构地区：[1]国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室、山东省医疗器械和药品包装检验研究院,山东济南250101

出　　处：《中国消毒学杂志》2024年第6期410-412,共3页Chinese Journal of Disinfection

摘　　要：目的研究一种生物指示物无菌试验的快速检测系统及其适用性。方法通过检测器和培养瓶快速检测系统,验证该生物指标快速检测系统的专属性和可行性。结果该快速检测系统的试验周期确定为45 h;经专属性验证表明培养瓶具有无菌性和促生长性。经检测限验证,快速检测系统的检测时间为18.8 h,检出率为75%;而常规方法的检测时间为27.4h,检出率为43%。结论本研究构建的生物指示物快速检测系统,相对于常规方法,提高了检验速度和检出率。Objective To study a rapid detection system for sterility test of biological indicators and its applicability.Methods The specificity and feasibility of the biological indicator rapid detection system were verified by the detector and the culture bottle rapid detection system.Results The test period of the system was determined to be 45 h.The specific verification proved that the culture bottle had sterility and growth promotion.The detection time of the rapid detection system was 18.8 h,and the detection rate was 75%.The detection time of the conventional method was 27.4 h,and the detection rate was 43%.Conclusion Compared with the conventional methods,the rapid detection system of biological indicators established in this study can improve the detection speed and detection rate.

关 键 词：生物指示物 快速检测系统 无菌检测 

分 类 号：R187[医药卫生—流行病学]