摘要
目的通过收集生物制剂生产中洁净间环境微生物、微生物限度检测样品,应用全自动微生物检测系统(VITEK 2 Compact)进行监测分析,评价其适用性。方法利用革兰染色法和VITEK 2 Compact系统对4种标准菌株和291个纯菌鉴定样本进行方法学验证;对人员及设备表面微生物、沉降菌及微生物限度样本共313个进行菌型鉴定,确认此系统在生物制剂生产中的应用价值。结果共在收集的313个样本中,共检出微生物268株,其中人员及设备表面微生物18株、沉降菌188株、微生物限度62株。可信度均在93%以上。其中革兰阳性菌:藤黄/里拉微球菌46次,库克菌属35次,葡萄球菌属70次;阴性菌:少动鞘氨醇单胞菌38次,鲁氏不动杆菌7次。结论 VITEK 2 Compact微生物检测系统具有高度特异性、敏感性和重复性,并具有操作简便、检测速度快等优点,可广泛应用于医院及疾控中心,尤其对无菌生产环境中微生物的质控和微生物数据库的建立具有重要意义。
Objective To collect microorganisms/bacteria in environment of clean site, samples for microbial limit, and VITEK 2 compact microbial detection system was carried to testing and analysis, then evaluating suitability for the system. Methods Gram staining and VITEK 2 compact microbial detection system were used in characterization of four kinds of standard strains and 291 pure bacteria for methodology validation; and bacterial type of 313 samples was detected, which included environmental monitoring bacteria, microbial limitation, in order to confirm the value of this system in biological production. Results In a total of 313 samples, 268 microbial strains were checked out including 18 strains of surface set- tied bacteria/microorganisms on personnel and equipment, 188 strains of settled bacteria, 62 strains of microbial limit, the credibility for these all are 〉93%. The Gram-positive bacteria are 46 times for micrococcus luteus/lylae, 35 times for kocu- ria, 80 times for staphylococcus. The Gram-negative bacteria are 38 times for sphingomonas paucimobilis, 7 times for acinetobacter lwoffii. Conclusion VITEK 2 compact microbial detection system has high specificity, sensitivity and repeatability, with advantages, such as easy operation, fast detection , and widely used in hospital and CDC, especially applied to the quality control of environmental microbiology in production of sterile biological products, it has an important significance in establishment of the environmental microbial database.
出处
《微生物学免疫学进展》
2015年第3期9-14,共6页
Progress In Microbiology and Immunology
