2016—2018年上海地区单采血小板制品细菌污染检测结果分析与展望  

Analysis and prospect based on the detection of bacterial contamination in apheresis platelet products in Shanghai region,2016 to 2018

作　　者：徐蓓[1] 杨剑豪[1] 邱颖婕[1] 章舜玮[1] 傅剑敏 邹峥嵘[1] XU Bei;YANG Jianhao;QIU Yingjie;ZHANG Shunwei;FU Jianmin;ZOU Zhengrong(Shanghai Blood Center,Shanghai 200051,China.)

机构地区：[1]上海市血液中心

出　　处：《中国输血杂志》2018年第9期989-993,共5页Chinese Journal of Blood Transfusion

摘　　要：目的对2016—2018年上海市血液中心检测的88 066袋单采血小板制品细菌结果进行回顾性分析,评估上海地区单采血小板制品细菌污染发生及控制情况,为制定细菌污染检测策略和预防措施提供依据。方法将2016年7月至2018年6月上海市血液中心采集的单采血小板共88 066袋（2种单采设备分别为Amicus和MCS＋）,接种于BPA（需氧瓶）使用Bact/Alert 3D 240自动化微生物培养系统进行细菌检测,并将数据按时间顺序等分为2个阶段统计分析。结果单采血小板细菌检测结果显示：1） 2个阶段初始阳性率OR值为0. 73,确认阳性率OR值为15. 45,仪器误报引起的假阳性率OR值为0. 44,不确定阳性率OR值6. 76,P均〈0. 05。2）确认阳性在2种单采设备出现比例,P〉0. 05。3）所有细菌的平均检出时间最短的依次是大肠埃希菌、败血泛菌、头状葡萄球菌、短小芽孢杆菌、类芽孢杆菌属、人型葡萄球菌。结论通过对2016—2018年上海地区单采血小板制品进行细菌检测项目,能有效的控制细菌污染发生,减少因细菌感染引起的输血不良反应,保障单采血小板制品输注安全。为提高细菌检测捕获率,以及更好的保障献血者和受血者安全,提出以下改进方向：优化检测方法,提升细菌检测效率。建立血液安全监测体系,完善评估与回告机制。Objective This research retrospectively analyzed bacteria detection results of 88 066 bags of apheresis platelet（ PLT） products in shanghai blood center from 2016 to 2018 to evaluate the occurrence of bacterial contamination in apheresis Plt products in Shanghai region,providing basis for reducing bacterial contamination in apheresis Plt products and developing potential preventive measures. Methods A total of 88 066 bags of apheresis Plt components collected from the Shanghai Center from July 2016 to June 2018（ Plateletpheresis was performed using Amicus or MCS＋） were inoculated in BPA（ aerobic bottles）. Bacterial testing of apheresis Plt components was performed using the Bact/Alert 3 D 240 automated microbial culturing system. Data collection was conducted based on the test duration period which was divided in two periods equally. Results The results of apheresis Plt products bacterial test showed： 1. The odds ratio of initial-positive rates between the two periods were 0. 73; The odds ratio of the confirmed-positive rate was 15. 45; The odds ratio of false-positive rates were 0. 44; The indeterminate-positive rate were 6. 76. All results were statistically significant. 2. There was no statistically significant difference in the confirmed-positive rates of the two Plateletpheresis devices. 3. The bacteria that detected orderly in the detection time point order were Escherichia coli,Pantoea septicum,Staphylococcus aureus,Bacillus pumilus,Paenibacillus,Staphylococcus aureus. Conclusion According to the bacterial detecting results of apheresis platelet in the Shanghai region from 2016 to 2018,taking preventive measures by our center can effectively control the occurrence of bacterial contamination,reducing the adverse reactions of transfusion caused by bacterial contamination. To improve the detection rate of bacteria detection and better protect the safety of blood donors and recipients,the following improvement criteria are proposed： optimizing detection methods and improving the efficiency of

关 键 词：细菌污染 风险控制 单采血小板 持续改进 

分 类 号：R977.8[医药卫生—药品]