上海地区血液成分无菌试验检测结果评估

doi:10.3969/j.issn.1671-2587.2025.03.012

临床输血与检验 ›› 2025, Vol. 27 ›› Issue (3): 354-359.DOI: 10.3969/j.issn.1671-2587.2025.03.012

上海地区血液成分无菌试验检测结果评估

杨剑豪, 章怿, 章舜玮, 陆贇, 邱颖婕

上海市血液中心, 上海 200051

收稿日期:2024-12-06 发布日期:2025-06-23
通讯作者: 邱颖婕,主要从事血站质量控制和质量体系审核工作,（E-mail）qiuyingjie@sbc.org.cn。
作者简介:杨剑豪,主要从事采供血机构质量控制工作,（E-mail）yangjianhao@sbc.org.cn。并列第一作者：章怿,主要从事输血相关研究和质量管理工作,（E-mail）zhangyi@sbc.org.cn。

Evaluation of Blood Component Sterility Test Results in the Shanghai Area

YANG Jianhao, ZHANG Yi, ZHANG Shunwei, LU Yun, QIU Yingjie

Shanghai Blood Center, Shanghai 200051

Received:2024-12-06 Published:2025-06-23

摘要/Abstract

摘要： 目的对上海市血液中心检测的410 599袋血液成分无菌试验结果进行回顾性分析,评估上海地区血液细菌污染发生及控制情况,为制定检测策略和预防措施提供依据。方法 2017年1月—2023年12月,上海市血液中心将血液成分取样至留样袋,保质期内进行细菌培养筛查,统计分析确认阳性细菌数据。结果 410 599袋3类血液成分的总体细菌检出率为0.22‰,经过基质辅助激光解吸飞行时间质谱仪（MALDI-TOF MS）鉴定,共检测出91例细菌样本,合计19种细菌,其中血小板类血液成分检出数量最高的细菌为表皮葡萄球菌（21例）,最低的分别为克劳氏芽孢杆菌、停乳链球菌、土味类芽孢杆菌及痤疮丙酸杆菌,各检出1例;在红细胞类血液成分中检出8例痤疮丙酸杆菌;在血浆类血液成分中检出1例痤疮丙酸杆菌和1例蜡样芽孢杆菌;确认阳性结果中报阳时间最长的是痤疮丙酸杆菌（87.50 h）,最短的是蜡样芽孢杆菌（2.03 h）;在12 h内被检出的细菌依次是蜡样芽孢杆菌、加氏乳球菌、地衣芽孢杆菌、无乳链球菌、金黄色葡萄球菌、大肠埃希菌;报阳时间在12 h~24 h内被检出的细菌依次是表皮葡萄球菌、泛血败菌属、停乳链球菌、土味类芽孢杆菌、奇异变形杆菌。结论采用自动化血培养系统对上海地区血液成分进行细菌检测,得到了较为完整可靠的大样本细菌筛查数据,3类抽检的血液成分质控抽检模式中以厌氧菌检出为主;单采血小板100%无菌试验模式中检出的细菌以凝固酶阴性的葡萄球菌为主,本研究也可为相关标准或规程提供参考依据。

关键词: 全血及成分血, 无菌试验, 细菌污染, 自动化血培养系统, 质谱技术, 血液安全

Abstract: Objective To retrospectively analyze the sterility test results of 410 599 blood component bags tested by Shanghai Blood Center, evaluate the occurrence and control of bacterial contamination in blood products in Shanghai, and provide a basis for developing detection strategies and preventive measures. Methods From January, 2017 to December, 2023, Shanghai Blood Center sampled blood components into bags, inoculated them into culture bottles, and used an automatic blood culture system for bacterial screening. Positive bacterial data were statistically analyzed and confirmed. Results The overall bacterial detection rate of three blood components from January 2017 to December 2023 was 0.22‰. A total of 91 bacterial samples were identified by MALDI-TOF MS, with 19 different types of bacteria detected. The most common bacteria in platelet components was Staphylococcus epidermidis (21 cases), while the least common were Bacillus Claudius, Streptococcus lactis, Bacteroides terrestris and Propionibacterium acnes, each detected once. Eight cases of Propionibacterium acnes were found in red blood cell components. Plasma components showed one case of Propionibacterium acnes and one case of Bacillus cereus. The longest positive culture time was Propionibacterium acnes (87.5 hours), and the shortest was Bacillus cereus (2.03 hours). The bacteria detected within 12 hours included Bacillus cereus, Lactococcus gasseri, Bacillus licheniformis, Streptococcus agalactiae, Staphylococcus aureus and Escherichia coli. Within 12~24 hurs Staphylococcus epidermidis, Septicemia, Streptococcus lactis, Bacteroides terrestris and Proteus mirabilis were detected. Conclusion The use of an automated blood culture system for detecting bacterial contamination in blood components in Shanghai provided reliable data from large sample screenings. Anaerobic bacteria were primarily detected the blood components. Coagulase-negative staphylococci were the main bacteria identified in platelets, and this study provides valuable reference for developing relevant standards and procedures for blood product sterility testing.

Key words: Whole blood and blood components, Sterility test, Bacterial contamination, Automated microbial inoculation system, MALDI-TOF MS, Blood safety

中图分类号:

R372R466.5

杨剑豪, 章怿, 章舜玮, 陆贇, 邱颖婕. 上海地区血液成分无菌试验检测结果评估[J]. 临床输血与检验, 2025, 27(3): 354-359.

YANG Jianhao, ZHANG Yi, ZHANG Shunwei, LU Yun, QIU Yingjie. Evaluation of Blood Component Sterility Test Results in the Shanghai Area[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2025, 27(3): 354-359.

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上海地区血液成分无菌试验检测结果评估

Evaluation of Blood Component Sterility Test Results in the Shanghai Area

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