对检测致病细菌的替代血液培养系统的评估:一个多地点的观察前性研究
Yanyan Hu1, Yinfei Fang2, Zelin Yan1
1Department of Clinical Laboratory, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.
这项研究发现,DL-Biotech和Meihua Medical的替代血液培养 (BC) 系统与毒症诊断的黄金标准系统相当. 这些具有成本效益的替代方案可以改善在低资源环境中获得关键诊断的机会.
科学领域:
- 临床微生物学 临床微生物学
- 传染性疾病 传染性疾病
- 医学诊断 医学诊断 医学诊断
背景情况:
- 败血症是一种危及生命的感染反应,发病率和死亡率不断增加.
- 血液培养 (BC) 系统对于败血症诊断至关重要,但高成本限制了低收入地区的可访问性.
- 本研究评估了与黄金标准系统相比的替代BC仪器和瓶子.
研究的目的:
- 与既有系统 (bioMérieux和Becton Dickinson) 相比,评估替代BC系统 (Meihua Medical和DL-Biotech) 的性能和可负担性.
- 确定这些替代BC系统是否适合临床使用,特别是在资源有限的环境中.
主要方法:
- 在五家三级医院对替代BC仪器和瓶子 (Meihua Medical [MH],DL-Biotech [DL]) 与bioMérieux和Becton Dickinson (BD) 进行了为期九个月的评估.
- 绩效指标包括时间到阳性 (TTP) 和敏感性后尖端与常见的病原体,如大肠杆菌和ESKAPE细菌.
- 在一项非劣势观察性研究中,共评估了37,480个BC瓶.
主要成果:
- DL和MH仪器显示了与BD和biomérieux系统相比较的时间到阳性 (TTP).
- 替代和黄金标准工具之间的一致率在96.5%至98.0%之间.
- 梅华医疗瓶的阳性生长数量高于biomérieux,但对无氧细菌的有效性较低;DL-Biotech的总体检测率低于biomérieux,但对大多数测试的病原体的TTP类似.
结论:
- 来自DL-Biotech和Meihua Medical的替代BC系统显示了与黄金标准系统 (BD,bioMérieux) 相比的性能.
- 这些替代性BC仪器和瓶子代表了改善低收入和中等收入国家的败血症诊断的可行选择.
- 采用这些具有成本效益的替代品可以支持抗微生物药物管理,并在全球范围内加强临床护理.
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