Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
J Microbiol Immunol Infect. 2019 Oct;52(5):760-768. doi: 10.1016/j.jmii.2019.04.005. Epub 2019 Apr 30.
BACKGROUND/PURPOSE: Early recognition of causative pathogens is critical for the appropriate management of central nervous system infection and improved outcomes. The BioFire FilmArray Meningitis/Encephalitis Panel (BioFire ME Panel, BioFire Diagnostics) is the first U.S. Food and Drug Administration (FDA)-approved multiplex PCR assay that allows the rapid detection of 14 pathogens, including bacteria (n = 6), viruses (n = 7), and fungi (n = 1), from cerebrospinal fluid (CSF). The performance of the panel is expected to be dependent on the epidemiology of M/E in different geographical regions.
In this preliminary study, we used the BioFire ME Panel in 42 subjects who presented to the emergency department with symptoms of M/E in our hospital. The results were compared to conventional culture, antigen detection, PCR, and various laboratory findings.
The panel detected six positive samples, of which five were viral and one bacterial. We observed an overall agreement rate of 88% between the BioFire ME Panel results and the conventional methods. There were no false-positive findings, but five discordant results were observed for enterovirus, herpes simplex virus type 1, Escherichia coli, and Cryptococcus species.
The BioFire ME Panel performed equivalently to the traditional PCR methods for virus detection, and better than bacterial cultures. This revolutionary system represents a paradigm shift in the diagnosis of M/E and may aid in the rapid identification of community-acquired M/E. However, the usefulness of this tool is limited in regions with a high prevalence of infectious M/E caused by microorganisms not included in the panel.
背景/目的:早期识别病原体对于中枢神经系统感染的适当治疗和改善预后至关重要。BioFire FilmArray 脑膜炎/脑炎检测试剂盒(BioFire ME 检测试剂盒,BioFire Diagnostics)是美国食品和药物管理局(FDA)批准的首个可快速检测包括细菌(n=6)、病毒(n=7)和真菌(n=1)在内的 14 种病原体的多重 PCR 检测试剂盒,其检测样本来自脑脊液(CSF)。该检测试剂盒的性能预计将取决于不同地理区域的 M/E 流行病学情况。
在本初步研究中,我们使用 BioFire ME 检测试剂盒对我院急诊就诊并出现 M/E 症状的 42 例患者进行了检测。将检测结果与传统培养、抗原检测、PCR 和各种实验室检查结果进行了比较。
该检测试剂盒共检测出 6 个阳性样本,其中 5 个为病毒,1 个为细菌。我们观察到,BioFire ME 检测试剂盒与传统方法的总符合率为 88%。未出现假阳性结果,但在检测肠道病毒、单纯疱疹病毒 1 型、大肠杆菌和隐球菌时出现了 5 个不一致的结果。
BioFire ME 检测试剂盒在病毒检测方面与传统 PCR 方法的性能相当,优于细菌培养。这一革命性系统代表了 M/E 诊断方法的范式转变,可能有助于快速识别社区获得性 M/E。然而,在由未包含在检测试剂盒中的微生物引起的感染性 M/E 流行率较高的地区,该工具的用途有限。