评估 FilmArray™ 脑膜炎/脑炎试剂盒，重点关注细菌和隐球菌属。

Evaluation of the FilmArray™ Meningitis/Encephalitis panel with focus on bacteria and Cryptococcus spp.

机构信息

Department of Laboratory Medicine, Clinical Microbiology, University Hospital, Örebro SE-701 85, Sweden.

Department of Laboratory Medicine, Clinical Microbiology, University Hospital, Örebro SE-701 85, Sweden; Department of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro SE-701 82, Sweden.

出版信息

J Microbiol Methods. 2019 Feb;157:113-116. doi: 10.1016/j.mimet.2019.01.003. Epub 2019 Jan 10.

DOI:10.1016/j.mimet.2019.01.003

PMID:30639516

Abstract

PURPOSE

Molecular methods provide fast and accurate detection of both bacteria and viruses in the cerebrospinal fluid (CSF) causing infection in the central nervous system (CNS). In the present study we evaluated the bacterial detection performance of the fully automated FilmArray™ Meningitis/Encephalitis (ME) panel (bioMérieux) by comparing it with culture and multiplexed in-house PCR.

METHODS

Three sample types were analysed; Contrived samples with known bacterial/fungal concentration (n = 29), clinical samples from patients with verified cause of CNS infection (n = 17) and external quality assessment (EQA) samples (n = 11). Another six samples were purposely prepared with multiple targets to evaluate multiplex capacity.

RESULTS

The FilmArray™ had a slightly higher limit of detection for Streptococcus pneumoniae, Neisseria meningitidis, Listeria monocytogenes and Streptococcus agalactiae compared to in-house PCR methods but performed equal or better when compared to culture. The FilmArray™ ME panel detected the expected pathogen in 17 of 17 clinical samples and yielded detection of three additional viruses of which one was confirmed with comparator techniques. All but one of the EQA samples were correctly detected.

CONCLUSIONS

The results of this study are promising and the FilmArray™ ME panel could add to the diagnostic algorithm in CNS-infections. However, the limit of detection for the important pathogens N. meningitidis and S. pneumoniae could be improved.

摘要

目的

分子方法可快速准确地检测引起中枢神经系统（CNS）感染的脑脊液（CSF）中的细菌和病毒。在本研究中，我们通过与培养和多重内部分子 PCR 比较，评估了全自动 FilmArray™脑膜炎/脑炎（ME）检测试剂盒（bioMérieux）的细菌检测性能。

方法

分析了三种样本类型；人工配制的已知细菌/真菌浓度样本（n=29）、经证实 CNS 感染病因的患者临床样本（n=17）和外部质量评估（EQA）样本（n=11）。另外六个样本故意制备了多个靶标，以评估多重检测能力。

结果

与内部分子 PCR 方法相比，FilmArray™ 对肺炎链球菌、脑膜炎奈瑟菌、李斯特菌和无乳链球菌的检测下限略高，但与培养相比，其性能相等或更好。FilmArray™ ME 检测试剂盒在 17 例临床样本中均检测到预期的病原体，并额外检测到三种病毒，其中一种通过比较方法得到确认。除了一个 EQA 样本外，其他所有样本均被正确检测到。