Laboratory Medicine, Medical Microbiology, AZ Sint Lucas, Sint Lucaslaan 29, B-8310 Brugge, Belgium.
Laboratory Medicine, Medical Microbiology, AZ Sint-Jan, Ruddershove 10, B-8000 Brugge, Belgium.
J Med Microbiol. 2021 Oct;70(10). doi: 10.1099/jmm.0.001438.
The FilmArray Meningitis/Encephalitis (FA-ME) Panel (Biofire, Salt Lake City, Utah, US) enables fast and automated detection of 14 pathogens in cerebrospinal fluid (CSF). The performance of the FA-ME panel in a real routine setting has not yet been described and could lead to better patient management in cases of good performance. This multicenter study verified the FA-ME panel analytical performance in a routine hospital setting. Between April 2016 and April 2018, 454 CSF samples were analysed with the FA-ME panel and compared with routine diagnostics. In cases of discrepancy or lack of a comparator result, a profound analysis based on patient records and other laboratory results was performed. A first analysis of 65 frozen samples, suspicious for meningitis had a 89 % concordance with routine diagnostics. The limit of detection (LOD) was confirmed for all pathogens except for and a strain of and LOD experiments were not performed). The routine evaluation showed a positive result in 114 (25 %) clinical samples for at least one target. In three samples co-infections were found. After discrepancy analysis, overall sensitivity was 98 % (false negative FA-ME results for one HSV2, two HSV1 and two parechovirus). Four FA-ME results were considered false positive (two HHV6, one VZV and one ), resulting in an overall specificity of >99 %. A clinical added value of the assay was seen in the diagnosis of eight cases of bacterial meningitis. Because of its rapidity and ease of use, the FA-ME panel has great potential in the diagnosis of central nervous infections. Implementation can improve clinical management, but costs and analytical limitations need to be addressed to convince clinicians and laboratories of its value.
FilmArray 脑膜炎/脑炎（FA-ME）检测试剂盒（美国犹他州盐湖城的 Biofire）可快速自动检测脑脊液（CSF）中的 14 种病原体。FA-ME 检测试剂盒在实际常规环境中的性能尚未得到描述，而如果性能良好，则可能有助于改善患者的管理。这项多中心研究在常规医院环境中验证了 FA-ME 检测试剂盒的分析性能。2016 年 4 月至 2018 年 4 月期间，共对 454 份 CSF 样本进行了 FA-ME 检测试剂盒分析，并与常规诊断方法进行了比较。在出现差异或缺乏对照结果的情况下，根据患者的记录和其他实验室结果进行了深入分析。对 65 份疑似脑膜炎的冷冻样本进行了首次分析，与常规诊断方法的符合率为 89%。除 、 和 （未进行 检测试剂盒的 LOD 实验）外，所有病原体的检测限（LOD）均得到确认。常规评估显示，114 份（25%）临床样本中至少有一种靶标呈阳性结果。在三个样本中发现了混合感染。经过差异分析，总体敏感性为 98%（1 例单纯疱疹病毒 2 型、2 例单纯疱疹病毒 1 型和 2 例肠道病毒检测试剂盒结果为假阴性）。有 4 个 FA-ME 结果被认为是假阳性（2 例人类疱疹病毒 6 型、1 例水痘带状疱疹病毒和 1 例肠道病毒），总体特异性>99%。该检测试剂盒在诊断 8 例细菌性脑膜炎方面具有临床附加价值。由于其快速简便的特点，FA-ME 检测试剂盒在中枢神经系统感染的诊断中具有巨大的潜力。该方法的实施可以改善临床管理，但需要解决成本和分析局限性，以说服临床医生和实验室认可其价值。
