Institut für Medizinische Mikrobiologie, Virologie und Hygiene, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
BMC Infect Dis. 2020 Feb 22;20(1):170. doi: 10.1186/s12879-020-4904-4.
Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics. A syndromic panel testing approach like the FilmArray ME can accelerate diagnosis and therefore decrease the time to pathogen specific therapy. Yet, its clinical utility is controversial, mainly because of a remaining uncertainty in correct interpretation of results, limited data on its performance on clinical specimens and its relatively high costs. The aim of this study was to analyze clinical performance of the assay in a real life setting at a tertiary university hospital using a pragmatic and simple sample selection strategy to reduce the overall cost burden.
Over a period of 18 months we received 4623 CSF samples (2338 hospitalizations, 1601 individuals). FilmArray ME analysis was restricted to CSF-samples with a high pretest probability of infectious meningitis, e.g. positive Gram-stain, samples in which leukocytes and/or bacteria were evident or urgent suspicion of infection was communicated by clinicians. N = 171 samples matched to our risk criteria and were subjected to FilmArray ME analysis. Those samples were also analyzed by reference methods: culture only (n = 45), PCR only (n = 20) or both methods (n = 106).
56/171 (32.75%) were FilmArray ME positive. Bacterial pathogens were detected in 30/56 (53.57%), viral pathogens were detected in 27/56 (48.21%) and yeast DNA was detected in 1/56 (1.79%) of positive samples. Double detection occurred in 2/56 samples. In 52/56 (92.86%) FilmArray ME positive samples, results could be confirmed by the reference assays (sensitivity = 96.30%, specificity =96.58%).
The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis and can easily be implemented in routine diagnostic workflows. However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results. Moreover, considering the need for antimicrobial susceptibility testing, the use of molecular tests as a stand-alone diagnostic cannot be recommended.
感染性脑膜炎是一种严重的疾病，患者的预后取决于快速可靠的诊断。像 FilmArray ME 这样的综合征组检测方法可以加速诊断，从而缩短针对病原体的特定治疗时间。然而，其临床实用性存在争议，主要是因为对结果的正确解释仍然存在不确定性，关于其在临床标本上的性能的数据有限，以及相对较高的成本。本研究旨在通过一种实用且简单的样本选择策略来降低总体成本负担，在三级大学医院的实际环境中分析该检测方法的临床性能。
在 18 个月的时间里，我们共收到 4623 份 CSF 样本（2338 例住院患者，1601 人）。仅对具有感染性脑膜炎高度术前概率的 CSF 样本进行 FilmArray ME 分析，例如革兰氏染色阳性、白细胞和/或细菌明显或临床医生紧急怀疑感染。n=171 个符合我们风险标准的样本并进行 FilmArray ME 分析。这些样本还通过参考方法进行分析：仅培养（n=45）、仅 PCR（n=20）或两种方法（n=106）。
171 个样本中，有 56 个（32.75%）为 FilmArray ME 阳性。在 56 个阳性样本中，检测到细菌病原体 30 个（53.57%），病毒病原体 27 个（48.21%），酵母 DNA 1 个（1.79%）。2 个样本中出现双重检测。在 56 个 FilmArray ME 阳性样本中，52 个（92.86%）的结果可通过参考检测方法得到确认（敏感性=96.30%，特异性=96.58%）。
FilmArray ME 检测法是一种快速可靠的诊断工具，可用于管理感染性脑膜炎，并且可以轻松地纳入常规诊断工作流程。然而，测试结果与潜在临床症状的相关性需要有经验的用户，并意识到潜在的假阴性或假阳性结果。此外，考虑到需要进行抗菌药物敏感性测试，不能推荐将分子测试作为单一诊断方法使用。
