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商业实时 PCR 面板与常规实验室方法在脑膜炎-脑炎诊断中的比较。

Comparison of a commercial real-time PCR panel to routine laboratory methods for the diagnosis of meningitis-encephalitis.

机构信息

Department of Clinical Microbiology, ACT Pathology, Canberra Hospital, Garran, ACT, Australia.

Department of Clinical Microbiology, ACT Pathology, Canberra Hospital, Garran, ACT, Australia; Department of Infectious Diseases, Canberra Hospital, Garran, ACT, Australia; Australian National University Medical School, Canberra Hospital, Canberra, ACT, Australia.

出版信息

Pathology. 2021 Aug;53(5):635-638. doi: 10.1016/j.pathol.2020.09.029. Epub 2021 Jan 17.

DOI:10.1016/j.pathol.2020.09.029
PMID:33472744
Abstract

Meningitis-encephalitis can range from a mild, self limiting illness to a life threatening disease. Rapid microbial diagnosis allows for early targeted management. This study aimed to compare the BioFire FilmArray Meningitis/Encephalitis multiplex PCR panel (ME panel) to traditional testing algorithms for accuracy and turnaround time in the diagnosis of meningitis-encephalitis. From April to November 2018, cerebrospinal fluid (CSF) samples meeting existing laboratory testing criteria for suspected community acquired meningitis-encephalitis were tested on the ME panel and by routine laboratory methods. The methods were compared for accuracy of diagnosis and turnaround time. Where an organism was not identified, the study investigators came to a consensus on whether an infective aetiology was likely based on CSF parameters, clinical features, management and final discharge diagnosis. A total of 147 CSF samples met criteria for testing. Results were concordant in 143 (97%) of cases, including 27 samples where the same organism was identified by both methods. Of the four discordant samples, three organisms identified by the ME panel alone were considered clinically insignificant. One sample, which was culture and antigen positive for Cryptococcus neoformans, was not detected on the ME panel. The ME panel and routine methods identified an organism in 55% and 58% of clinically compatible cases of infection, respectively. The median turnaround time for the ME panel was 2.9 hours, compared to 21.1 hours for routine testing. The ME panel showed high concordance with traditional testing, simplified laboratory workflow, and significantly reduced turnaround time. The failure of the ME panel to detect Cryptococcus spp. is concerning. When cryptococcal meningitis is suspected, we would recommend using culture and cryptococcal antigen testing as the investigations of choice. Despite the availability of molecular assays targeting the common causes of CNS infection, the diagnostic yield remains suboptimal.

摘要

脑膜炎-脑炎的范围从轻度、自限性疾病到危及生命的疾病不等。快速的微生物诊断可以实现早期靶向管理。本研究旨在比较 BioFire FilmArray 脑膜炎/脑炎多重 PCR 检测试剂盒(ME 检测试剂盒)与传统检测方法在诊断脑膜炎-脑炎方面的准确性和周转时间。2018 年 4 月至 11 月,对符合社区获得性脑膜炎-脑炎现行实验室检测标准的脑脊液(CSF)样本进行 ME 检测试剂盒和常规实验室方法检测。比较了两种方法在诊断准确性和周转时间方面的差异。对于未鉴定出病原体的样本,研究人员根据 CSF 参数、临床特征、管理和最终出院诊断,就感染病因是否可能达成共识。共有 147 份 CSF 样本符合检测标准。在 143 例(97%)病例中结果一致,包括 27 例两种方法均鉴定出相同病原体的样本。在 4 例不一致的样本中,ME 检测试剂盒单独鉴定出的 3 种病原体被认为临床意义不大。一种被新型隐球菌培养和抗原检测阳性的样本未被 ME 检测试剂盒检出。ME 检测试剂盒和常规方法分别在 55%和 58%临床疑似感染病例中鉴定出病原体。ME 检测试剂盒的中位周转时间为 2.9 小时,而常规检测为 21.1 小时。ME 检测试剂盒与传统检测方法具有高度一致性,简化了实验室工作流程,显著缩短了周转时间。ME 检测试剂盒未能检测出新型隐球菌令人担忧。当怀疑隐球菌性脑膜炎时,我们建议使用培养和隐球菌抗原检测作为首选检查方法。尽管存在针对中枢神经系统感染常见病原体的分子检测方法,但诊断率仍不理想。

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