评价 BioFire® FilmArray® 脑膜炎/脑炎检测 panel 在乌干达成人和儿童人群中的应用。
Evaluation of the BioFire® FilmArray® Meningitis/Encephalitis panel in an adult and pediatric Ugandan population.
机构信息
Mbarara University of Science and Technology, P.O Box 1410, Mbarara, Uganda; University of Minnesota, 689 23rd Ave SE, Minneapolis 55455, MN, United States; University of Virginia, Charlottesville, VA, United States.
University of Minnesota, 689 23rd Ave SE, Minneapolis 55455, MN, United States.
出版信息
J Mycol Med. 2021 Sep;31(3):101170. doi: 10.1016/j.mycmed.2021.101170. Epub 2021 Jun 24.
BACKGROUND
Meningitis causes significant mortality in sub-Saharan Africa and limited diagnostics exist. We evaluated the utility of the BioFire® FilmArray® Meningitis/Encephalitis multiplex PCR panel (BioFire ME) in HIV-infected adults and HIV-infected and uninfected children presenting with suspected meningitis in Uganda.
METHODS
We tested cerebrospinal fluid (CSF) using a stepwise meningitis diagnostic algorithm including BioFire ME. We determined the diagnostic performance of BioFire ME for cryptococcal meningitis, using cryptococcal antigen (CrAg) and CSF culture as reference standards, and assessed other central nervous system (CNS) pathogens identified by the panel.
RESULTS
We evaluated 328 adult and 42 pediatric CSF specimens using BioFire ME. Of the adult CSF samples tested, 258 were obtained at baseline, and 70 were obtained from repeat lumbar punctures in cryptococcal meningitis. For Cryptococcus, sensitivity was 82%, specificity was 98%, PPV was 98%, and NPV was 79% in baseline specimens using CSF CrAg as the reference standard. Among follow-up specimens, a negative BioFire ME for Cryptococcus predicted CSF culture sterility with 84% NPV. Overall sensitivity was decreased at low fungal burdens: 29% for 0-99 Cryptococcus CFU/mL compared to 94% for ≥100 CFU/mL in baseline specimens. Other pathogens detected included E. Coli, H. influenzae, S. pneumoniae, CMV, enterovirus, HSV, HHV-6, and VZV. Two specimens tested positive for S. pneumoniae and one for Cryptococcus in the pediatric population.
CONCLUSIONS
Multiplex PCR is a promising rapid diagnostic test for meningitis in adults and children in resource-limited settings. Cryptococcus at low fungal burdens in CSF may be missed by BioFire ME.
背景
脑膜炎在撒哈拉以南非洲地区导致了大量死亡，但现有的诊断方法有限。我们评估了 BioFire® FilmArray® 脑膜炎/脑炎多重 PCR 检测试剂盒（BioFire ME）在乌干达感染 HIV 的成人及感染和未感染 HIV 的儿童疑似脑膜炎患者中的应用价值。
方法
我们使用包括 BioFire ME 在内的逐步脑膜炎诊断算法对脑脊液（CSF）进行了检测。我们使用隐球菌抗原（CrAg）和 CSF 培养作为参考标准，确定了 BioFire ME 对隐球菌性脑膜炎的诊断性能，并评估了该检测面板识别的其他中枢神经系统（CNS）病原体。
结果
我们使用 BioFire ME 检测了 328 份成人和 42 份儿科 CSF 标本。在检测的成人 CSF 样本中，258 份为基线样本，70 份来自隐球菌性脑膜炎的重复腰椎穿刺样本。使用 CSF CrAg 作为参考标准，对于隐球菌，基线标本的敏感性为 82%，特异性为 98%，PPV 为 98%，NPV 为 79%。在随访标本中，阴性的 BioFire ME 结果对隐球菌 CSF 培养无菌具有 84%的阴性预测值（NPV）。在真菌负荷较低时，总体敏感性降低：基线标本中 0-99 个隐球菌 CFU/mL 时的敏感性为 29%，而≥100 CFU/mL 时的敏感性为 94%。其他检测到的病原体包括大肠杆菌、流感嗜血杆菌、肺炎链球菌、CMV、肠道病毒、单纯疱疹病毒、HHV-6 和 VZV。在儿科人群中，有两份标本检测出肺炎链球菌阳性，一份标本检测出隐球菌阳性。
结论
多重 PCR 是资源有限地区成人和儿童脑膜炎的一种很有前途的快速诊断检测方法。CSF 中真菌负荷较低的隐球菌可能会被 BioFire ME 漏检。
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