PDF(Pubmed)
Abstract：
BACKGROUND: The FilmArray Meningitis/Encephalitis(FA/ME) panel brings benefits in clinical practice, but its diagnostic test accuracy (DTA) remains unclear. We aimed to determine the DTA of FA/ME for the aetiological diagnostic in patients with suspected central nervous system(CNS) infection.
METHODS: We performed a systematic review with DTA meta-analysis (PROSPERO: CRD42020139285). We searched Embase, Medline (Ovid), and Web of Science from inception until September 1st, 2021. We assessed the study-level risk of bias with the QUADAS-2 tool and applied the GRADE approach to assess the certainty of the synthesised evidence. We included studies that simultaneously measured the reference test (CSF/blood culture for bacteria, and specific polymerase chain reaction for viruses) and the FA/ME in patients with suspected CNS infection. We performed random-effects bivariate meta-analysis models of combined sensitivity and specificity using CSF/blood cultures(reference test 1) and a final diagnosis adjudication based on clinical/laboratory criteria (reference test 2).
RESULTS: We included 19 studies (11,351 participants). For all bacteria with reference test 1 (16 studies/6183 patients) sensitivity was estimated at 89·5% (95%CI 81·1-94·4), and specificity at 97·4% (95%CI 94-98·9). With reference test 2 (15 studies/5,524 patients), sensitivity was estimated at 92·1%(95%CI 86·8-95·3) and specificity at 99.2(95%CI 98·3-99·6) For herpes simplex virus-2(HSV-2), enteroviruses, and Varicella-Zoster virus (VZV), we obtained sensitivities between 75·5 and 93·8%, and specificities above 99% (reference test 1). Certainty of the evidence was low.
CONCLUSIONS: FA/ME may have acceptable-to-high sensitivities and high specificities for identifying bacteria, especially for S.pneumoniae, and viruses, especially for HSV-2, and enteroviruses. Sensitivities for L.monocytogenes, H.influenzae, E.coli, and HSV-1 were suboptimal.
BACKGROUND: None.
METHODS: We performed a systematic review with DTA meta-analysis (PROSPERO: CRD42020139285). We searched Embase, Medline (Ovid), and Web of Science from inception until September 1st, 2021. We assessed the study-level risk of bias with the QUADAS-2 tool and applied the GRADE approach to assess the certainty of the synthesised evidence. We included studies that simultaneously measured the reference test (CSF/blood culture for bacteria, and specific polymerase chain reaction for viruses) and the FA/ME in patients with suspected CNS infection. We performed random-effects bivariate meta-analysis models of combined sensitivity and specificity using CSF/blood cultures(reference test 1) and a final diagnosis adjudication based on clinical/laboratory criteria (reference test 2).
RESULTS: We included 19 studies (11,351 participants). For all bacteria with reference test 1 (16 studies/6183 patients) sensitivity was estimated at 89·5% (95%CI 81·1-94·4), and specificity at 97·4% (95%CI 94-98·9). With reference test 2 (15 studies/5,524 patients), sensitivity was estimated at 92·1%(95%CI 86·8-95·3) and specificity at 99.2(95%CI 98·3-99·6) For herpes simplex virus-2(HSV-2), enteroviruses, and Varicella-Zoster virus (VZV), we obtained sensitivities between 75·5 and 93·8%, and specificities above 99% (reference test 1). Certainty of the evidence was low.
CONCLUSIONS: FA/ME may have acceptable-to-high sensitivities and high specificities for identifying bacteria, especially for S.pneumoniae, and viruses, especially for HSV-2, and enteroviruses. Sensitivities for L.monocytogenes, H.influenzae, E.coli, and HSV-1 were suboptimal.
BACKGROUND: None.
摘要：
背景：FilmArray脑膜炎/脑炎（FA/ME）小组在临床实践中带来了好处，但其诊断测试准确性（DTA）仍不清楚。我们旨在确定FA/ME的DTA，用于疑似中枢神经系统（CNS）感染患者的病因诊断。
方法：我们使用DTA荟萃分析进行了系统评价（PROSPERO：CRD42020139285）。我们搜查了Embase,Medline(Ovid),和WebofScience从成立到9月1日，2021年。我们使用QUADAS-2工具评估了研究级别的偏倚风险，并应用GRADE方法评估了综合证据的确定性。我们包括同时测量参考测试的研究（CSF/血液培养细菌，以及病毒的特异性聚合酶链反应）和疑似CNS感染患者的FA/ME。我们使用CSF/血液培养物（参考测试1）和基于临床/实验室标准的最终诊断裁定（参考测试2）进行了组合敏感性和特异性的随机效应双变量荟萃分析模型。
结果：我们纳入了19项研究（11,351名参与者）。对于具有参考测试1（16项研究/6183名患者）的所有细菌，敏感性估计为89·5％（95CI81·1-94·4），特异性为97·4%（95CI94-98·9）。参考测试2（15项研究/5,524名患者），对于单纯疱疹病毒2（HSV-2），敏感性估计为92·1%（95CI86·8-95·3），特异性为99.2（95CI98·3-99·6），肠病毒,水痘-带状疱疹病毒（VZV），我们获得的灵敏度在75·5和93·8%之间，和超过99%的特异性（参考测试1）。证据的确定性很低。
结论：FA/ME可能对鉴定细菌具有可接受的至高的敏感性和高特异性，尤其是肺炎链球菌,和病毒，特别是对于HSV-2和肠道病毒。对单核细胞增生性弧菌的敏感性,流感嗜血杆菌,大肠杆菌,HSV-1次优。
背景：无。
方法：我们使用DTA荟萃分析进行了系统评价（PROSPERO：CRD42020139285）。我们搜查了Embase,Medline(Ovid),和WebofScience从成立到9月1日，2021年。我们使用QUADAS-2工具评估了研究级别的偏倚风险，并应用GRADE方法评估了综合证据的确定性。我们包括同时测量参考测试的研究（CSF/血液培养细菌，以及病毒的特异性聚合酶链反应）和疑似CNS感染患者的FA/ME。我们使用CSF/血液培养物（参考测试1）和基于临床/实验室标准的最终诊断裁定（参考测试2）进行了组合敏感性和特异性的随机效应双变量荟萃分析模型。
结果：我们纳入了19项研究（11,351名参与者）。对于具有参考测试1（16项研究/6183名患者）的所有细菌，敏感性估计为89·5％（95CI81·1-94·4），特异性为97·4%（95CI94-98·9）。参考测试2（15项研究/5,524名患者），对于单纯疱疹病毒2（HSV-2），敏感性估计为92·1%（95CI86·8-95·3），特异性为99.2（95CI98·3-99·6），肠病毒,水痘-带状疱疹病毒（VZV），我们获得的灵敏度在75·5和93·8%之间，和超过99%的特异性（参考测试1）。证据的确定性很低。
结论：FA/ME可能对鉴定细菌具有可接受的至高的敏感性和高特异性，尤其是肺炎链球菌,和病毒，特别是对于HSV-2和肠道病毒。对单核细胞增生性弧菌的敏感性,流感嗜血杆菌,大肠杆菌,HSV-1次优。
背景：无。
