Infection, Injury and Inflammation Research Group, Biomedical Facility, Clinical Sciences, Manchester Academic Health Sciences Centre, Salford Royal NHS Foundation Trust, Salford, Greater Manchester, M6 8HD, UK,
Intensive Care Med. 2015 Jan;41(1):21-33. doi: 10.1007/s00134-014-3553-8. Epub 2014 Nov 22.
There is an urgent need to develop diagnostic tests to improve the detection of pathogens causing life-threatening infection (sepsis). SeptiFast is a CE-marked multi-pathogen real-time PCR system capable of detecting DNA sequences of bacteria and fungi present in blood samples within a few hours. We report here a systematic review and meta-analysis of diagnostic accuracy studies of SeptiFast in the setting of suspected sepsis.
A comprehensive search strategy was developed to identify studies that compared SeptiFast with blood culture in suspected sepsis. Methodological quality was assessed using QUADAS. Heterogeneity of studies was investigated using a coupled forest plot of sensitivity and specificity and a scatter plot in receiver operator characteristic space. Bivariate model method was used to estimate summary sensitivity and specificity.
From 41 phase III diagnostic accuracy studies, summary sensitivity and specificity for SeptiFast compared with blood culture were 0.68 (95 % CI 0.63-0.73) and 0.86 (95 % CI 0.84-0.89) respectively. Study quality was judged to be variable with important deficiencies overall in design and reporting that could impact on derived diagnostic accuracy metrics.
SeptiFast appears to have higher specificity than sensitivity, but deficiencies in study quality are likely to render this body of work unreliable. Based on the evidence presented here, it remains difficult to make firm recommendations about the likely clinical utility of SeptiFast in the setting of suspected sepsis.
迫切需要开发诊断测试以提高对导致危及生命感染（败血症）的病原体的检测。 SeptiFast 是一种获得 CE 标志的多病原体实时 PCR 系统，能够在数小时内检测出血液样本中存在的细菌和真菌的 DNA 序列。我们在此报告了一项关于 SeptiFast 在疑似败血症中的诊断准确性研究的系统评价和荟萃分析。
制定了一项全面的搜索策略，以确定将 SeptiFast 与血液培养物进行比较的研究。使用 QUADAS 评估方法学质量。使用敏感性和特异性的耦合森林图和接收器操作特性空间中的散点图来研究研究之间的异质性。使用双变量模型方法估算汇总敏感性和特异性。
从 41 项 III 期诊断准确性研究中，与血液培养相比，SeptiFast 的汇总敏感性和特异性分别为 0.68（95%CI 0.63-0.73）和 0.86（95%CI 0.84-0.89）。研究质量总体上被判断为可变的，在设计和报告方面存在重要缺陷，这可能会影响衍生的诊断准确性指标。
SeptiFast 的特异性似乎高于敏感性，但研究质量的缺陷可能使这项工作不可靠。基于这里提出的证据，仍然难以对 SeptiFast 在疑似败血症中的临床应用价值做出明确的建议。
