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Abstract：
rRNA gene Sanger sequencing is being used for the identification of cultured pathogens. A new diagnostic approach is sequencing of uncultured samples by using the commercial DNA extraction and sequencing platform SepsiTest (ST). The goal was to analyze the clinical performance of ST with a focus on nongrowing pathogens and the impact on antibiotic therapy. A literature search used PubMed/Medline, Cochrane, Science Direct, and Google Scholar. Eligibility followed PRISMA-P criteria. Quality and risk of bias were assessed drawing on QUADAS-2 (quality assessment of diagnostic accuracy studies, revised) criteria. Meta-analyses were performed regarding accuracy metrics compared to standard references and the added value of ST in terms of extra found pathogens. We identified 25 studies on sepsis, infectious endocarditis, bacterial meningitis, joint infections, pyomyositis, and various diseases from routine diagnosis. Patients with suspected infections of purportedly sterile body sites originated from various hospital wards. The overall sensitivity (79%; 95% confidence interval [CI], 73 to 84%) and specificity (83%; 95% CI, 72 to 90%) were accompanied by large effect sizes. ST-related positivity was 32% (95% CI, 30 to 34%), which was significantly higher than the culture positivity (20%; 95% CI, 18 to 22%). The overall added value of ST was 14% (95% CI, 10 to 20%) for all samples. With 130 relevant taxa, ST uncovered high microbial richness. Four studies demonstrated changes of antibiotic treatment at 12% (95% CI, 9 to 15%) of all patients upon availability of ST results. ST appears to be an approach for the diagnosis of nongrowing pathogens. The potential clinical role of this agnostic molecular diagnostic tool is discussed regarding changes of antibiotic treatment in cases where culture stays negative.
摘要：
rRNA基因Sanger测序用于鉴定培养的病原体。一种新的诊断方法是通过使用商业DNA提取和测序平台SepsiTest（ST）对未培养的样品进行测序。目的是分析ST的临床表现，重点是不生长的病原体以及对抗生素治疗的影响。使用PubMed/Medline进行文献检索，科克伦,科学直接，谷歌学者。资格符合PRISMA-P标准。使用QUADAS-2（诊断准确性研究的质量评估，修订)标准。进行了关于与标准参考相比的准确性指标以及ST在额外发现的病原体方面的附加值的荟萃分析。我们确定了25项关于脓毒症的研究，感染性心内膜炎,细菌性脑膜炎,关节感染,化脓性肌炎,以及常规诊断的各种疾病。怀疑感染据称无菌身体部位的患者来自各个医院病房。总体灵敏度(79%；95%置信区间[CI]，73至84％）和特异性（83％；95％CI，72至90％）伴随着较大的效应大小。ST相关阳性率为32%(95%CI，30-34%)，显着高于培养阳性（20％；95％CI，18至22％）。对于所有样品,ST的总附加值为14%(95%CI,10至20%)。有130个相关分类单元，ST发现了很高的微生物丰富度。四项研究表明，在获得ST结果后，所有患者的抗生素治疗变化为12％（95％CI，9％至15％）。ST似乎是诊断非生长病原体的一种方法。关于在培养物保持阴性的情况下抗生素治疗的变化，讨论了这种不可知的分子诊断工具的潜在临床作用。
