Importance Neonatal early-onset sepsis (EOS) is a severe disease, particularly in preterm infants. Timely diagnosis can be challenging owing to unspecific presentation and questionable performance of the common markers of infection. Presepsin was recently proven to be a promising biomarker for the diagnosis of EOS. Objective To assess presepsin accuracy for the diagnosis of EOS. Data Sources PubMed Medline, EMBASE, Web of Science, and Google Scholar. No publication date restrictions were applied. The literature search was limited to the English language. Articles were checked for duplication. Study Selection Inclusion criteria were studies that (1) included term or preterm newborns (defined as newborns with gestational age ≥37 weeks or <37 weeks, respectively); (2) included a diagnosis of EOS, defined as culture-proven sepsis for primary analysis and as either clinical or culture-proven sepsis for secondary analysis; and (3) assessed presepsin values during the initial workup for suspected EOS. Exclusion criteria were studies that (1) did not include EOS cases; (2) lacked data on presepsin sensitivity and/or specificity; and (3) were case reports, commentaries, or reviews. Two independent reviewers performed the study selection. Data Extraction and Synthesis Two independent reviewers performed data extraction and quality assessment. Quality assessment was performed using the Quality Assessment for Studies of Diagnostic Accuracy 2 tool, and data were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data were pooled using a random-effects model. Main Outcomes and Measures The outcomes of interest for both the primary and secondary analyses were presepsin sensitivity, specificity, and diagnostic odds ratio for the diagnosis of EOS. Results A total of 12 studies of 245 (4.9%) met inclusion criteria for the primary analysis. Twenty-three studies of 245 (9.4%) met the inclusion criteria for the secondary analysis. In the primary analysis, among 12 studies and 828 newborns of any gestational age, pooled sensitivity and specificity were 0.93 (95% CI, 0.86-0.95) and 0.91 (95% CI, 0.85-0.95), respectively; pooled diagnostic odds ratio was 131.69 (95% CI, 54.93-310.94). Subgroup analysis showed that presepsin specificity was associated with the inclusion of only EOS or all neonatal sepsis. Presepsin accuracy was not associated with gestational age, measurement with chemiluminescence enzyme immunoassay or enzyme-linked immunosorbent assay testing, country where the study was performed, or risk of bias judgment. In the secondary analysis, among 23 studies and 1866 newborns, accuracy was significantly associated with only test type. Conclusions and Relevance Results of this systematic review and meta-analysis suggest that presepsin was an accurate biomarker of EOS. Clinical trials are warranted to assess its usefulness and safety to reduce early antibiotic exposure, particularly in preterm newborns.

中文翻译：

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Presepsin 用于诊断新生儿早发性脓毒症：系统评价和荟萃分析。


重要性 新生儿早发性败血症 (EOS) 是一种严重的疾病，尤其是早产儿。由于常见感染标志物的表现不具体且表现可疑，及时诊断可能具有挑战性。 Presepsin 最近被证明是一种有前途的 EOS 诊断生物标志物。目的 评估 presepsin 诊断 EOS 的准确性。数据来源 PubMed Medline、EMBASE、Web of Science 和 Google Scholar。没有发布日期限制。文献检索仅限于英语。检查文章是否重复。研究选择纳入标准为以下研究：(1) 纳入足月或早产新生儿（分别定义为胎龄≥37 周或<37 周的新生儿）； (2) 包括 EOS 的诊断，定义为用于初步分析的经培养证实的脓毒症，以及用于二次分析的临床或经培养证实的脓毒症； (3) 在疑似 EOS 的初始检查过程中评估 presepsin 值。排除标准是以下研究：(1) 不包括 EOS 病例； (2) 缺乏有关 presepsin 敏感性和/或特异性的数据； (3) 是案例报告、评论或评论。两名独立评审员进行了研究选择。数据提取和综合 两名独立评审员进行数据提取和质量评估。使用诊断准确性研究质量评估 2 工具进行质量评估，并根据系统评价和荟萃分析指南的首选报告项目报告数据。使用随机效应模型汇集数据。 主要结果和测量 主要和次要分析的感兴趣结果是 EOS 诊断的 presepsin 敏感性、特异性和诊断比值比。结果 共有 12 项研究，共 245 项 (4.9%) 符合主要分析的纳入标准。 245 项研究中的 23 项（9.4%）符合二次分析的纳入标准。在主要分析中，在 12 项研究和 828 名任何胎龄的新生儿中，汇总敏感性和特异性分别为 0.93 (95% CI, 0.86-0.95) 和 0.91 (95% CI, 0.85-0.95)；汇总诊断优势比为 131.69（95% CI，54.93-310.94）。亚组分析表明 presepsin 特异性与仅纳入 EOS 或所有新生儿败血症相关。 Presepsin 的准确性与胎龄、化学发光酶免疫分析或酶联免疫吸附分析测试的测量结果、研究进行的国家或偏倚判断风险无关。在 23 项研究和 1866 名新生儿的二次分析中，准确性仅与测试类型显着相关。结论和相关性 本系统评价和荟萃分析的结果表明 presepsin 是 EOS 的准确生物标志物。有必要进行临床试验来评估其有效性和安全性，以减少早期抗生素暴露，特别是在早产新生儿中。