BACKGROUND Early diagnosis of bacterial sepsis in neonates is hampered by non-specific symptoms and the lack of rapid responding laboratory measures. The biomarker soluble CD14 subtype (sCD14-ST) seems promising in the diagnostic process of neonatal sepsis. In order to evaluate the differences in diagnostic accuracy of sCD14-ST between early onset sepsis (EOS) and late onset sepsis (LOS) we assessed this systematic review and meta-analysis. RESULTS Twelve articles were included in the systematic review and 10 in the meta-analysis. There was a high risk of bias on patient selection, index test and/or flow and timing. The overall quality of the included studies was moderate. At sepsis onset a consequently higher level of sCD14-ST was found in septic neonates compared to healthy controls with significant higher levels in LOS compared to EOS. In the first 24 h after sepsis onset a significant increase in pooled means of plasma sCD14-ST levels was seen in EOS (t(71.6) = 7.3, p < .0001) while this was not seen in LOS or healthy controls. Optimal cut-off values ranged from 305 to 672 ng/l for EOS cases versus healthy controls. The pooled sensitivity was 81% (95%CI: 0.76-0.85), the pooled specificity was 86% (0.81-0.89) with an AUC of 0.9412 (SE 0.1178). In LOS optimal cut-off values ranged from 801 to 885 ng/l with a pooled sensitivity of 81% (0.74-0.86) and a pooled specificity of 100% (0.98-1.00). An AUC and SROC was not estimable in LOS because of the low number of studies. CONCLUSIONS sCD14-ST is a promising and rapid-responding diagnostic biomarker for EOS and LOS. The difference in pooled means between EOS and LOS underlines the importance to consider EOS and LOS as two different disease entities, requiring separate analysis in original articles and systematic reviews.

中文翻译：

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可溶性CD14亚型（sCD14-ST）作为新生儿早期发作性败血症和晚期发作性败血症的生物标志物：系统评价和荟萃分析。

背景技术非特异性症状和缺乏快速反应的实验室措施阻碍了新生儿细菌性败血症的早期诊断。生物标志物可溶性CD14亚型（sCD14-ST）在新生儿败血症的诊断过程中似乎很有希望。为了评估早发性败血症（EOS）和晚发性败血症（LOS）之间sCD14-ST诊断准确性的差异，我们评估了该系统评价和荟萃分析。结果系统评价包含12篇文章，荟萃分析包含10篇文章。在患者选择，指标测试和/或流程和时间安排上存在偏见的高风险。纳入研究的总体质量中等。败血症发作后，败血性新生儿的sCD14-ST水平高于健康对照组，而LOS的水平明显高于EOS。脓毒症发作后的最初24小时内，在EOS中发现血浆sCD14-ST的合并平均值显着增加（t（71.6）= 7.3，p <.0001），而在LOS或健康对照中则未观察到。与健康对照组相比，EOS病例的最佳临界值范围为305至672 ng / l。合并的敏感性为81％（95％CI：0.76-0.85），合并的特异性为86％（0.81-0.89），AUC为0.9412（SE 0.1178）。在LOS中，最佳临界值范围为801至885 ng / l，合并灵敏度为81％（0.74-0.86），特异性为100％（0.98-1.00）。由于研究数量少，在LOS中不能估计AUC和SROC。结论sCD14-ST是用于EOS和LOS的有前途和快速反应的诊断生物标志物。