Department of Pediatrics, Faculty of Medicine, Menoufia University, Menoufia, Egypt.
Department of Clinical Pathology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.
Ann Med. 2022 Dec;54(1):1725-1731. doi: 10.1080/07853890.2022.2091789.
Sepsis is a life-threatening condition associated with high morbidity and mortality rates among neonates. Clinical diagnosis is limited due to the neonates' unspecific signs and symptoms as well as the long time required to obtain the blood culture results. Consequently, there is an urgent need for new biomarkers to early diagnose neonatal sepsis. We aimed to evaluate Neutrophil Gelatinase-Associated Lipocalin (NGAL) diagnostic performance to detect neonatal sepsis. We enrolled 30 neonates with sepsis admitted to the neonatal intensive care units and 30 age- and sex-matched healthy neonates recruited from the neonatal outpatient clinic during their routine follow-up visits. We measured NGAL levels by sandwich enzyme-linked immunosorbent assay, the C-reactive protein (CRP) with nephelometry technique using BN II nephelometer, and the complete blood count by Mindray BC-6800 analysers. NGAL, CRP, TLC, haemoglobin, and platelet levels showed significant differences between cases and control (all < .001). Of the 30 neonates with sepsis, 17 neonates (56.7%) survived. At 0 h, the NGAL level showed no statistically significant difference between the non-survivors and survivors' groups; however, after 96 h, NGAL was significantly higher in the non-survivors group ( ˂ .001). Our diagnostic analysis showed that NGAL levels have strong discrimination power to early differentiate neonates with sepsis; at the 475.00 pg/ml cut-off value, NGAL showed both sensitivity and specificity of 100% with an area under curve of 100%. Our study suggests that NGAL could be a promising biomarker for neonatal sepsis detection. Further studies with larger sample sizes and survival analysis are warranted to confirm this finding and to clarify the efficacy of NGAL in survival prediction. Key findingsNGAL level was high in neonates with sepsisNGAL level was high in non-survived neonatesNGAL could be a promising diagnostic marker for sepsis.
败血症是一种危及生命的疾病，与新生儿的高发病率和死亡率有关。由于新生儿的非特异性体征和症状以及获得血培养结果所需的时间较长，临床诊断受到限制。因此，迫切需要新的生物标志物来早期诊断新生儿败血症。我们旨在评估中性粒细胞明胶酶相关脂质运载蛋白（NGAL）对诊断新生儿败血症的诊断性能。我们招募了 30 名患有败血症的新生儿重症监护病房患儿和 30 名年龄和性别匹配的健康新生儿，他们在常规随访期间从新生儿门诊就诊。我们通过夹心酶联免疫吸附试验测量 NGAL 水平，使用 BN II 散射浊度计通过比浊法测量 C 反应蛋白（CRP），并使用 Mindray BC-6800 分析仪测量全血细胞计数。NGAL、CRP、TLC、血红蛋白和血小板水平在病例组和对照组之间存在显著差异（均<0.001）。在 30 名患有败血症的新生儿中，有 17 名新生儿（56.7%）存活。在 0 小时，非存活组和存活组的 NGAL 水平没有统计学差异；然而，在 96 小时后，非存活组的 NGAL 水平显著升高（<0.001）。我们的诊断分析表明，NGAL 水平具有很强的区分能力，可以早期区分患有败血症的新生儿；在 475.00pg/ml 截止值下，NGAL 的敏感性和特异性均为 100%，曲线下面积为 100%。我们的研究表明，NGAL 可能是一种有前途的新生儿败血症检测生物标志物。需要进一步进行更大样本量的研究和生存分析，以确认这一发现，并阐明 NGAL 在生存预测中的疗效。主要发现败血症新生儿的 NGAL 水平升高非存活新生儿的 NGAL 水平升高NGAL 可能是一种有前途的败血症诊断标志物。
