The C-Reactive Protein/Albumin Ratio As An Early Diagnostic Marker Of Neonatal Sepsis In Preterm Neonates: A Case-Control Study

Dina K Khedr, Samar Nabil, Asmaa Abdelnaby, Abdulrahman A Abdulrazek, Sohilla Lotfy
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Abstract

: Background: Neonatal sepsis is a serious systemic infection that might be fatal. Early diagnosis is challenging. The c-reactive protein (CRP)/albumin ratio is a promising biomarker that may help with early diagnosis and timely management of sepsis. Aim of the work: to study the sensitivity and specificity of the CRP/albumin ratio as a diagnostic marker of neonatal sepsis in preterm newborns. Patients and Methods: in this case-control study CRP/albumin ratio was estimated in 154 preterm newborns admitted to Neonatal Intensive Care Units (NICUs) of Cairo University Children's Hospitals. They were divided into 2 groups. Group (I), the sepsis group “based on positive blood culture” (n=54), and group (II), a control group, with no clinical signs or laboratory evidence of sepsis (n=100). Results: The mean age of newborns in the sepsis group was 3 ± 2.5 days vs 4.5 ± 2.5 days for the control group. The sepsis group had a mean ± SD CRP/albumin ratio higher than that of the control group (18.5 ± 20 vs 0.6± 0.7, p= 0.00). 30 (55%) of those in the sepsis group died; they had a mean ± SD CRP/albumin ratio of 20± 21, vs 15 ± 17 for those who survived (p value=0.3). Neonatal Sepsis was best diagnosed by the CRP/albumin ratio above the cutoff value of 1.5 with 100 % sensitivity, 95% specificity, 91.5 % positive predictive value (PPV), 100 % negative predictive value (NPV), (area under the curve (AUC)= 0.99, and 95 % confidence interval (CI) 0.983 - 1), which was not different than that of CRP alone (p=0.800). CRP above the cutoff point of 4.3 showed 96.3 % sensitivity, 96% specificity, 92.9 % PPV, 98 % NPV, (AUC= 0.99 , 95 % CI 0.983 - 1). The I/T ratio (shift to the left) above the cutoff point of 0.2 showed 64.8% sensitivity, 100 % specificity, 100% PPV and 84% NPV (AUC= 0.94 , 95% CI 0.891 - 0.973). Conclusion: CRP/albumin ratio is a highly sensitive and specific early diagnostic biomarker for neonatal sepsis in premature newborns that has marginal superiority to the CRP in the diagnosis of neonatal bacterial sepsis. More studies are needed to validate the sensitivity and specificity of a score that combines both the CRP/ albumin ratio above 1.2 and the I/T ratio above 0.2 in predication of true positive cases and exclusion of the true negative cases.
作为早产儿新生儿败血症早期诊断标志物的 C 反应蛋白/白蛋白比值:病例对照研究
:背景:新生儿败血症是一种可能致命的严重全身感染。早期诊断具有挑战性。c 反应蛋白(CRP)/白蛋白比值是一种很有前景的生物标志物,有助于败血症的早期诊断和及时处理。工作目的:研究 CRP/白蛋白比值作为早产新生儿败血症诊断标志物的敏感性和特异性。患者和方法:在这项病例对照研究中,对开罗大学儿童医院新生儿重症监护室(NICU)收治的 154 名早产新生儿的 CRP/白蛋白比值进行了估计。他们被分为两组。组(I)是 "基于阳性血培养 "的败血症组(人数=54),组(II)是对照组,没有败血症的临床症状或实验室证据(人数=100)。研究结果败血症组新生儿的平均年龄为 3±2.5 天,对照组为 4.5±2.5 天。败血症组 CRP/白蛋白比值的平均值(± SD)高于对照组(18.5± 20 vs 0.6± 0.7,P= 0.00)。败血症组中有 30 人(55%)死亡;他们的平均(± SD)CRP/白蛋白比值为 20± 21,而存活者为 15± 17(P 值=0.3)。新生儿败血症的最佳诊断标准是 CRP/白蛋白比值高于 1.5 的临界值,灵敏度为 100%,特异度为 95%,阳性预测值为 91.5%,阴性预测值为 100%(曲线下面积(AUC)= 0.99,95% 置信区间(CI)为 0.983 - 1),与单纯的 CRP 相比无差异(P=0.800)。CRP 高于 4.3 临界点的敏感性为 96.3%,特异性为 96%,PPV 为 92.9%,NPV 为 98%(AUC= 0.99,95% 置信区间为 0.983 - 1)。I/T 比值(向左移动)超过 0.2 临界点时,灵敏度为 64.8%,特异性为 100%,PPV 为 100%,NPV 为 84%(AUC= 0.94,95% CI 0.891 - 0.973)。结论CRP/白蛋白比值是早产新生儿败血症高度敏感和特异的早期诊断生物标志物,在诊断新生儿细菌性败血症方面略优于CRP。在预测真正的阳性病例和排除真正的阴性病例方面,还需要更多的研究来验证结合 CRP/ 白蛋白比值高于 1.2 和 I/T 比值高于 0.2 的评分的灵敏度和特异性。
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