Abstract
Background Neonatal septicemia is a critical medical situation; current conventional laboratory methods still have many limitations and diagnostic obstacles. For this purpose, last decades have witnessed a challenge between the battery of sepsis biomarkers including many leukocyte surface antigens, not only for early diagnostic purposes but also for better follow-up and good management of sepsis patients. Aim To evaluate the diagnostic, prognostic, and monitoring performance of both neutrophil CD64 (nCD64) and presepsin as sepsis biomarkers compared to each other and to the conventional laboratory sepsis parameters aiming to decide which is the best fitting for routine daily use in neonatal intensive care units (NICUs). Methods 235 neonates were enrolled from three Egyptian neonatal ICUs, during the period from November 2015 till March 2018; they were classified into two main groups: the control group (n = 102) and the sepsis group (n = 133). Laboratory sepsis evaluation included highly sensitive CRP (hs-CRP), CBC, in addition to nCD64 (flow cytometry technique), and presepsin measurement (CLEIA technique combined with Magtration® technology); the diagnosis was confirmed thereafter by positive blood culture results (BacT/Alert system). Sixty-two of the enrolled sepsis neonates were subjected to follow-up assessment; they were reclassified according to their clinical improvement at the second time assessment into (group 1: sepsis group without improvement) (n = 20) and (group 2: improved sepsis group) (n = 42). Results Significant increase in nCD64 and presepsin values was found in sepsis groups compared to the controls. At cutoff 41.6%, nCD64% could discriminate the presence of septicemia with sensitivity 94.7%, specificity 93.6 %, and AUC 0.925, while presepsin at cutoff 686 pg/ml achieves sensitivity 82.7%, specificity 95.5%, and AUC 0.887, respectively. Significant increase in nCD64 (P < 0.001) and hs-CRP (P=0.018) values was observed in severe sepsis/septic shock patients compared to nonsevere sepsis patients. Delta change percentage (dC%) between initial and follow-up evaluations for both improved and nonimproved sepsis patients was dC Z value −5.904 for nCD64% followed by dC Z value −4.494 for presepsin. Conclusion nCD64 and presepsin are valuable early diagnostic and monitoring sepsis biomarkers; the highest sensitivity could be achieved by a univariant sepsis marker in this study was recorded by the nCD64% biomarker, while the highest specificity was documented by presepsin. Combined measurement of both achieves the highest diagnostic performance in sepsis neonates. Either of CD64 or presepsin combined with hs-CRP associated with better performance than any of them alone. nCD64 carries an additional promising role in reflecting sepsis prognosis.
Highlights
Ey were categorized into two main groups: control group (n 102) and sepsis group (n 133); control group was subdivided into healthy controls (n 53) and diseased controls (n 49), while sepsis patients were subdivided into two subgroups: documented sepsis patients (n 65) and clinical sepsis patients (n 68)
Blood culture was positive in 48.8% of all septic neonates; Klebsiella was the most common microorganism isolated from neonatal intensive care units (NICUs) sepsis patients (n 19, 14.28%) followed by coagulase-negative Staphylococci (CoNS) (n 15, 11.27%) followed by more than monomicrobial infection (n 11, 8.27%); other microorganisms are less commonly encountered in our NICUs including Candida spp. (n 9, 6.76%), Acinetobacter (n 4, 3%), E. coli (n 3, 2.25%), Streptococcus spp. (n 3, 2.25%), and Pseudomonas (n 1, 0.75%) (Figure 1)
Neutrophil CD64 and presepsin biomarkers are significantly higher in sepsis patients than the controls, suggesting their potential use for early diagnosis of Neonatal sepsis (NS) in routine clinical situations
Summary
Neonatal sepsis (NS) is an important cause of neonatal morbidities and mortalities worldwide [1, 2]; the overall incidence of NS ranges from 1 to 5 cases per 1,000 live births in developed countries, comparable to 49–170 per 1,000 live births in developing countries, with case fatality rates ranging from 2% to 60% [3, 4].In Egypt, around 80% of early childhood deaths take place during the first year of life, with over half occurringInternational Journal of Microbiology during the first month of life. e neonatal mortality rates were documented as 14 deaths per 1,000 births [5].Early diagnosis of sepsis is a clinical challenge as clinical symptoms and signs of the disease are subtle, late, and nonspecific making it hard to be discriminated from that of noninfectious causes [6]. Neonatal septicemia is a critical medical situation; current conventional laboratory methods still have many limitations and diagnostic obstacles. For this purpose, last decades have witnessed a challenge between the battery of sepsis biomarkers including many leukocyte surface antigens, for early diagnostic purposes and for better follow-up and good management of sepsis patients. Aim. To evaluate the diagnostic, prognostic, and monitoring performance of both neutrophil CD64 (nCD64) and presepsin as sepsis biomarkers compared to each other and to the conventional laboratory sepsis parameters aiming to decide which is the best fitting for routine daily use in neonatal intensive care units (NICUs). Laboratory sepsis evaluation included highly sensitive CRP (hs-CRP), CBC, in addition to nCD64 (flow cytometry technique), and presepsin
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