SERUM Β-D-GLUCAN AS AN EARLY DIAGNOSTIC BIOMARKER FOR INVASIVE FUNGAL INFECTION IN NEONATES ADMITTED TO A TERTIARY-LEVEL NEONATAL INTENSIVE CARE UNIT: A PROSPECTIVE OBSERVATIONAL STUDY
Authors: Anukrati Sharma, Manisha Thakur, Prakash C. Medatwal, Anil Galwa, Rakesh Maheshwari
Publication Date: 2026/05/14
DOI: 10.59551/DOI: 10.59551/IJHMP/25832069/2026.7.1.120
Abstract
<p>Background: Invasive fungal infections (IFIs) are a significant cause of late-onset sepsis in neonatal intensive care units (NICUs), with mortality rates of 30%–60% in affected neonates. Conventional blood culture is limited by poor sensitivity and prolonged turnaround times. Serum (1→3)-β-D-glucan (BDG), a conserved pan-fungal cell wall polysaccharide, has emerged as a promising non-culture biomarker; however, its diagnostic performance in neonatal populations remains incompletely characterised.</p>
<p>Objective: To evaluate the diagnostic accuracy of serum β-D-glucan for early identification of invasive fungal infection in high-risk neonates admitted to a tertiary-level NICU.</p>
<p>Methods: A prospective observational study was conducted over 18 months in the NICU of a tertiary academic hospital. Thirty neonates with clinically suspected late-onset sepsis (>72 h after birth) and ≥3 predefined IFI risk factors were enrolled. Serum BDG was quantified using the Fungitell® colorimetric assay (Associates of Cape Cod Inc., USA) based on the Limulus Amebocyte Lysate (LAL) reaction. Automated BACTEC blood cultures served as the reference standard. A BDG cutoff of ≥80 pg/mL was applied. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy were calculated using IBM SPSS v26.0.</p>
<p>Results: Of 30 neonates enrolled, 12 (40%) had confirmed IFI and 18 (60%) did not. Mean serum BDG was markedly higher in the IFI group (186.4 ± 52.8 pg/mL) than in the non-IFI group (48.6 ± 15.2 pg/mL; p <0.001). At the ≥80 pg/ mL threshold, BDG demonstrated sensitivity of 83.3%, specificity of 83.3%, PPV of 76.9%, NPV of 88.2%, and overall diagnostic accuracy of 83.3%. Baseline demographic parameters were comparable between groups (all p >0.05); SpO₂ alone differed significantly (p = 0.02), attributed to greater respiratory support in the infected cohort.</p>
<p>Conclusion: Serum β-D-glucan demonstrates robust sensitivity, specificity, and negative predictive value for early detection of IFI in neonates. Integration into routine NICU sepsis workups may facilitate timely antifungal therapy and improved neonatal outcomes. Prospective multicentre studies are required to validate neonatal-specific cutoffs.</p>
<p>KEYWORDS: β-D-glucan, Invasive Fungal Infection, Neonatal Sepsis, NICU, Candida, Diagnostic Biomarker, Fungitell Assay, Neonatal Candidiasis, Non-culture Diagnostics, Diagnostic Accuracy.</p>
References
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