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This is a Literature Review study.

November 8, 2025Open Access

Diagnostic Markers of Neonatal Sepsis

SSShambhavi SharanIndira Gandhi Institute of Medical Sciences RKRajeev Ranjan KumarHemwati Nandan Bahuguna Garhwal University RKRekha KumariLiaquat University of Medical & Health Sciences

Key Points

Novel biomarkers like procalcitonin and IL-6 improve the early diagnosis of neonatal sepsis through enhanced specificity.
The review emphasizes the effectiveness of combining traditional and novel diagnostic markers for higher accuracy.
Molecular diagnostics and point-of-care biosensors are revolutionizing neonatal sepsis detection in resource-limited settings.
Support from ICMR is crucial for implementing low-cost diagnostic tests to improve neonatal healthcare outcomes.

Abstract

Background: Neonatal sepsis is a life-threatening condition and a major cause of neonatal morbidity and mortality worldwide, particularly in developing nations like India. Early diagnosis remains a challenge due to nonspecific clinical manifestations and limitations of conventional diagnostic tests. Aim: To review and summarize the current and emerging diagnostic markers of neonatal sepsis, with a focus on their diagnostic accuracy, feasibility, and applicability in the Indian healthcare context. Methods: A comprehensive literature review was conducted using databases such as PubMed, Scopus, Google Scholar, and Web of Science for studies published between 2018 and 2025. Relevant keywords included neonatal sepsis, diagnostic markers, biomarkers, CRP, procalcitonin, IL-6, CD64, and molecular diagnostics. Both traditional and novel markers were evaluated for sensitivity, specificity, and clinical utility. Studies from India were particularly emphasized to highlight region-specific challenges and ICMR-supported research initiatives. Results: Traditional markers like CRP and TLC remain widely used but exhibit low specificity. Novel biomarkers such as procalcitonin, IL-6, IL-8, CD64, presepsin, and neopterin show promising diagnostic potential, especially when used in combination. Recent advances in molecular diagnostics, microRNA profiling, and point-of-care biosensorsoffer rapid and accurate detection capabilities. Conclusion: Combining multiple biomarkers with advanced diagnostic platforms can substantially improve early detection and management of neonatal sepsis. Support from the Indian Council of Medical Research (ICMR) and Government of India in validating and deploying low-cost diagnostic assays is essential to strengthen neonatal healthcare infrastructure. Keywords: Neonatal sepsis, Diagnostic markers, Biomarkers, Procalcitonin, ICMR, India

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