Infection in neonates continues to be a global problem with significant morbidity and mortality. The diagnosis of
neonatal sepsis is complicated by nonspecific clinical symptomatology, a high-false negative rate, and a delay in obtaining blood culture results. An ideal
biomarker needs to have a high degree of accuracy in recognizing the presence or absence of definite
infection at an early stage, to guide the initiation and duration of
antibiotic therapy. The diagnostic utility of the following
biomarkers seems to be most practical in the early (
interleukin [IL]-6, IL-8,
tumor necrosis factor-alpha, neutrophil CD64), mid (
procalcitonin) and late (
C-reactive protein) phases of
neonatal sepsis. Future research studies to assess reliability of these
biomarkers should be (1) adequately powered for sample size and (2) use the gold-standard definition of blood-culture proven pathogen-specific
sepsis. Significant advances in diagnostic accuracy of novel
biomarkers to allow early, accurate, and cost-effective identification of pathogens responsible for
neonatal sepsis is anticipated in the next 5 years.