Assessing the diagnostic potential of 16SrRNA gene for neonatal sepsis: A tertiary care hospital study in South India.

Background: The need of the hour is to incorporate a rapid assay that could efficiently detect neonatal sepsis. We evaluated the diagnostic utility of 16SrRNA broad-range polymerase chain reaction (PCR) in neonatal sepsis. Methods: The demographic and clinical details of 100 neonates clinically suspected to have sepsis were collected adopting pretested clinical proforma, followed by baseline laboratory investigations, including blood culture, complete blood counts, and C-reactive protein (CRP). Around, 0.2-0.3 ml of the EDTA blood was subjected to enrichment followed by DNA isolation using the modified spin column method. Based on the blood culture report, neonates were further divided into the suspected sepsis group (n = 50) and the confirmed sepsis group (n = 50). We performed 16SrRNA broad-range PCR to identify the presence of bacteria, and the results were analyzed statistically using SPSS software. Results: Neonates in both groups were found to have clinical parameters comparable to each other except for birth weight, length, and head circumference, which was found to be lower in the culture-positive group than in culture-negative group (p < 0.05). The diagnosis of neonatal sepsis by 16SrRNA broad-range PCR compared to blood culture revealed 100% sensitivity, 64% specificity, and 73.5% positive and 100% negative predictive value. The 18 cases detected positive by PCR had clinical and other diagnostic findings consistent with sepsis. Conclusion: The 16SrRNA broad-range PCR effectively ruled out sepsis in 32 neonates within 8 h of sample collection compared to blood culture, which took 24 h. The method may not replace blood culture but can be used to complement it.