Validity of procalcitonin and C-reactive protein as biomarkers in diagnosis of neonatal sepsis in a referral hospital, Kenya

Abstract

Background: Neonatal sepsis (NS) is a signifcant health concern causing high morbidity and mortality among neonates. The clinical symptoms of NS can overlap with other common neonatal conditions. The gold standard diagnostic method, the blood culture test, has numerous limitations including lengthy turnaround time, which delays appropriate management of NS. Acute phase protein; procalcitonin (PCT) and C-reactive protein (CRP) tests have emerged as potential alternatives due to short turnaround times, high sensitivity, and specifcity in detecting NS. Nevertheless, there is limited data on their usability in Kenyan public hospitals. This study, therefore, was conducted to validate the performance of PCT and CRP tests in diagnosis of NS locally. Methodology: Blood samples were collected from 196 neonates with suspected sepsis admitted at Moi Teaching and Referral Hospital (MTRH). Blood culture was performed using BacT/ALERT blood culture system. Bacteria growths were identifed and antibiotic susceptibility for the isolates determined using Vitek II. Serum PCT levels were determined using the chemiluminescence immunoassay method. Serum CRP levels were measured using Immunoturbidimetry method. Results: Growth of organisms occurred in 45.4% of the sepsis suspected neonates. The sensitivity, specifcity, positive predictive value, negative predictive value and area under the curve for PCT were 93.3%, 98.1%, 97.6%, 94.6% and 0.959, whereas for CRP they were 100%, 72.8%, 74.3%, 100%, and 0.953, respectively. Conclusion and Recommendation: The CRP test exhibited superior sensitivity, negative predictive value, but lower specifcity, making it a more valuable tool for ruling out NS. Overall, however, PCT emerged as a more robust biomarker, offering a reliable balance between sensitivity and specifcity, indicating its ability to identify cases with NS correctly. The area under the ROC curve confrms that CRP and PCT have high accuracy in detecting NS. The study recommends adoption of PCT and CRP biomarkers in the diagnostic protocols for NS