Clinical utility of using C-reactive protein and procalcitonin as biomarkers for a novel neonatal sepsis diagnostic platform (ASCMicroPlat)

Abstract

Background: Neonatal sepsis contributes significantly to morbidity and mortality and encompasses a multisystemic inflammatory response to a microorganism. A lack of suitable diagnostic biomarkers and delays in microbe identification (48 to 72 hours) challenge clinical decision-making. C-reactive protein (CRP) is the current biomarker for sepsis in patients; however, use of earlier markers such as procalcitonin (PCT) could prove more effective. This study aims to assess the clinical utility of combining CRP and PCT for a novel sepsis diagnostic biomarker platform (ASCMicroPlat). Methods: Blood samples were obtained from 350 infants evaluated for sepsis at the Coombe Women and Infants University Hospital. Eligible infants met one or more inclusion criteria: age =5 mg/l) CRP tests occurred in 69% of LCBSI. PCT quantified samples to date (n=100) ranged from 0.03 to 67.23 ng/ml. Both analytes featured in higher cases that suggested sepsis than positive blood culture numbers: 56 out of 350 cases had CRP levels >=5 mg/l, for PCT 23 out of 100 individuals tested positive at the cutoff (>0.5 ng/ml) for bacterial infection. Conclusion: Sepsis diagnosis requires accurate detection biomarkers; preliminary study findings show that CRP is present in the majority of bloodstream infections. Furthermore, results using both biomarkers suggest that blood culture results do not indicate all cases of true sepsis. Further research will correlate the completed CRP and PCT gold-standard dataset with that produced by ASCMicroPlat PCR-based assays to assess the clinical utility of this device for sepsis diagnostics.