Abstract

Implementation of a Neonatal Sepsis Study for Clinical Assessment of a Point-of-Care Diagnostic Tool - ASCMicroPlat.

Katherine McAllister, Research Scientist, Queens University Belfast

Sepsis is one of the leading causes of infant death worldwide and there is market need for a fast diagnostic system. The management of patient sepsis is challenged by short-comings in current diagnostics. The gold standard for microbe-identification using blood culture takes 2-3 days; furthermore biomarkers that identify abnormal sepsis cascades are limited to C-reactive protein (CRP). This abstract describes the clinical component of the EU project: Fast Automated Multiplex Analysis of Neonatal Sepsis Markers on a Centrifugal Microfluidic Platform (ASCMicroPlat). ‘ASCMicroPlat’ aims to detect neonatal sepsis using an integrated microfluidic PCR assay approach for a microbial and biomarker panel in 1-2 hours. Bloods from 430 infants (mean-age+/-SD: 3.1±11.4 days) evaluated for sepsis at the CWIUH were subject to gold standard blood culture and CRP and procalcitonin (PCT) immunoassays. The most prevalent organisms cultured from babies with laboratory-confirmed bloodstream-infections were Escherichia coli (35%) and Streptococcus agalactiae (Group B strep) (22%). These are amongst the organisms included in the RTPCR panel. CRP levels ranged from =0.1-226mg/L while PCT rarely exceeded 100ng/mL; ranges accounted for during immuno-PCR assay design. Future work will correlate the patient gold-standard dataset with that produced by ASCMicroPlat to assess clinical utility of the device for sepsis diagnostics.