Abstract

Clinical Validation of a Microfluidic Point-of-care Diagnostic System for Neonatal Sepsis - ASCMicroPlat

Katherine McAllister, Research Scientist, Queens University Belfast

The clinical validation phase of the EU project ‘ASCMicroPlat’ performance tested a microfluidic PCR diagnostic system for fast detection of neonatal sepsis pathogens in 4-hours.Serum was obtained from the bloods of 500 newborn infants evaluated for sepsis at the CWIUH. Eligible infants met one or more inclusion criteria: age =6 weeks, clinical sepsis signs, and/or maternal sepsis risk factors. 200µL serum from either uninfected or infected neonates was mixed with magnetic beads and loaded onto a labdisk for integrated DNA extraction, pre-amplification, and real-time PCR detection of a bacterial panel. Clinical testing demonstrated the capability of the system to detect a range of pathogens including Escherichia coli, Klebsiella oxytoca, Klebsiella pneumonia, Staphylococcus capitis, Staphylococcus epidermidis. Timing is crucial in sepsis diagnostics, every hour that passes during the sepsis syndrome increases the likelihood of patient mortality. The ASCMicroPlat system offers a fast POC test for sepsis, and potentially better patient treatment and survival.