A-349 Septec: A Microfluidic Platform for the Rapid Diagnosis of Bloodstream Infection Diagnosis and Associated Sepsis Management

Abstract Background Sepsis is a life-threatening disorder resulting from a dysregulated host response to infection. Globally, sepsis is responsible for 11 million deaths annually and is associated with high mortality and morbidity. Sepsis can arise from any infection by microbes or viruses; however, the most common cause is bloodstream infection (BSI) via bacterial pathogens. Rapid identification of organisms responsible for BSI may reduce time until the administration of suitable antibiotics and employment of rapid diagnostics at patient bedside further strengthens their value as informed clinical decisions can be made and acted upon within shorter timeframes, potentially enhancing patient outcomes and preventing progression to more critical sepsis or septic shock. This study reports on the analytical and clinical performance of the SepTec microfluidic assay, an in-vitro diagnostic device capable of rapid detection of bloodborne pathogens of gram-positive, gram-negative and fungal origin from whole blood within 15 minutes. Methods Analytical performance of the SepTec assay was studied as follows: limit of detection (LoD), reproducibility and impact of interfering substances. Sterile and infected blood samples were obtained either through the generation of contrived samples or through clinical collaboration. Clinical performance was determined retrospectively and prospectively on a total of 146 patients. For both the retrospective and prospective clinical studies, results were compared against blood culture. Results The LoD of the SepTec assay for S. Aureus, E. coli and C. albicans from contrived blood samples was 10 CFU/mL for each pathogen. CVs were calculated at 4% for organism detection in whole blood samples. From retrospective and prospective analysis, the SepTec assay showed 100% sensitivity and >96% specificity. Conclusion The SepTec assay can detect microbes from blood and differentiate between gram-positive, gram-negative or fungal pathogens with high sensitivity and specificity. Turnaround time for the test is estimated at 15minutes, rendering it with the potential to be a significantly more rapid approach than the gold-standard blood culture, or many molecular approaches. It is hoped that this work with yield a point-of-care diagnostic platform which will enhance sepsis management, overall improving patient outcomes.