A molecular test for sepsis
Sepsis is a life-threatening complication of an infection and has a very high mortality rate of up to 50 %. Nearly 10 % of all admissions to the intensive care are due to sepsis and the numbers are rising. Current diagnostic procedures entail microbiological culture and can take up to 48 hours to provide an answer. However, given the urgency of the condition, faster results are needed. Molecular diagnostics have the capacity for pathogen identification and detection of antibiotic resistance in a couple of hours. The EU-funded SPCARD (Development of a fully automated, integrated solution that can support a wide range of complex sample preparation protocols) study set out to bring molecular diagnostics to the point of care. The primary objective was to develop an instrument that can perform automated pathogen DNA enrichment from large volumes of blood. The consortium designed the instrument to contain a liquid sensing element that can detect an array of different bacteria and fungi at very low concentrations (1-10 CFU/ml). The disposable cartridge was built to withstand sterilisation conditions and incorporated a simple interface for plugging in a blood tube. The device processes the sample for 30 minutes, which is then sent for standard molecular analysis. This includes techniques such as DNA extraction and amplification of bacterial sequences. Prior to commercialisation, researchers validated the instrument prototype using real clinical samples. This gave them the opportunity to align their molecular analysis results with standard culturing results as well as medical data. Taken together, the SPCARD project generated an automated, integrated solution for the molecular diagnosis of sepsis at the point of care. Contrary to the gold standard of sepsis diagnostics, this rapid test is expected to revolutionise disease treatment and outcome.
Keywords
Sepsis, molecular diagnostics, point of care, cartridge, DNA
