Curetis AG announced positive clinical data from an independent study conducted by researchers from the Department of Medical Microbiology of Maastricht University Medical Center (MUMC). Curetis representatives say the findings demonstrate the high clinical sensitivity of the Unyvero P50 Pneumonia application in detecting pathogens, including samples with low pathogen concentrations. The researchers compared the performance of the Unyvero P50 cartridge with conventional microbiology culture in broncho-alveolar lavage fluid samples for the diagnosis of ventilator-associated pneumonia (VAP), a common complication in intensive care patients.
Using the quantitative culture standard, Unyvero P50 Pneumonia correctly detected eight different important pathogens in all VAP samples (n=44) at 100% sensitivity. The overall sensitivity of the Unyvero P50 panel was 88.6% at clinically relevant pathogen concentration. Unyvero P50 was also able to detect eight different clinically relevant pathogens in 12 patient samples where conventional microbiology culture failed. This data confirms previous results where Unyvero had consistently detected pathogens missed by conventional culture.
“Our Unyvero application exhibited exceptional sensitivity, even at low concentrations. Importantly, P50 was able to detect pathogens in 12 samples where conventional microbiology failed,” says Gerd Luedke, PhD, Director Bio-Assay Development for Curetis. “Within four hours, our application identified close to 90% of all pathogens within the specified cutoff and even 60% with concentrations below this threshold.”
The Unyvero technology is for investigative purposes only and is not currently available for sale in the United States. Curetis is running a prospective multi-center clinical trial aimed at achieving FDA clearance. Learn more about the Unyvero Cartridge Technology.
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