Curetis makes Unyvero i60 Implant and Tissue Infection cartridge available in Europe

May 12, 2014

Curetis AG, a developer of next-level molecular diagnostic solutions, has launched its new Unyvero i60 Implant and Tissue Infection (ITI) cartridge in Europe. The new cartridge for the Unyvero system was developed to rapidly identify more than 90 pathogens and more than 20 resistance markers common in eight clinical indications. Commercial launch and roll-out has already begun in close collaboration with Heraeus Medical GmbH, the development and commercialization partner for the Unyvero i60 cartridge. The company has made first placements at major clinical centers in Germany, Austria, and Switzerland.

The i60 cartridge has been CE-IVD marked following the successful completion of a CE performance evaluation study involving more than 750 cartridges. Analytical sensitivity testing was conducted in 350 cartridges, while more than 400 cartridges were run with patient samples. Samples of various clinical indications were obtained for the trial, including periprosthetic joint infections, diabetic foot, catheters, surgical sites, skin and soft tissue, and cardiology-related infections.

The Unyvero system analyzed native clinical sample types such as swabs, synovial fluid, sonication fluid, tissue, and catheters. Among others, the i60 cartridge detected several key pathogens with sensitivities in the range between 75% to 100% at an overall panel sensitivity of 67% and panel specificity of 97.8% for the 81 analytes that have been successfully validated so far. According to company spokespersons, the i60 cartridge also identified 147 clinically important pathogens not found by standard microbiology culture. In particular, in every second sonication fluid and every third synovial fluid sample, i60 detected pathogens missed by microbiology culture. Pathogens most often overlooked by culture but identified by i60 were Enterococcus sp., Finegoldia magna, Corynebacterium sp., Enterobacter cloacae, and Acinetobacter baumannii. Resolution of these discrepant results is ongoing. Learn more about Unyvero Cartridge technology.

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