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Unyvero Solution
Caution - Investigational device, limited by federal (or United States) law to investigational use. Products and documentation are not available to customers within the United States.
Fast, reliable infectious disease testing
The Unyvero Solution targets severe bacterial infections as first disease area. Almost full automation with minimal hands-on time is achieved by integrating all test processes with results available in approximately 3 hours.
High performance DNA yield
Curetis universal sample preparation technology (patent pending) prepares DNA from many native sample within a few minutes - without losing time for pre-culturing the sample. Curetis technology e.g. efficiently extracts DNA from different microorganisms (Gram-positive and Gram-negative bacteria, viruses and fungi, mycobacteria and other intracellular organisms) even in complex samples like in highly viscous sputa or in samples with poor quality or contaminated with blood.
Cutting edge in molecular detection of antibiotic resistance
The early detection of antibiotic resistances is key to improve clinical outcome. Curetis technology uniquely addresses the analysis of antibiotic resistances simultaneously to bacteria detection.
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Antibiotic resistance is based on different complex mechanisms involving genes for replication, transcription and translation as well as in the energy metabolism. Often a resistance is not encoded by a single gene and involves multiple mutations. The Curetis team has gathered extensive knowledge in molecular antibiotic resistance mechanisms over the past years. Curetis expertise allows comprehensive antibiotic resistance testing for a wide range of antimicrobials in approximately 3 hours.
Truly overcoming current limitations in infectious disease testing
While culture-based diagnostics are often too slow, conventional molecular testing is too cumbersome. Unfortunately, none of the diagnostic tools available today provides the fast and comprehensive clinical information needed to make informed treatment decisions. Curetis technology may help to close this gap.
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Culture-based diagnostics
Microbial culture is the current standard for the diagnosis of bacterial infections. Typically it needs at least 2 to 5 days to provide diagnostic information. This is too slow, resulting in empiric treatment decisions, which, in turn, have been shown to lead to a high rate (~40%) of initially inadequate antibiotic treatments associated with a higher mortality. A recent clinical study shows that each hour of delay in administering an effective antimicrobial therapy results in an average 8% decrease in survival.
Conventional molecular diagnostic testing
Overcoming some limits of culture-based methods, currently available molecular methods identify some pathogens and a few drug resistances. However, most molecular testing is too complex: the predominantly manual work flow is time consuming and testing typically requires special infrastructure as well as skilled operators. As today's health systems are confronted with high cost pressure and a lack of personnel, molecular infectious disease testing often is not applied.
The Unyvero solution is designed to meet customer needs
The Unyvero Solution
- detects broad panels of bacteria and antibiotic resistances from a single sample in one run covering all clinically relevant bacterias and their antibiotic resistances causing a certain disease
- enables testing of many clinically relevant native samples
- seamless integration into the cycle of care at any location with a modular concept
- provides high productivity through
- minimizing operator time to a few minutes with full walk-away automation based on a simple and consistent work flow for any clinical application
- low implementation requirements and low total cost of ownership, as no staff with molecular biology skills nor special infrastructure is needed
- configurations that meet individual customer needs, satisfying through-put demands ranging from a few up to several hundreds of tests per day
- optimizing the routine hospital work flow by a sophisticated information management
- enabling point of need testing even in resource limited environments
- delivers clinically relevant information within 3 hours, to aid an informed therapy decision as early as possible.
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The Unyvero Solution is based on hardware components including device-specific software and a disposable cartridge. It is a qualitative nucleic acid multiplex test system intended for the simultaneous detection and identification of nucleic acids associated with a range of bacteria and antibiotic resistances.
The Unyvero Solution features a 'sample to result' approach and consists of
- the Unyvero L4 Lysator for pathogen lysis
- the application specific Unyvero Cartridge analyzing a broad range of disease specific analytes
- the Unyvero A50 Analyzer handling the cartridge
- the Unyvero C8 Cockpit for intuitive user interaction and control
- and the optional Unyvero Server Software for integration into the hospital's LIMS / HIS environment.
Curetis infectious disease testing - Four simple interactions
A simplified work flow with a minimum of user interaction ensures the most efficient use of resources and should contribute to the reliability of the results.
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The intuitive simple work flow is consistent across all clinical applications and sample types, thus drastically reducing invalid test results due to operator errors:
Step 1: transfer the patient sample into the Unyvero Sample Tube preloaded with reagents
Step 2: place the Unyvero Sample Tube into the Unyvero Lysator
Step 3: insert the Unyvero Tube and the Unyvero Master Mix into the Unyvero Cartridge and scan the cartridge with the bar code reader.
Step 4: load the Unyvero Cartridge into the Unyvero Analyzer for further fully automated processing.
The comprehensive results are available in approximately 3 hours and will be displayed on the Unyvero Cockpit without any further operator interaction. Different built-in quality control measures allow checking for the validity of results throughout the whole measurement.
© Curetis AG 2012