ChromaZona is an IVD certified instrument for automated antibiotic susceptibility testing and microbial ID, designed for speeding up testing in the clinical laboratory.
Working to EUCAST and CLSI guidelines, the system's sensitive CCD camera, unique three channel lighting and powerful Chromogenic ID software, microbial species on chromogenic plates can be identified in seconds. Then by accurately analysing zones around antibiotic discs and MIC strips using ChromaZona's eAST software, appropriate antibiotics to treat the infection can be determined.
ChromaZona can be easily connected to a LIMS system or, if preferred, reports can be generated and stored in Excel, eliminating data transfer errors as well as providing the user with fully traceable information and reports. The stored results can be analysed at any time and used to identify and monitor incidence of bacterial resistance, helping to improve infection control.
ChromaZona is suitable for use in a CFR Part 11 environment.
ChromaZona comes complete with eAST and Chromogenic ID software.
The eAST (easy Antibiotic Susceptibility Testing) software accurately measures zones around antibiotic sensitivity discs and with one click, results can be automatically compared to data from all the tested organisms that have minimum inhibitory concentration (MIC) breakpoint values in the EUCAST and CLSI databases. The software will then list in seconds which antibiotics the microbial pathogens being tested are sensitive to, saving hours with manual analysis and cross referencing of expert rules.
eAST software offers:
The Chromogenic ID software is a unique colour recognition software designed to make identification of colonies on chromogenic agar accuate, objective and simple. A wide range of microbes can be cultured on media from suppliers including CHROMagar, E&O, ThermoFisher and Hardy Diagnostics and can be automatically identified. Organisms are quickly identified at the touch of a button and data and images stored as a permanent electronic record.
Chromogenic ID software offers:
More and more laboratories require IQ/OQ/PQ verification these days. Synbiosis's IQ/OQ/PQ procedures take the user through each step in the verification of a Synbiosis system in meeting the demands of the laboratory, regulatory compliances and standard operational procedures (SOP). These simple procedures allow the user to verify that a system meets defined installation, quality and performance specifications.
Installation Qualification (IQ)
This verifies that when a system is unpacked it conforms with all purchasing, shipping and unpacking documents. Once this procedure has been followed the system is then ready for the operational check process.
Operational Qualification (OQ)
This procedure establishes if the system meets all the operation and functionality specifications. An operational test is also included at this stage.
Performance Qualification (PQ)
A performance check will establish if the system meets the specification for the nature of the purpose it was intended for. This is verified by using a simple target to establish if the system can meet performance criteria.
Each set of IQ/OQ/PQ documents contains a complete set of procedures and checklists for following the verification steps. Included with each ‘pack’ is a simple calibration device (target image) so that the performance of the system can be checked against the PQ requirements. Each set of documents is unique to a particular system and has to be ordered with the system itself. The document pack has full instructions for use and implementation.
Who does this?
Customer - typically a customer can perform these tests by themselves. Their own internal QC department will be familiar with these processes.
Synbiosis or its distributors
Trained Synbiosis personnel or trained distributors can also perform the IQ/OQ/PQ procedures, normally at a nominal charge.
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