The user only transfers the patient sample into the Unyvero Tube pre-filled with specific reagents and lyses it in the Unyvero Lysator. The Unyvero Lysator even handles complex samples like viscous sputa, thus ensuring high DNA yield after extraction. It accepts a wide range of sample types because of a proprietary sample processing method (patent pending) including sputum, bronchoalveolar lavage (BAL) and protected brush specimen.

The Unyvero Cartridge integrates all sample analysis steps to execute a complete test: DNA purification, PCR set-up, multiplex end-point PCR and amplicon detection by hybridization to oligo probes spotted on membrane arrays. Therefore the closed Unyvero Cartridge is amongst other parts equipped with integrated reagent containers, a DNA purification column, PCR chambers and an according number of arrays. The cartridge is pre-filled with buffers for DNA clean up, reagents and fluorescence-labelled primers for PCR amplification, respectively for array hybridization of the PCR product.

After sample lysis, the user assembles the cartridge by simply inserting the Unyvero Tube with the lysed sample and the Unyvero Master Mix Tube - no further hands-on steps are necessary. Once assembled, the cartridge is a physically closed system – avoiding any possibility of spilling sample fluids or reagents, and minimizing contamination risks. The disposable cartridge is compatible with standard waste disposal procedures of hospitals and laboratories.

For quality management purposes an internal control (a synthetic gene, without any homology to known sequences) is processed on the cartridge together with the patient sample. This approach enables the control of the entire work flow from lysis, DNA purification and amplification to detection.

The Unyvero Analyzer automates all processes in the cartridge including genomic DNA purification, multiplex nucleic acid amplification with end-point PCR and the detection of the target sequences after hybridization on a special array. The Unyvero Analyzer consists of mechanical, electronic and optical elements to control all sample processing and analysis steps, which happen inside the sealed cartridge.

Each Unyvero Analyzer has two cartridge slots that allow to process two Unyvero Cartridges completely independently (random-access). Multiple Unyvero Analyzers can be stacked or placed side-by-side to increase system throughput capacity as needed. For safety reasons, the Unyvero Analyzer does not contain any reagent or waste – all reagents and waste are contained in the disposable Unyvero Cartridge and will be disposed together with the used cartridge.

The Unyvero C8 Cockpit provides a touch screen controlled user interface guiding the user through the entire work flow step by step. The Unyvero C8 Cockpit can handle and control up to two Unyvero Lysators and up to eight Unyvero Analyzers. An integrated bar-code reader enables quick patient information entry and also tracking of the entire work process. The software manages automatic result generation and storage and supports users with detection of lot numbers and expiry dates check. Each test can be started with a simple finger tip and results are automatically processed and displayed without requiring any further interaction.

Curetis Server Software features centralized management of distributed Unyvero systems and the connectivity to third-party systems, like hospital servers.