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An open microfluidic point-of-care diagnostic (POC) platform will be presented that not only combines the ability to carry out various kinds of immunological, molecular or clinical chemistry tests at the point-of-care, allows for different sample types and can be used with a variety of detection technologies but in particular serves as open platform for users to integrate their own assays. The key advantages are as follows: 1) A standardized microfluidic cartridge architecture, with a common footprint, defined areas for functions allows for a toolbox-like development of a whole family of cartridges all using the same manufacturing tool and validated modules. 2) This finds its correspondence in the instrument which runs the cartridges. Standard footprint and common locations for functional elements makes the instrument versatile and able to run a variety of different assays in one instrument or allows for a rapid adaptation to new assays. 3) From an assay developer standpoint, such platforms with a proven system architecture provide a convenient pathway towards a simplified regulatory approval.
On the presented platform, we have implemented a variety of assays, molecular diagnostics assays for infectious diseases. In case of these assays, the preferred detection method uses fluorescence. For immunoassays, colorimetric measurements with a simpler camera system are possible. In addition, the system also allows for the integration of sensors for detection.
All cartridges include the complete assay flow from sample introduction to read-out. This includes all sample-preparation steps such as sample homogenization, sample lysis and nucleic acid extraction and concentration. In addition, all reagents required are embedded in the cartridge, either in liquid form or as dried reagents in dedicated locations.
Overall, this platform allows especially small and medium-sized diagnostic companies and initiatives a rapid transition from bench to the market at a reasonable cost, significantly less compared to an ab-initio development.
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