A universal platform for nucleic acid based point-of-care diagnostics

At the point of care there is an unmet need for fast, flexible, and userfriendly diagnostic tools for the specific recognition of pathogens. We developed a novel platform based on polymerase chain reaction (PCR) combining microfluidic integration and a fully automized processing unit offering an overall processing time below 45 minutes. All microfluidic elements are combined into a disposable centrifugal disk which can have all reagents prestored. The disk has a high degree of multiplexing and can, in principle, be equipped with any PCR assay. The centrifugal microfluidic design allows the entire reaction to occur in the purely passive disk. Consequently, all active components, particularly the rotation unit, the heating unit, and the fluorescence readout module are integrated into a fully automated ""sample-to-answer"" point-of-care device. In this contribution, we present the functional units of the platform as well as their interaction. Special emphasis is given on the fast thermocycling based on a non-equilibrium approach with direct infrared liquid heating. The platform has been tested with pathogens related to sexually transmitted infections and respiratory diseases. The quantitative results compare well with commercial systems. Research leading to these results has been funded by the German Federal Ministry of Education and Research (BMBF) under grant number 16SV5406, ""UNISOND"".