swift development of ultra-fast PCR Covid-19 system.
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During the pandemic, there was an urgent need for large-scale, reliable, on-the-spot Covid-19 testing, at airports or entrance gates to crowded events, for example. To provide this, miDiagnostics immediately decided to create a point-of-care, ultra-fast PCR Covid-19 test system. In close collaboration with miDiagnostics, we developed an ultra-fast PCR system within one year. We supplied the instrument and supported the assay and disposable development.
thermal and optical design.
The miDiagnostics’ Covid-19 test solution can provide test results within 12 minutes. At the heart is a microfluidic chip integrated in the test card. Here, the polymerase chain reaction (PCR) can take place driven by thermocycling. For the required ultra-fast temperature profiles, we developed a customized thermal actuator and an advanced control system. We also designed a 4-channel fluorescence system for the optical detection. This involved selecting an appropriate light source and suitable optical filters as well as a reliable detector.
suitability, usability, certifiability.
We devised the industrial design of the reader to suit its specific application, giving it a robust, appealing and trustworthy medical appearance. The housing was made light-tight to prevent ambient light from interfering with the fluorescence detection. The device is easy to use, with only one LED status indicator. It interfaces with a central computer that processes the data and presents the results to the user. Multiple readers can be connected, allowing parallel testing. To conclude, we provided the required documentation to miDiagnostics for their efficient, successful CE-IVD certification procedure.
"we developed the reader from idea to certified device within a tight schedule."
It really was a multi-stakeholder project, with contributions from teams of various partners. Our development team engaged in an intensive collaboration with assay and disposable development teams. The selected contract manufacturer provided valuable input, ensuring manufacturability early in the project. Reader development had to take place in parallel with test-card development, requiring intensive interaction between the teams involved. I’m proud that we managed to bring the reader from concept to a certified system within the tight schedule.