connectivity by design.
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During the pandemic, there was an urgent need for large-scale reliable Covid-19 testing on the spot, for example, at airports or entrance gates to crowded events. Our customer, miDiagnostics, immediately decided to create a portable, ultra-fast PCR Covid-19 test system. In less than a year, we developed the associated ‘reader’, a device for thermocycling and reading out disposable assay test cards. We also supported the development of these test cards.
The heart of miDiagnostics’ Covid-19 test solution is a microfluidic chip integrated in a 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 the optical detection system based on fluorescence. This involved selecting an appropriate light source and suitable optical filters as well as a reliable detector.
We devised the industrial design of the reader to suit its specific application, giving it a robust and appealing, 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. Traceability of test results is ensured by scanning the barcode engraved in each test card; for this, we integrated a barcode scanner in the design. To conclude, we provided the required documentation to miDiagnostics for their efficient, successful CE-IVD certification procedure.
It really was a multi-stakeholder project, with teams from various partners contributing. Our development team engaged in an intensive collaboration with customer teams working on the assay and on disposable development, and with a team of the contract manufacturer selected for the production of the reader. For example, designing the reader 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 functional device within the tight schedule. This project may well have launched the creation of a generic reader for all kinds of PCR tests, contributing to the current shift of medical diagnostics from the lab to the point-of-care.