Optimization and bundling of diagnostic resources: Increased sample throughput in diagnostic laboratories, mobile laboratory diagnostics and on-site point-of-care testing
The SARS-CoV-2 pandemic is associated with significant consequences that extend to large segments of society. Preventive measures such as the regulation of public behavior and events, as well as isolations up to and including lockdowns, are being used to contain the outbreak. While this is considered necessary to control infection transmission, at the same time the economic, educational and mental health impacts are devastating. Therefore, to balance individual freedom and protection from COVID-19, comprehensive capabilities for rapid identification of infected individuals are particularly needed.
The goal of CoV-2-KomET is to enable a comprehensive, specific, sensitive and rapid identification of infected individuals by optimizing and bundling test methods and options available in diagnostics, and to complement central laboratory diagnostics with mobile, miniaturized and precise test systems. For this purpose, a method will be developed, validated and tested on clinical samples that is capable of increasing sample throughput in diagnostic laboratories by at least one order of magnitude compared to the standard method, in order to realize the next step towards a cost-effective comprehensive testing. Furthermore, simple, innovative, efficient, sensitive and scalable technologies and methods for use in on-site rapid diagnostics will be developed. For this purpose, miniaturization and full automation of the analysis process, as well as minimal complexity, scalability, cost efficiency and highest sensitivity for the required short test duration is the focus of the project. Together, this should enable widespread use at the point-of-care and allow a differential diagnostics. In a mobile and flexible platform as a »rolling laboratory«, the use of an early detection and prevention of SARS-CoV-2 infections will be demonstrated. In this context, the project is an addition to the CoVMoTe project, which is also funded by the Fraunhofer Society.
At Fraunhofer IZI-BB, innovative molecular biological detection strategies are being developed, tested and optimized for this project. The methods used exhibit a sensitivity comparable to that of qRT-PCR used in central laboratories, with significantly reduced complexity and (time) requirements. A multiplex approach allows the precise detection of the virus and allows a differential diagnosis. In a cooperative approach, the process duration of sample processing for SARS-CoV2 diagnostics as well as the manual process steps required will be further adapted and improved for the on-site application. The optimized detection methods will subsequently be integrated into a microfluidic disposable cartridge with optical sensors, thus enabling a rapid, simple and cost-effective testing.