The objective is to develop a centrifugal microfluidic system for fully automated and parallelized allergy testing of 10 blood samples against to 10 BLCs in 30 min. The final design will be based on the bioassay protocol (T2.4 and T3.5), manufacturing specifications and performances of the drive platform (T1.1). Provisionally, the following microfluidic unit operations will be integrated: plasma separation from whole blood samples, plasma metering, controlled transport of sample and reagents, mixing of sample with micro-particles for pre-concentration of IgEs and to assist the detection, as well as incubation and detection steps. During this WP the microfluidic system is to be industrialized, with a clear focus on quality and cost.
The following specific objectives will be covered:
1. Development of microfluidic concept and design which meet the specifications of the assay, manufacturing requirements for compact discs and disc drive;
2. Fabrication of disc prototypes ultimately containing the microfluidic structures with integrated detection zones for sensitive detection of 10 BLCs per sample, pre-concentration system (by a factor of approx. 500-1000), and sample preparation system (separation of plasma and sample purification with the final chemical composition according to the clinical standards). Note that WP2 will include prototyping for proof-of-concept and optimization of the fluidic design, as well as fabrication of integrated discs by industrial methods.
3. Testing of the disc prototypes on the centrifugal test platform using water-based solutions as well as blood samples, developing a centrifugation protocol for integrated assay on a disc. All assay steps are integrated on a disc to process samples of 100 – 300 µL, complete centrifugation protocol within 20-25 min, and sample purification, preserving the IgE activity;
4. Industrialization of all manufacturing processes: fabrication of the master: final microfluidic design fabrication; and disc prototyping;
5. Fabrication Quality Control: non-destructive optical in-line QC and end-point QC;
6. Cost-Effective Manufacturing: less than 1€/disc in mass production scale. To ensure future commercial exploitation of the developed technology, the Directive 98/79/EC’ In Vitro Diagnostic Medical Devices’ requirements will be considered right from the start of WP2.