How IVD Assays Impact Microfluidic Chip Design

Microfluidic chips function as a system of interconnected components and one of those components is the assay itself. Before the device is fabricated, the assay requirements must be evaluated and understood. Device developers must answer many questions about the assay:

• How do we get the target analyte to be detected and/or measured?

• What preanalytical processing must be done prior to the actual assay?

• Can the processing be done on the device, or must it be done by the user prior to the sample being introduced into the device?

• What is the volume and composition of the sample matrix and reagents?

• What user skills are required to handle the test from sample collection to cartridge loading?

• What potential sources of bacteria or virus could be in the sample matrix or the analyte to be detected and/or measured?