Multiplex Diagnostic System Development

Building a diagnostic solution requires developing the biochemical assay, microfluidic cartridge, instrument, software and a reproducible manufacturing process at the same time. LABADVANCE develops the instrument–cartridge platform as a single product — from the specification and lab assay scheme to a functional prototype and documentation package for the next project stage.

The platform is not limited to a fixed test menu: the cartridge and analyzer are designed around the chosen biomarkers, sample matrix and detection method. The cartridge integrates sample preparation — metering, plasma separation, filtration, lysis, extraction, mixing, incubation and waste collection — for whole blood, plasma, serum, saliva, urine, swabs and other biological fluids. A multiplex analytical zone detects nucleic acids, proteins, antibodies, metabolites and other markers simultaneously, with internal controls.

Microfluidics, thermal control (including PCR cycling and isothermal amplification), optics, electronics and software are developed by one team in a single architecture. Fluorescent, colorimetric, absorbance and electrochemical detection are possible; the software runs the assay cycle, checks controls and generates the result. Assembly, reagent storage, quality control and the transition to production polymer cartridges are considered from the earliest stage.

Deliverables can include functional cartridge and analyzer prototypes, schematics, design documentation, software, test protocols and DFM recommendations. The lab prototype is not a registered medical device: analytical and clinical validation, series production and registration are carried out as separate stages.