Lateral flow test prototyping, FHNW School of Life Sciences

Lateral flow assays (LFAs) are rapid immunochromatographic tests that detect a target analyte in a small, unprocessed sample within minutes, without instrumentation. Once associated mainly with pregnancy and infectious disease testing, they are now broadly used for applications including screening drugs-of-abuse, cardiac markers, veterinary diagnostics, food safety and agricultural and environmental monitoring.

Within our specialised laboratory, we collaborate with partners to develop, optimize and manufacture lateral flow tests across a broad range of biomarkers. Our team holds particular expertise in the detection of analytes at low concentration, the analysis of complex sample matrices, and the development of multiplexed assays capable of measuring several biomarkers on a single strip.

Our facility runs on industry-standard BioDot dispensing and processing equipment, for easy transfer to commercial manufacturing. Our semi-automatic assembly line can produce up to 1000 test cartridges per week to support early-phase clinical studies.

• Feasibility and assay design: assessing the biomarker and the target performance, sourcing and screening antibody pairs and membrane/pad materials, building a first functional prototype.
• Assay development and optimisation: tuning sensitivity, specificity and reproducibility, reducing non-specific binding and cross-reactivity, and validating the limit of detection, including for challenging low-concentration and multiplexed targets.
• Assembly: antibody striping, lamination and cutting of the strip (sample pad, conjugate pad, membrane, wick) and housing into cartridges on our semi-automatic line, up to 1000 per week for early-phase clinical studies.
• Reader integration: configuring qualitative, semi-quantitative and quantitative readout on standard or partner supplied custom LFA readers.