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Performance verification is the stage at which a lateral flow assay moves from development understanding to formal analytical evidence. This article explains how intended use and design inputs shape verification strategy, how CLSI-guided studies are structured, and why robust documentation is critical for transfer, submission, and product readiness.

Preparing a lateral flow assay for transfer means moving from a feasible prototype to a process that can be controlled, reproduced, and sustained in manufacture. This article explores what transfer readiness really means, how robustness studies, pilot batches, documentation, training, and validation fit together, and how to establish a process that can support routine production.

Just as careful antibody selection is critical for Lateral Flow Assay (LFA) performance, the choice of detector label and its conjugation strategy directly influences assay sensitivity, specificity, reproducibility and scalability. Detector labels convert binding events into measurable signals and the way these labels are prepared and evaluated has a profound impact on how reliably an assay performs. Gold nanoparticles have become the most widely used detector because of thei