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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.

Antibody selection is one of the most influential decisions made during early Lateral Flow Assay (LFA) development. Whether antibodies are sourced commercially or developed as part of a broader LFA development service, the choices made at this stage directly affect assay sensitivity, specificity, reproducibility and long-term manufacturability. Applying a structured, risk based approach to antibody evaluation can significantly reduce technical and commercial challenges later