Considerations on the development of quantitative lateral flow tests (qLFAs)

The presentation “Considerations on the Development of Quantitative Lateral Flow Tests (qLFAs)” by Dr. Klaus Hochleitner (Cytiva) outlines the principles and challenges of designing qLFAs, which differ from qualitative tests by enabling precise analyte concentration measurement. It explains assay types (sandwich vs. competitive), key performance parameters (LOD, LLOQ, ULOQ), and sources of variability such as sample composition, membrane properties, reagent quality, and manufacturing processes. The document emphasizes minimizing measurement uncertainty through rigorous material selection, controlled processes (conjugation, lamination, dispensing, drying), and robust quality control. It also reviews result interpretation options, including electronic readers, customized systems, and mobile apps, concluding that quantitative tests demand greater development effort, validation, and supplier collaboration than qualitative assays.