Abstract

Practices and Challenges During Assay Optimization and the Transition Process to Manufacturing For Lateral Flow Assay Device Development

Debra English, Manager Biochemistry Applications, GVS North America

Lateral flow assays are deceptively simple, rapid, inexpensive diagnostic tests which are used in clinics as well as remote areas.  However, the iterative process to develop and optimize a “simple”, robust, easy-to-run, sensitive assay reveals the complexity of a LFA.  A lateral flow assay consists of 3 key categories:  (1) biological reagents and buffers, (2) pads/membranes to store, transport, capture or detect such reagents, and (3) the assembly of all components into one working device.  The use of an antibody pairing matrix, progressing from half stick to three quarter to a full stick format and transitioning as soon as possible from spiked buffer to real sample are practices used during assay optimization.  Further optimization occurs during the transition from lab bench to manufacturing scale.  Some real-life examples of optimization will be discussed during the talk.