Abstract

Shortening Development Time and Improving Performance of Rapid Diagnostic Tests

Bernhard Weigl, Director, Center for In-Vitro Diagnostics, Intellectual Ventures/Global Good

Lateral flow and similar rapid diagnostic assays (LFAs) are easy to use and manufacture, low cost, rapid, require little or no equipment to operate, and do not need to be refrigerated. However, they are generally not considered to be very sensitive or able to provide a quantitative result. This lack of sensitivity is not a fundamental property of LFAs but rather a consequence of the way they are developed, manufactured, and marketed. Historically, most lateral flow tests were developed and optimized by relatively small manufacturers with limited R&D capabilities and budgets, and were generally used only for analytical targets prevalent at high concentration in patient’s samples that were relatively easy to measure.In contrast, our group’s mission is to develop LFA-based assays for use in global health applications that are as sensitive as the best conventional diagnostic assays (in some cases even better) while retaining all their cost, simplicity, and usability advantages. We have developed a 3D modeling platform for paper-based assays and are using it to determine the theoretical limit of a particular assay variant, as well as a rapid array-based empirical optimization system for lateral flow assays. Together, these approaches allow the development of more sensitive assays with shortened development time. In this presentation we will describe the assay optimization methods we employ, as well as several assays under development, including ones for malaria, and TB.