D.A. Kidwell, K. Le
Naval Research Laboratory,
United States
Keywords: POC assays, fuel cell, electronic
Summary:
Lateral-Flow Immunoassays (LFIAs) are nearly ideal point-of-care technology. They are portable, rapid, self-contained, inexpensive to manufacture, can detect diverse species and diseases, and require no power to operate. They are widely used as pregnancy, HIV, or influenza tests, and most recently for detection of COVID-19. However, typical LFIAs are not quantitative nor are they sufficiently sensitive to diagnose a disease in the early stages. We have developed a form of LFIAs that can be electronically read with inexpensive and portable readers the size of home glucometers. This system leverages our proven methodology of using catalytic nanoparticle labels with LFIA technology[1] yielding a 500-fold improvement in sensitivity over commercial LFIAs using gold nanoparticles. Our electronic readable system is known as fcLFIA™ or the fuel cell Lateral Flow ImmunoAssay and adopts the principles of fuel cells to provide signal transduction. [2] The catalytic nanoparticle labels used as the biological labels, once captured, complete the fuel cell and the electrons produced are easily measured. Our system is unique in that the fcLFIA actually produces power that is measured, rather than imposing an outside potential and measuring some redox reaction at the capture electrode. The signal is robust, long-lived, and requires only a simple volt meter-like detection system for digitization. Thus, the platform can be quite small and low-power, potentially even solar powered. The principles behind our fcLFIA™ platform, its design, representative data, and its potential to deliver meaningful diagnostic sensitivity in the same simple format as a LFIA will be presented. [1] S.P. Mulvaney, D.A. Kidwell, J.N. Lanese, R.P. Lopez, M.E. Sumera, and E. Wei, “Catalytic Lateral Flow Immunoassays (cLFIA): Amplified Signal in a Self-Contained Assay Format”, Sens. Bio-Sens. Res., 30 (2020) 100390. [2] David Kidwell, “Compact, Electronically-Readable Point-of-Care Immunoassays”, US-20230288412-A1, 09-14-2023.