Paper-based microfluidic electro-analytical device (PMED) for magneto-assay automation: Towards generic point-of-care diagnostic devices.

Rapid diagnostic tests (RDTs) for point-of-care (POC) testing of infectious diseases are popular because they are easy to use. However, RDTs have limitations such as low sensitivity and qualitative responses that rely on subjective visual interpretation. Additionally, RDTs are made using paper-bound reagents, which leads to batch-to-batch variability, limited storage stability and detection of only the analytes they were designed for. This work presents the development of a versatile technology, based on short magneto-assays and inexpensive paper-based microfluidic electro-analytical devices (PMEDs). PMEDs were produced locally using low-cost equipment, they were stable at room temperature, easy to use, and provided quantitative and objective results. The devices served to detect alternatively a variety of magneto-assays, granting quantitation of streptavidin-HRP, biotinylated HRP and Pasmodium falciparum lactate dehydrogenase (Pf-LDH) in less than 25 min, using either commercial or customized screen-printed electrodes and measurement equipment. Furthermore, Pf-LDH detection in diluted lysed whole blood displayed a linear response between 3 and 25 ng mL⁻¹, detection and quantification limits ranging between 1 and 3 ng mL⁻¹ and 6–12 ng mL⁻¹, respectively, and provided results that correlated with those of the reference ELISA. In short, this technology is versatile, simple, and highly cost-effective, making it perfect for POC testing.