Abstract
In point-of-care testing (POCT), tests are performed near patients and results are given rapidly for timely clinical decisions. Immunodiagnostic assays are one of the most important analyses for detecting and quantifying protein-based biomarkers. However, existing POCT immunodiagnostics mainly rely on the lateral flow assay (LFA), which has limited sensitivity or quantification capability. Although other immunodiagnostic assays, such as enzyme-linked immunosorbent assays (ELISAs), offer more sensitive and quantitative results, they require complex liquid manipulations that are difficult to implement in POCT settings by conventional means. Here, we show the development of DropLab, an automated sample-in-answer-out POCT immunodiagnostic platform based on magnetic digital microfluidic (MDM) technology. DropLab performs microbead-based ELISA in droplets to offer more sensitive and quantitative testing results. The intricate liquid manipulations required for ELISA are accomplished by controlling droplets with magnetic microbeads using MDM technology, which enables us to achieve full automation and easy operations with DropLab. Four ELISAs (the sample in triplicates and a negative control) can be run in parallel on the thermoformed disposable chip, which greatly improves the throughput and accuracy compared to those of other POCT immunodiagnostic devices. DropLab was validated by measuring two protein targets and one antibody target. The testing results showed that the limit of detection (LOD) of DropLab matched that of the conventional ELISA in a microwell plate. DropLab brings MDM one step closer to being a viable medical technology that is ready for real-world POCT applications.