Instrument-free Lab-on-a-Chip DNA amplification test for pathogen detection

Infectious diseases have been one of the major health hazards in the last decade, and the problem is only aggravated by rising antimicrobial resistance. The availability of diagnostics in clinical laboratories is limited, especially in the developing world, thus, it is imperative to have reliable instrument-free rapid diagnostic tests (RDT). Novel second generation RDTs implement DNA amplification assays with performance metrics matching gold standard PCR tests, but also introduce unique engineering problems. We demonstrate a non instrumented nucleic acid amplification test (NINAAT) platform and detail the solutions that address these challenges. The platform was built around a DNA amplification Lab-on-a-Chip (LOC) with integrated heating via a self-regulating polymer resin PTCR heating element powered by alkaline batteries. The demonstrated prototype was complete with user interfaces required to load the sample and reagents as well as read the output. The prototype was demonstrated to work as a DNA amplification test by detecting chlamydia trachomatis DNA from an aqueous sample via loop-mediated isothermal amplification (LAMP) in the device within 30 minutes in total.