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Mobile all-in-one malaria molecular diagnosis for field deployment in resource-limited areas

This paper presents a "sample-in-answer-out" molecular diagnostic system (AnyMDx) for blood-born malaria detection at the point of care, especially in resource-limiting settings. AnyMDx consists of a microfluidic reagent compact disk incorporating seamlessly integrated steps of DNA extraction, purification, elution, and amplification, as well as a mobile battery-powered analyzer. Low power thermal module and novel fluorescence sensing module are integrated into the analyzer for real-time monitoring of loop-mediated isothermal nucleic acid amplification (LAMP). The AnyMDx has an assay detection limit of ~0.6 parasites/μL against blood P. falciparum parasites, much lower than conventional microscope-based method (~50 parasites/μL) and immunoassay based RTD (~100 parasites/μL). AnyMDx is fully automated and thus is easily accessible to non-specialist with minimal molecular training. The sample-to-answer turnaround time for AnyMDx is less than 40 minutes.