A field-deployable mobile molecular diagnostic system for malaria at the point of need

In response to the urgent need of a field-deployable and highly sensitive malaria diagnosis, we developed a standalone, sample-in-answer-out molecular diagnostic system (AnyMDx) to enable quantitative molecular analysis of blood-borne malaria in low resource areas. The system consists of a durable battery-powered analyzer and a disposable microfluidic compact disc loaded with reagents ready for use. A low power thermal module and a novel fluorescence-sensing module are integrated into the analyzer for real-time monitoring of loop-mediated isothermal nucleic acid amplification ( LAMP) of target parasite DNA. With 10 mu L of raw blood sample, the AnyMDx system automates the nucleic acid sample preparation and subsequent LAMP and real-time detection. Under laboratory conditions with whole-blood samples spiked with cultured Plasmodium falciparum, we achieved a detection limit of similar to 0.6 parasite per mu L, much lower than those for the conventional microscopy and rapid diagnostic tests (similar to 50-100 parasites per mu L). The turnaround time from sample to answer is less than 40 minutes. The AnyMDx is user-friendly requiring minimal technological training. The analyzer and the disposable reagent compact discs are cost-effective, making AnyMDx a potential tool for malaria molecular diagnosis under field settings for malaria elimination.