SMART‐LAMP: A Smartphone‐Operated Handheld Device for Real‐Time Colorimetric Point‐of‐Care Diagnosis of Infectious Diseases via Loop‐Mediated Isothermal Amplification

Abstract

Nucleic acid amplification diagnostics offer outstanding features of sensitivity and speci-ficity. However, they still lack speed and robustness, require extensive infrastructure, and are nei-ther affordable nor user‐friendly. Thus, they have not been extensively applied in point‐of‐care di-agnostics, particularly in low‐resource settings. In this work, we have combined the loop‐mediated isothermal amplification (LAMP) technology with a handheld portable device (SMART‐LAMP) developed to perform real‐time isothermal nucleic acid amplification reactions, based on simple col-orimetric measurements, all of which are Bluetooth‐controlled by a dedicated smartphone app. We have validated its diagnostic utility regarding different infectious diseases, including Schistosomi-asis, Strongyloidiasis, and COVID‐19, and analyzed clinical samples from suspected COVID‐19 pa-tients. Finally, we have proved that the combination of long‐term stabilized LAMP master mixes, stored and transported at room temperature with our developed SMART‐LAMP device, provides an improvement towards true point‐of‐care diagnosis of infectious diseases in settings with limited infrastructure. Our proposal could be easily adapted to the diagnosis of other infectious diseases.