Point-of-care (POC) detection technologies that enable decentralized, rapid, sensitive, low-cost diagnostics of COVID-19 infection are urgently needed around the world. With many technologies approved for commercialization in the past 10 months, the field of COVID-19 POC diagnostics is rapidly evolving. In this Perspective, we analyze the current state of POC technologies for the diagnosis and monitoring of COVID-19 infection and discuss future challenges in COVID-19 diagnostics. As the COVID-19 pandemic becomes endemic, the advances gained during this past year will likely also be utilized for future prediction of emerging outbreaks and pandemics.

Rapid, simple, inexpensive, accurate and sensitive point-of-care (POC) detection of viral pathogens in bodily fluids is a vital component of controlling the spread of infectious diseases. The predominant laboratory-based methods...

Since the beginning of the COVID-19 pandemic, several mutations of the SARS-CoV-2 virus have emerged. Current gold standard detection methods for detecting the virus and its variants are based on...

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We report an integrated system for rapid sample-to-answer detection of a viral pathogen in a droplet of whole blood comprised of a two-stage microfluidic cartridge for sample processing and nucleic acid amplification, and a clip-on detection instrument that interfaces with the image sensor of a smartphone. The cartridge is designed to release RNA from the Zika virus in whole blood using chemical lysis, followed by mixing with the assay buffer for performing reverse-transcriptase loop-mediated isothermal amplification (RT-LAMP) reactions in six parallel microfluidic compartments. The battery-powered instrument heats the compartments from below, while LEDs illuminate from above. Fluorescence generation in the compartments is dynamically monitored by a smartphone camera. We characterize the assay time and detection limits for detecting Zika RNA and gamma-irradiated Zika virus spiked into buffer and whole blood and compare the performance of the same assay when conducted in conventional PCR tubes. Our approach for kinetic monitoring of the fluorescence-generating process in the microfluidic compartments enables spatial analysis of early fluorescent “bloom” events for positive samples. We show that dynamic image analysis reduces the time required to designate an assay as a positive test to 22 minutes, compared to ~30-45 minutes for conventional analysis of the average fluorescent intensity of the entire compartment. We achieve a total sample-to-answer time in the range of 17-32 minutes, while demonstrating a viral RNA detection as low as 2.70×102 copies/ul, and a gamma-irradiated virus of 103 virus particles in a single 12.5 microliter droplet blood sample.