Microfluidic Isolation and Characterization of SARS-CoV-2 and Virus Related Exosomes

Background: Robust, efficient, and reliable testing for SARS-CoV-2 was extraordinarily challenging due to lack of ultra-sensitive assays and ever evolving knowledge of the virus. For SARS-CoV-2 patients, saliva, stool, and plasma were thought to be potential resources for both virus detection as well as other clinical biomarkers that might inform infection. Materials/Methods: This study optimized exosome capture technology, the EVHB-Chip, for the isolation of intact SARS-CoV-2 virus, testing its utility for each of the biofluids. The study completed a full clinical validation and benchmarking of the assay. After the assay was fully optimized, it was compared against existing detection assays to determine sensitivity and specificity. Outcome/Impact: The study submitted a full Emergency Use Authorization plan to enable the FDA's authorization of the test to be used in the clinic. The study demonstrated that the increased sensitivity and specificity enabled by the microfluidic device would result in earlier detection of SARS-CoV-2 and reduce false negatives in the testing window.