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

PROJECT SUMMARYRobust, efficient and reliable testing for SARS-CoV-2 is extraordinarily challenging due to our lack of ultra-sensitive assays and ever evolving knowledge of the virus. Standard PCR based assays still result in very highfalse negative rates in the earliest days of infection. Microfluidic processing of clinical samples is low cost andshows great promise for translating most liquid biopsy assay to the clinic. Our laboratory was one of the first toapply microfluidic technologies for the isolation of both circulating tumor cells and exosomes in the blood ofpatients with cancer. For SARS-CoV-2 patients, saliva, stool, and plasma are all thought to be potential resourcesfor both virus detection as well as other clinical biomarkers that might inform us of infection. Thus, for this U18,we will optimize our exosome capture technology, the EVHB-Chip, for the isolation of intact SARS-CoV-2 virus,testing its utility for each of these biofluids. To complete this work, we will complete a full clinical validation andbenchmarking of the assay. Once fully optimized, our detection assay will be compared against existing EUASARS-CoV-2 detection assay to determine detection sensitivity and specificity. Further, we plan to demonstratethat the increased sensitivity and specificity enabled by our microfluidic device will result in earlier detection ofSARS-CoV-2, reducing false negatives in this testing window. At the completion of this work, we will havecollected the data training sets and submitted a full EUA plan that would enable the FDA's authorization of ourtest to be used in the clinic.