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Principal Investigator: Samarjit Das
Organization: JOHNS HOPKINS UNIVERSITY
Fiscal Year: 2022
Award: $500,000
Funding agency: National Center for Advancing Translational Sciences
Abstract
This supplement is in response to Funding Opportunity Announcement Number PA-20-272
Administrative Supplements to Existing NIH Grants and Cooperative Agreements. The
supplement application is in response to the RADx-rad announcement on the opportunity of
additional resources and funding support to facilitate the pathway to commercialization. The
opportunity was announced by the RADx-rad Data Coordination Center (DCC) and relayed
through the NIH SEED office.
The urgent need to curb the spread of SARS-CoV-2 demands availability of diagnostics that are
more rapid, accurate, sensitive and affordable than qPCR and antibody tests. Current qPCR tests
are specific and sensitive, but lengthy turnaround times limit interventions against disease spread.
Antibody testing is faster, but false-positive/negative rates are high. Here, we propose to
repurpose extracellular vesicle (EV) separation and characterization technologies into a fully
automated SARS-CoV-2 testing platform that is low-cost, accurate, sensitive, rapid (within 5 min),
and practical. The device has been optimized to analyze blood, saliva, and nasopharyngeal (NP)
swabs. However, in this proposal we will be focusing on saliva or drooling samples (25-50 ul) that
can be easily self-obtained at-home setting. The sample is processed with an automated device
developed with Sognef Inc., and data are transferred to the Sognef servers for analysis through
an app that can be downloaded to any smart device. This technology is similar to Abbott's recently
launched BinaxNOW COVID-19 Ag Card, but has the advantage of multiparametric detection of
viral RNA (vRNA), including Spike (S) and Nucleocapsid (N) protein-coding regions that reveals
infection even when viral loads are below detectable limits. This approach will decrease false-
positives/negatives, the major limitation of antigen/antibody tests.
Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><Administrative Supplement><Adoption><Age><Antibodies><Antigens><Authorization><Authorization documentation><Award><Back><Binding><Blood><Blood Reticuloendothelial System><COVID-19><COVID-19 detection><COVID-19 testing><COVID-19 virus><COVID19><COVID19 detection><COVID19 testing><COVID19 virus><CV-19><CV19><Caliber><Cell Body><Cell Communication><Cell Communication and Signaling><Cell Interaction><Cell Signaling><Cell surface><Cell-to-Cell Interaction><Cells><Clinical><Clinical Trials><CoV-2><CoV2><Conduct Clinical Trials><Cooperative Agreements><Data><Data Coordinating Center><Data Coordination Center><Detection><Devices><Diagnostic><Diameter><Disease><Disorder><Dorsum><Drooling><Engineering><Equipment><FDA EUA><FDA Emergency Use Authorization><Food and Drug Administration EUA><Food and Drug Administration Emergency Use Authorization><Funding><Funding Opportunities><Grant><Home><Infection><Intervention><Intervention Strategies><Intracellular Communication and Signaling><Lipids><Manuals><Mediator><Mediator of Activation><Mediator of activation protein><Methodology><Modification><Molecular Interaction><NIH><National Institutes of Health><Non-Polyadenylated RNA><Nucleocapsid Proteins><ORFs><Open Reading Frames><Organism-Level Process><Organismal Process><Parents><Pathologic Processes><Pathological Processes><Pathway interactions><Permission><Physiologic Processes><Physiological Processes><Process><Production><Protein Coding Region><Proteins><RADx Radical><RADx-rad><RNA><RNA Gene Products><Rapid Acceleration of Diagnostics Radical><Reagent><Research Contracts><Research Resources><Resources><Ribonucleic Acid><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV-2 detection><SARS-CoV-2 testing><SARS-CoV2><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Saliva><Sampling><Semiconductors><Sensitivity and Specificity><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome related corona virus 2><Signal Transduction><Signal Transduction Systems><Signaling><Technology><Testing><Time><TimeLine><U-Series Cooperative Agreements><United States National Institutes of Health><Validation><Viral><Viral Burden><Viral Load><Viral Load result><Virion><Virus Particle><Wuhan coronavirus><ages><base><biological signal transduction><combat><commercialization><corona virus disease 2019><coronavirus disease 2019><coronavirus disease 2019 detection><coronavirus disease 2019 testing><coronavirus disease 2019 virus><coronavirus disease-19><coronavirus disease-19 virus><coronavirus infectious disease-19><cost><data exchange><data transfer><data transmission><detect COVID-19><detect COVID19><detect SARS-CoV-2><detect severe acute respiratory syndrome coronavirus 2><emergency use authorization><exosome><extracellular vesicles><hCoV19><immunogen><interventional strategy><member><microbial><microelectronics><microvesicles><nCoV2><nasopharyngeal swab><novel><pandemic><pandemic disease><particle><pathway><pre-clinical><pre-clinical study><precision medicine><precision-based medicine><preclinical><preclinical study><programs><response><saliva sample><salivary sample><scale up><screening><severe acute respiratory syndrome coronavirus 2 detection><severe acute respiratory syndrome coronavirus 2 testing><usability><user-friendly><viral RNA><viral detection><virus RNA><virus detection>