dbGaP Study Accession: phs003124

NIH Institute/Center: NCATS

RADx Data Program: RADx-rad

Release Date: 08/30/2024

DOI: 10.60773/yn52-cp83

Study Description: 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, this study proposed 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 3 h), and practical. The device was optimized to analyze blood, saliva, and nasopharyngeal (NP) swabs collected at home, without risking transmission to healthcare workers. The sample is processed with an automated device developed with Sognef, 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, plus a panel of host EV microRNAs (exomiRs) that reveals infection even when viral loads are below detectable limits. This approach decreased false-positives/negatives, the major limitation of antigen/antibody tests. Examine relationships of miRNA panels with characteristics such as: symptomatic vs asymptomatic, qPCR-determined viral load, biological sex, age (including pediatric populations), and comorbidities. The study optimized a COVID-19 device that uses simple bind-elute microfluidics for sample separation followed by electrical, probe-based detection of i) all validated exomiRs from Aim 1 and ii) three conserved vRNAs. It is envisioned that the device will be used first for either finger-pricked blood or saliva, followed, if positive, by an optional confirmatory second test of NP swab viral transport medium (VTM) that could be done with the same device. The device was tested in multiple centers worldwide in two phases: Phase 1 – every center will perform a double-blinded validation using their biorepository specimen, and Phase 2 – in a β-testing phase, the study provided a large number of devices to healthcare providers for regular testing of workers.

Updated Date: 11/28/2022

Principal Investigator: Das, Samarjit

Has Data Files: No

Study Domain: Rapid Diagnostic Test (RDT); Digital Health Applications; Medical Device/Tool Development; Self-Testing (At-Home or OTC)

Data Collection Method: Biobank Samples

Keywords: Multiparametric Detection; Microfluidics; mHealth; Extracellular Vesicle (EV) Separation and Characterization Technologies

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

Study Sites: Sognef Inc

Data Types: Clinical; Other

Data Types, Other: COVID-19 positive and COVID-19 negative saliva samples

Study Start Date: 12/21/2020

Study End Date: 03/31/2022

Species: Human Data

Estimated Cohort Size: 0

Study Population Focus: N/A

Acknowledgement Statement: This study was supported through funding, 3U18TR003780-02S1, for the National Center for Advancing Translational Sciences (NCATS) as part of the RADx-rad program. Approved users should acknowledge the provision of data access by dbGaP for accession phs003124.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-272

NIH Grant or Contract Number(s): 3U18TR003780-02S1

Consent/Data Use Limitations: Use of the data is limited to health/medical/biomedical purposes