dbGaP Study Accession: phs002778

NIH Institute/Center: NCATS

RADx Data Program: RADx-rad

DOI: 10.60773/1e6t-6b11

Release Date: 07/20/2022

Study Description: Robust, efficient and reliable testing for SARS-CoV-2 is extraordinarily challenging due to lack of ultra- sensitive assays and ever evolving knowledge of the virus. Standard PCR based assays still result in very high false negative rates in the earliest days of infection. Microfluidic processing of clinical samples is low cost and shows great promise for translating most liquid biopsy assay to the clinic. This laboratory was one of the first to apply microfluidic technologies for the isolation of both circulating tumor cells and exosomes in the blood of patients with cancer. For SARS-CoV-2 patients, saliva, stool, and plasma are all thought to be potential resources for both virus detection as well as other clinical biomarkers that might inform us of infection. Thus, for this U18, the study optimized 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, this study completed a full clinical validation and benchmarking of the assay. Once fully optimized, the detection assay was compared against existing EUA SARS-CoV-2 detection assay to determine detection sensitivity and specificity. Further, the study planned to demonstrate that the increased sensitivity and specificity enabled by the microfluidic device would result in earlier detection of SARS-CoV-2, reducing false negatives in this testing window. At the completion of this work, the study collected the data training sets and submitted a full EUA plan that would enable the FDA's authorization of the test to be used in the clinic.

Updated Date: 05/16/2023

Principal Investigator: Stott, Shannon L

Has Data Files: Yes

Study Domain: Medical Device/Tool Development; Virological Testing

Data Collection Method: Molecular (Nucleic Acid/PCR) Testing Device

Keywords: SARS-CoV-2 Infection; Saliva; Sensitivity and Specificity; Whole Blood; Acute Infection; Assay Development; Clinical Biomarkers; Cost; Cross Reactivity; Detection Assay; Detection Limit; Detection Sensitivity; Disease Phenotype; Exosome; Liquid Biopsy; Microfluidic Technology; Molecular Diagnostics; Novel Strategies; Preservation; Research Clinical Testing; Exosome based; Pathway Interactions; Authorization; Benchmarking; Biological Assay; CLIA-Certified; COVID-19 Early Detection; Cancer Center; Convalescence; Immunology; Malignant Neoplasms; Microfluidics; Plasma; RNA; Radiologic Health

Study Design: Case-Control

Multi-Center Study: FALSE

Data Types: Genotyping

Study Start Date: 12/21/2020

Study End Date: 02/28/2022

Species: Human Data

Estimated Cohort Size: 200

Study Population Focus: N/A

Acknowledgement Statement: This study was supported through funding, 4U18TR003793-02, for the National Center for Advancing Translational Sciences (NCATS) as part of the RADx-rad program. We would like to acknowledge Mass General Brigham Biobank for providing samples, genomic data, and health information data. Approved users should acknowledge the provision of data access by dbGaP for accession phs002778.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: RFA-OD-20-018

NIH Grant or Contract Number(s): 4U18TR003793-02

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