dbGaP Study Accession: phs003237

NIH Institute/Center: NIBIB

RADx Data Program: RADx Tech

Release Date: 04/13/2023

DOI: 10.60773/0va3-6933

Study Description: Objective: To evaluate performance of Ag-RDT for detection of SARS-CoV-2 in relation to onset of infection for symptomatic and asymptomatic participants. Design, Setting, and Participants: Prospective cohort study conducted from October 2021 to February 2022 among participants > 2 years-old from across the US who enrolled using a smartphone app. During each testing encounter, participants self-collected one nasal swab and performed Ag-RDT at home; at-least fifteen minutes later, a second nasal swab was self-collected and shipped for SARS-CoV-2 RT-PCR at a central lab. Both nasal swabs were collected 7 times at 48-hour intervals (over approximately 14 days) followed by an extra nasal swab collection with home Ag-RDT test 48-hours after their last PCR sample. Each participant was assigned to one of the three emergency use authorized (EUA) Ag-RDT tests used in this study. This analysis was limited to participants who were asymptomatic and tested negative by antigen and molecular tests on their first day of study participation.

Updated Date: 04/17/2024

Principal Investigator: Soni, Apurv

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Rapid Diagnostic Test (RDT)

Data Collection Method: Antigen Testing Device; Molecular Nucleic Acid or PCR Testing Device; Survey

Keywords: Asymptomatic Population; Symptomatic Population; Testing Effectiveness

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Behavioral; Questionnaire or Survey

Study Start Date: 10/18/2021

Study End Date: 03/31/2022

Species: Human

Sample Size: 7336

Study Population Focus: Adults; Children; Older Adults or Elderly

Acknowledgement Statement: This study was supported through funding, 3U54HL143541-05S1, for the National Heart Lung and Blood Institute (NHLBI) as part of the RADx Tech program. Operations support and data management occurred primarily through the UMass Chan Medical School’s Center for Clinical and Translational Science, Clinical Studies Core, and the Department of Population and Quantitative Health Sciences. Data collection occurred through the MyDataHelps Platform managed by the CareEvolution team. Quest Diagnostics ran the standard comparators (Roche 6800 Cobas PCR for SARS-CoV-2 assays). Approved users should acknowledge the provision of data access by dbGaP for accession phs003237.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): 3U54HL143541-05S1

Consent/Data Use Limitations: General Research Use