dbGaP Study Accession: phs003237
NIH Institute/Center: NIBIB
RADx Data Program: RADx Tech
Release Date: 04/13/2023
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: Self-Testing (At-Home or OTC); Rapid Diagnostic Test (RDT)
Data Collection Method: Molecular (Nucleic Acid/PCR) Testing Device; Survey; Antigen Testing Device
Keywords: Symptomatic Population; Testing Effectiveness; Asymptomatic Population
Study Design: Longitudinal Cohort
Multi-Center Study: FALSE
Data Types: Behavioral; Questionnaires/Surveys
Study Start Date: 10/18/2021
Study End Date: 03/31/2022
Species: Human Data
Estimated Cohort Size: 7361
Study Population Focus: Children; Adults; 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