dbGaP Study Accession: phs003239

NIH Institute/Center: NIBIB

RADx Data Program: RADx Tech

Release Date: 04/13/2023

DOI: 10.60773/k8wj-0k62

Study Description: Symptomatic or close-contact participants were enrolled and asked to perform daily tests for 10 days. Each participant performed a rapid antigen test (Quidel or Abbott) followed by home-based sample collection and subsequent highly sensitive RT-qPCR assay (Roche, LOD = 1,800 NDU/mL) performed in a CLIA-certified lab.

Updated Date: 04/17/2024

Principal Investigator: Soni, Apurv

Has Data Files: Yes

Study Domain: Rapid Diagnostic Test (RDT)

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

Keywords: Symptomatic Population; People with Known COVID Exposure

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Behavioral; Questionnaires/Surveys

Study Start Date: 01/19/2022

Study End Date: 04/30/2022

Species: Human Data

Estimated Cohort Size: 619

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

Acknowledgement Statement: This study was supported through funding, 3U54HL143541-05S1, for the National Institute of Biomedical Imaging and Bioengineering (NIBIB) 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 phs003239.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