dbGaP Study Accession: phs002738

NIH Institute/Center: NHLBI

RADx Data Program: RADx Tech

Release Date: 08/12/2022

DOI: 10.60773/5ff3-nc70

Study Description: The 5534 prospective clinical study sought to examine the performance of the 5534 device, for the detection of SARS-CoV-2 nucleocapsid protein antigen compared to the Roche 6800 Cobas PCR for SARS-CoV-2 assay. The goal of the 5534 study was for EUA approval for the device to use among symptomatic persons by trained healthcare personnel collected nasal, saliva, and dried bloodspot specimens. Note: no device performance data were included in the dataset.

Updated Date: 04/17/2024

Principal Investigator: Gibson, Laura

Has Data Files: Yes

Study Domain: Diagnostic Testing; Virological Testing; Medical Device/Tool Development

Data Collection Method: Antigen Testing Device; Survey; Smartphone

Keywords: Near Patient Testing; Symptomatic Population

Study Design: Device Verification Study

Multi-Center Study: No

Study Sites: Emory University

Data Types: Clinical; Questionnaires/Surveys

Study Start Date: 11/03/2020

Study End Date: 01/12/2021

Species: Human Data

Estimated Cohort Size: 187

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

Acknowledgement Statement: This study was supported through funding, 5U54HL143541-04, 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. Additional recruitment of participants occurred at Emory University. Data collection occurred through the Eureka Platform managed by the UCSF 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 phs002738.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: PAR-17-453

NIH Grant or Contract Number(s): 5U54HL143541-04

Consent/Data Use Limitations: General Research Use