dbGaP Study Accession: phs002682

NIH Institute/Center: NIBIB

RADx Data Program: RADx Tech

Release Date: 08/12/2022

DOI: 10.60773/54ae-xy13

Study Description: There are two device studies under the 2183 banner. The 2183b study used an enhanced visual display compared to the original study (2183a), so it has been renamed. These prospective clinical studies sought to examine the performance of the 2183 device (a and b), a lateral flow immunoassay for the point-of-care (POC) detection of SARS-CoV-2 nucleocapsid protein antigen, compared to the Roche 6800 Cobas PCR for SARS-CoV-2 assay. The goal of the 2183b study was for EUA approval for the device to be used among symptomatic persons by trained healthcare personnel collected mid-turbinate specimens. Note: no device performance data will be included in the data files.

Updated Date: 04/09/2024

Principal Investigator: Gibson, Laura

Has Data Files: Yes

Study Domain: Medical Device or Tool Development; Point-of-Care (POC) Testing; Rapid Diagnostic Test (RDT)

Data Collection Method: Antigen Testing Device; Survey

Keywords: Near Patient Testing

Study Design: Device Validation

Multi-Center Study: Yes

Study Sites: UMass Chan Medical School and Northwestern University

Data Types: Clinical; Questionnaire or Survey

Study Start Date: 10/16/2020

Study End Date: 11/06/2020

Species: Human

Estimated Cohort Size: 488

Study Population Focus: N/A

Acknowledgement Statement: This study was supported through funding, 75N92020C00020-P00001-9999-1, 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. Additional recruitment of participants occurred at Northwestern 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 phs002682.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.

NIH Grant or Contract Number(s): 75N92020C00020-P00001-9999-1

Consent/Data Use Limitations: General Research Use