dbGaP Study Accession: phs002736

NIH Institute/Center: NHLBI

RADx Data Program: RADx Tech

DOI: 10.60773/2seb-yr47

Release Date: 08/12/2022

Updated Date: 04/17/2024

Study Description: This prospective clinical study sought to examine the performance of the device, a sample-to-answer nucleic acid PCR amplification platform solution for the point-of-care (POC) detection of SARS-CoV-2, compared to the Roche 6800 Cobas PCR for SARS-CoV-2 assay. Secondary outcomes include usability and interpretability of results among POC device operators. The goal of this study was to extend the existing EUA approval that the device has (symptomatic participants and healthcare provider obtained specimens) to use among asymptomatic persons and using self-collected mid-turbinate specimens. Note: no device performance data were included in the dataset.

Principal Investigator: Gibson, Laura

Has Data Files: Yes

Study Domain: Medical Device/Tool Development; Point-of-Care (POC) Testing

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

Keywords: Near Patient Testing

Study Design: Device Validation Study

Multi-Center Study: No

Study Sites: UMass Chan Medical School

Data Types: Questionnaires/Surveys; Clinical

Study Start Date: 08/24/2020

Study End Date: 10/30/2020

Species: Human Data

Estimated Cohort Size: 341

Study Population Focus: N/A

Acknowledgement Statement: This study was supported through funding, 5U54HL143541-03, 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 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 phs002736.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): 5U54HL143541-03

Consent/Data Use Limitations: General Research Use