dbGaP Study Accession: phs002737
NIH Institute/Center: NHLBI
RADx Data Program: RADx Tech
DOI: 10.60773/wqc5-e480
Release Date: 08/12/2022
Study Description: The purpose of this study was to test the performance of the Saliva Test device in detecting SARS-CoV-2 in symptomatic people for Emergency Use Authorization (EUA) as a point-of-care (POC) test. The 2322 Saliva Test was a rapid real-time RT-PCR test intended for the qualitative detection of RNA from the SARS-CoV-2 virus in saliva specimens from individuals suspected of SARS-CoV-2 infection by a healthcare professional. There were three studies under the banner of 2322 (2322a, 2322b1, and 2322b2). The test device underwent algorithmic changes after 2322a and thus was renamed 2322b. After partial enrollment eligibility criteria widened and the 2322b study adopted a 1 or 2 to designate the change in eligibility. 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: Point-of-Care (POC) Testing; Medical Device/Tool Development
Data Collection Method: Survey; Smartphone; Molecular (Nucleic Acid/PCR) Testing Device
Keywords: Near Patient Testing; Symptomatic Population
Study Design: Device Validation Study
Multi-Center Study: TRUE
Study Sites: UMass Chan Medical School; University of Iowa; University of Kansas; Oregon Rural Practice-based Research Network
Data Types: Clinical; Questionnaires/Surveys
Study Start Date: 03/10/2021
Study End Date: 09/21/2021
Species: Human Data
Estimated Cohort Size: 285
Study Population Focus: Children; Older Adults or Elderly; Adults
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 University of Iowa, University of Kansas, and the Oregon Rural Practice-based Research Network. 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 phs002737.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