dbGaP Study Accession: phs002737

NIH Institute/Center: NHLBI

RADx Data Program: RADx Tech

Release Date: 08/12/2022

DOI: 10.60773/wqc5-e480

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: Medical Device or Tool Development; Point-of-Care (POC) Testing

Data Collection Method: Molecular Nucleic Acid or PCR Testing Device; Smartphone; Survey

Keywords: Near Patient Testing; Symptomatic Population

Study Design: Device Validation

Multi-Center Study: Yes

Study Sites: UMass Chan Medical School; University of Iowa; University of Kansas; Oregon Rural Practice-based Research Network

Data Types: Clinical; Questionnaire or Survey

Study Start Date: 03/10/2021

Study End Date: 09/21/2021

Species: Human

Estimated Cohort Size: 285

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

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