dbGaP Study Accession: phs003026

NIH Institute/Center: NHLBI

RADx Data Program: RADx Tech

DOI: 10.60773/5061-0a66

Release Date: 09/01/2022

Updated Date: 04/17/2024

Study Description: This was a sub-study of the COVID-19 Test At Home Study. The objective was to gather data on performance of Quidel QuickVue for detection of SARS-CoV-2. This sub-study was used to provide data to Quidel to supplement their existing EUA application for an at-home test. In this study, asymptomatic participants with known close contact to someone who was positive for SARS-CoV-2 infection within the past seven days was asked to self-administer a Quidel QuickVue test and receive a comparator PCR test at the study site on the first day of the study. Thereafter, participants received a test-kit to perform Quidel QuickVue test daily at home, preferably in the morning, for five consecutive days. Participants were asked to return to the study site on day 2 for a second PCR test and on the final day (study day 6). However, if any of the home-tests from days 3-5 resulted as positive or participants developed symptoms and their PCR test result was negative on days 1-2, they were asked to come to the study-site for a comparator PCR test earlier than day 6. Participants were given two additional days to return to the study site if they were unable to come on day 6 for an exit PCR; for those participants, they performed an additional Quidel QuickVue test at home before the standard test at the study site. This means that if they came in on day 6, then no at home test was performed on days 7 and 8. If they came in on day 7 then they performed a test at home on day 7. If they came in on day 8 then they performed a test at home on days 7 and 8. The primary objective of this sub-study was to evaluate the performance (positive percent agreement and negative percent agreement) of the Quidel QuickVue test when self-administered by participants in an unsupervised setting at the study site in comparison to a comparator PCR test performed the same day by study staff. Secondary objectives of this sub-study were to: 1) evaluate the performance (positive percent agreement and negative percent agreement) of the Quidel QuickVue test when self-administered by participants at home in comparison to a comparator PCR performed at the beginning and end of the study and 2) Compare self-reported interpretation of QuickVue test result with interpretation made by a study staff in-person (on day 1) and digitally (days 2-6).

Principal Investigator: Broach, John

Has Data Files: Yes

Study Domain: Medical Device/Tool Development; Self-Testing (At-Home or OTC)

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

Keywords: People with Known COVID Exposure; Asymptomatic Population

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

Study Sites: University of Massachusetts Chan Medical School; Northwestern University and John Hopkins University

Data Types: Behavioral; Questionnaires/Surveys

Study Start Date: 03/25/2021

Study End Date: 12/30/2021

Species: Human Data

Estimated Cohort Size: 200

Study Population Focus: Adults; 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 Northwestern University and John Hopkins University. Data collection occurred through the MyDataHelps Platform managed by the CareEvolution 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 phs003026.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