BD Veritor™ At-Home and BD Veritor™ Professional
Clinical Evaluation of The BD Veritor™ At-Home COVID-19 & Flu Test and BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B Assay
1 other identifier
observational
1,146
3 countries
17
Brief Summary
The BD Veritor™ System is a rapid test that is testing for both COVID-19 and for Influenza This study will try to determine if the BD Veritor™ system can assist in the diagnosis of someone who has upper respiratory infection symptoms. There is both an At-Home self test and test completed by a health care professional that will be completed during this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 29, 2022
CompletedStudy Start
First participant enrolled
July 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2023
CompletedJune 7, 2023
June 1, 2023
8 months
April 11, 2022
June 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnostic accuracy of the BD Veritor At-Home Assay
Positive percent agreement of the BD Veritor At-Home Assay compared to an FDA cleared/approved RT-PCR Assay
Immediately after specimen collection
Diagnostic accuracy of the BD Veritor Professional Assay
Positive percent agreement of the BD Professional Assay compared to an FDA cleared/approved RT-PCR Assay
Immediately after specimen collection
Secondary Outcomes (2)
Ease of Use of the BD Veritor At-Home Assay
Within 30 minutes of test completion
Ease of Use of the BD Professional Assay
Within 1 day of first device use
Study Arms (1)
BD Veritor
Each subject will: Self collect a nasal swab for testing on the BD Veritor At-home test (test device) Have a clinician collected nasal swab for testing on the BD Veritor Professional Test (test device) Have a clinical collected nasal swab for testing on an FDA cleared/approved RT-PCR assay (control device)
Interventions
Eligibility Criteria
Individuals presenting with symptoms of acute respiratory illness
You may qualify if:
- \. Participants symptomatic of an acute respiratory illness within 7 DOSO
- \. ≥2 years of age at the time of study participation
- \. Symptomatic subjects with
- a. Any one of the following symptoms (with or without additional symptoms):
- i. Fever
- \. Oral/temporal artery: ≥100.4 °F / ≥38.0 °C
- \. Rectal/Ear: ≥101.2 °F / ≥38.5 °C
- ii. Cough
- iii. Malaise (fatigue/extreme tiredness)
- b. Or two of the following symptoms:
- i. Sore throat,
- ii. Shortness of breath/difficult breathing
- iii. Rhinorrhea (runny or stuffy nose),
- iv. Myalgia,
- v. Headache,
- +3 more criteria
You may not qualify if:
- \. Participants currently undergoing treatment and/or within the past thirty (30) days of the study, with medication to treat novel Coronavirus SARS-CoV-2 viral infections, which may include but is not limited to Remdesivir (Veklury)
- \. Participants receiving convalescent plasma therapy for SARS-CoV-2.
- \. Participants who have received antiviral medications for influenza within the previous 30 days.
- \. Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit.
- \. The participant is currently receiving or has received within the past thirty (30) days of the study visit, an experimental biologic or drug including either treatment or therapy.
- \. Participants who have been previously enrolled in the study.
- \. History of frequent or difficult to control nosebleeds within the last fourteen (14) days.
- \. Participants who have tested positive for Flu A/B or SARS-CoV-2 within the last 28 days (excluding the day of enrollment in the study).
- \. Participants without the ability to read or write in the English Language
- \. Participants with prior medical or laboratory training.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
CTMD Research
Coconut Creek, Florida, 33063, United States
CTMD Research
Palm Springs, Florida, 33406, United States
DBC Research
Pembroke Pines, Florida, 33029, United States
CTMD Reserarch
Asheville, North Carolina, 28804, United States
Kur Research - AFC Urgent Care
Easley, South Carolina, 29640, United States
Kur Research - AFC Urgent Care
Powdersville, South Carolina, 29611, United States
Kur Research - AFC Urgent Care
Seneca, South Carolina, 29678, United States
Kur Research - Complete Health Partners
Hendersonville, Tennessee, 37075, United States
Kur Research - Complete Health Partners
Nashville, Tennessee, 37209, United States
University of the Sunshine Coast
Sippy Downs, Queensland, 4556, Australia
Southern Clinical Trials - Totara
Auckland, 0600, New Zealand
Optimal Clinical Trials
Auckland, 1010, New Zealand
Southern Clinical Trials - Remuera
Auckland, 1050, New Zealand
Lakeland Clinical Trials - Waikato
Hamilton, 3200, New Zealand
Southern Clinical Trials - Tasman
Nelson, 7011, New Zealand
Silverdale Medical Ltd
Silverdale, 0932, New Zealand
Southern Clinical Trials - Wellington
Upper Hutt, 5018, New Zealand
Biospecimen
Self-collected and clinician collected nasal swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2022
First Posted
April 29, 2022
Study Start
July 21, 2022
Primary Completion
March 9, 2023
Study Completion
April 14, 2023
Last Updated
June 7, 2023
Record last verified: 2023-06