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

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.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Infection
• Intervention / Treatment: Diagnostic test: BD Veritor At-Home; Diagnostic test: BD Veritor Professional

Detailed Description

This is a prospective, multi-country, multicenter, comparative study to assess the performance of the BD Veritor™ At-Home SARS-CoV-2 & Flu A+B test and the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B (Professional use) compared to an FDA approved Flu A/B reference assay (RT-PCR) and FDA authorized molecular SARS-CoV-2 comparator reference method assays.

• Study Type: Observational
• Enrollment (Actual): 1146

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Sippy Downs, Queensland, Australia, 4556
      • University of the Sunshine Coast
• New Zealand
  • Auckland, New Zealand, 1010
    • Optimal Clinical Trials
  • Auckland, New Zealand, 0600
    • Southern Clinical Trials - Totara
  • Auckland, New Zealand, 1050
    • Southern Clinical Trials - Remuera
  • Hamilton, New Zealand, 3200
    • Lakeland Clinical Trials - Waikato
  • Nelson, New Zealand, 7011
    • Southern Clinical Trials - Tasman
  • Silverdale, New Zealand, 0932
    • Silverdale Medical Ltd
  • Upper Hutt, New Zealand, 5018
    • Southern Clinical Trials - Wellington
• United States
  • Florida
    • Coconut Creek, Florida, United States, 33063
      • CTMD Research
    • Palm Springs, Florida, United States, 33406
      • CTMD Research
    • Pembroke Pines, Florida, United States, 33029
      • DBC Research
  • North Carolina
    • Asheville, North Carolina, United States, 28804
      • CTMD Reserarch
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • Kur Research - AFC Urgent Care
    • Powdersville, South Carolina, United States, 29611
      • Kur Research - AFC Urgent Care
    • Seneca, South Carolina, United States, 29678
      • Kur Research - AFC Urgent Care
  • Tennessee
    • Hendersonville, Tennessee, United States, 37075
      • Kur Research - Complete Health Partners
    • Nashville, Tennessee, United States, 37209
      • Kur Research - Complete Health Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals presenting with symptoms of acute respiratory illness

Description

Inclusion Criteria:

• 1. Participants symptomatic of an acute respiratory illness within 7 DOSO
• 2. ≥2 years of age at the time of study participation
• 3. Symptomatic subjects with
• a. Any one of the following symptoms (with or without additional symptoms):
• i. Fever
• 1. Oral/temporal artery: ≥100.4 °F / ≥38.0 °C
• 2. 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,
• vi. Sneezing,
• vii. New loss of taste or smell,
• viii. One or more GI symptoms (nausea, vomiting, diarrhea)

Exclusion Criteria:

• 1. 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)
• 2. Participants receiving convalescent plasma therapy for SARS-CoV-2.
• 3. Participants who have received antiviral medications for influenza within the previous 30 days.
• 4. Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit.
• 5. 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.
• 6. Participants who have been previously enrolled in the study.
• 7. History of frequent or difficult to control nosebleeds within the last fourteen (14) days.
• 8. 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).

Exclusion criteria for the participation in the At-Home portion of the study would include all of the criteria previously listed and include the following

• 1. Participants without the ability to read or write in the English Language
• 2. Participants with prior medical or laboratory training.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Diagnostic test: BD Veritor At-Home; BD Veritor At-Home rapid self testing; Diagnostic test: BD Veritor Professional; BD Veritor Professional rapid test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Use of the BD Veritor At-Home Assay	Subject completed 5-Point Likert scale rating ease of use where 1 indicates difficult and 5 indicates easy	Within 30 minutes of test completion
Ease of Use of the BD Professional Assay	Clinician completed 5-Point Likert scale rating ease of use where 1 indicates difficult and 5 indicates easy	Within 1 day of first device use

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Influenza; SARS COV 2
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: IDS-VERTPPGEN2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes