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Clinical Evaluation of BD Veritor™ At-Home and BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B Assay

Sponsor
Becton, Dickinson and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05352581
Collaborator
(none)
3,000
Enrollment
10
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of the BD Veritor At-Home Assay [Immediately after specimen collection]

    Positive percent agreement of the BD Veritor At-Home Assay compared to an FDA cleared/approved RT-PCR Assay

  2. Diagnostic accuracy of the BD Veritor Professional Assay [Immediately after specimen collection]

    Positive percent agreement of the BD Professional Assay compared to an FDA cleared/approved RT-PCR Assay

Secondary Outcome Measures

  1. Ease of Use of the BD Veritor At-Home Assay [Within 30 minutes of test completion]

    Subject completed 5-Point Likert scale rating ease of use where 1 indicates difficult and 5 indicates easy

  2. Ease of Use of the BD Professional Assay [Within 1 day of first device use]

    Clinician completed 5-Point Likert scale rating ease of use where 1 indicates difficult and 5 indicates easy

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Participants symptomatic of an acute respiratory illness within 7 DOSO
    1. ≥2 years of age at the time of study participation
    1. Symptomatic subjects with
    1. Any one of the following symptoms (with or without additional symptoms):
    1. Fever
    1. Oral/temporal artery: ≥100.4 °F / ≥38.0 °C
    1. Rectal/Ear: ≥101.2 °F / ≥38.5 °C
    1. Cough
    1. Malaise (fatigue/extreme tiredness)
    1. Or two of the following symptoms:
    1. Sore throat,
    1. Shortness of breath/difficult breathing
    1. Rhinorrhea (runny or stuffy nose),
    1. Myalgia,
    1. Headache,
    1. Sneezing,
    1. New loss of taste or smell,
    1. 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)
    1. Participants receiving convalescent plasma therapy for SARS-CoV-2.
    1. Participants who have received antiviral medications for influenza within the previous 30 days.
    1. Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit.
    1. 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.
    1. Participants who have been previously enrolled in the study.
    1. History of frequent or difficult to control nosebleeds within the last fourteen (14) days.
    1. 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
    1. Participants with prior medical or laboratory training.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Becton, Dickinson and Company

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Becton, Dickinson and Company
ClinicalTrials.gov Identifier:
NCT05352581
Other Study ID Numbers:
  • IDS-VERTPPGEN2
First Posted:
Apr 29, 2022
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
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
Keywords provided by Becton, Dickinson and Company
SARS COV 2
Influenza
Additional relevant MeSH terms:
Respiratory Tract Infections

Study Results

No Results Posted as of Apr 29, 2022