BD Veritor™ At-Home and BD Veritor™ Professional

Completed

• Conditions: Upper Respiratory Infection
• Interventions: Diagnostic Test: BD Veritor At-Home; Diagnostic Test: BD Veritor Professional

• Registration Number: NCT05352581
• Lead Sponsor: Becton, Dickinson and Company

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.

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 Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Study Start: 2022-07-21
• Primary Completion: 2023-03-09
• Study Completion: 2023-04-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1146

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)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BD Veritor	BD Veritor Professional	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)
BD Veritor	BD Veritor At-Home	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)

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
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
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

Trial Locations

Locations (13)

Southern Clinical Trials - Tasman; 🇳🇿 Nelson, New Zealand

Southern Clinical Trials - Totara; 🇳🇿 Auckland, New Zealand

Lakeland Clinical Trials - Waikato; 🇳🇿 Hamilton, New Zealand

Southern Clinical Trials - Wellington; 🇳🇿 Upper Hutt, New Zealand

Silverdale Medical Ltd; 🇳🇿 Silverdale, New Zealand

Optimal Clinical Trials; 🇳🇿 Auckland, New Zealand

Southern Clinical Trials - Remuera; 🇳🇿 Auckland, New Zealand

DBC Research; 🇺🇸 Pembroke Pines, Florida, United States

CTMD Reserarch; 🇺🇸 Asheville, North Carolina, United States

Kur Research - Complete Health Partners; 🇺🇸 Nashville, Tennessee, United States

CTMD Research; 🇺🇸 Palm Springs, Florida, United States

Kur Research - AFC Urgent Care; 🇺🇸 Seneca, South Carolina, United States

University of the Sunshine Coast; 🇦🇺 Sippy Downs, Queensland, Australia