BD Veritor™ At-Home and BD Veritor™ Professional

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Upper Respiratory Infection

Intervention / Treatment
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* Diagnostic Test: BD Veritor At-Home
* Diagnostic Test: BD Veritor Professional


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BD Veritor<br>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<br>* BD Veritor At-Home rapid self testing<br>Diagnostic Test: BD Veritor Professional<br>* BD Veritor Professional rapid test<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS COV 2, Influenza