Upper Respiratory Infection
Conditions
Keywords
SARS COV 2, Influenza
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.
Interventions
DIAGNOSTIC_TESTBD Veritor At-Home
BD Veritor At-Home rapid self testing
DIAGNOSTIC_TESTBD Veritor Professional
BD Veritor Professional rapid test
Sponsors
Becton, Dickinson and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, New Zealand, United States
Outcome results
None listed