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The BD Veritorâ„¢ System is a rapid test that is testing for both COVID-19 and for Influenza This study will try to determine if the BD Veritorâ„¢ 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.
This is a prospective, multi-country, multicenter, comparative study to assess the performance of the BD Veritorâ„¢ At-Home SARS-CoV-2 & Flu A+B test and the BD Veritorâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD Veritor At-Home | Diagnostic Test | BD Veritor At-Home rapid self testing |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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Individuals presenting with symptoms of acute respiratory illness
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTMD Research | Coconut Creek | Florida | 33063 | United States | ||
| CTMD Research |
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Self-collected and clinician collected nasal swabs
| BD Veritor Professional |
| Diagnostic Test |
BD Veritor Professional rapid test |
|
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 |
| Palm Springs |
| Florida |
| 33406 |
| United States |
| DBC Research | Pembroke Pines | Florida | 33029 | United States |
| CTMD Reserarch | Asheville | North Carolina | 28804 | United States |
| Kur Research - AFC Urgent Care | Easley | South Carolina | 29640 | United States |
| Kur Research - AFC Urgent Care | Powdersville | South Carolina | 29611 | United States |
| Kur Research - AFC Urgent Care | Seneca | South Carolina | 29678 | United States |
| Kur Research - Complete Health Partners | Hendersonville | Tennessee | 37075 | United States |
| Kur Research - Complete Health Partners | Nashville | Tennessee | 37209 | United States |
| University of the Sunshine Coast | Sippy Downs | Queensland | 4556 | Australia |
| Southern Clinical Trials - Totara | Auckland | 0600 | New Zealand |
| Optimal Clinical Trials | Auckland | 1010 | New Zealand |
| Southern Clinical Trials - Remuera | Auckland | 1050 | New Zealand |
| Lakeland Clinical Trials - Waikato | Hamilton | 3200 | New Zealand |
| Southern Clinical Trials - Tasman | Nelson | 7011 | New Zealand |
| Silverdale Medical Ltd | Silverdale | 0932 | New Zealand |
| Southern Clinical Trials - Wellington | Upper Hutt | 5018 | New Zealand |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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