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.
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 Type
OBSERVATIONAL
Enrollment
1,146
BD Veritor At-Home rapid self testing
BD Veritor Professional rapid test
CTMD Research
Coconut Creek, Florida, United States
CTMD Research
Palm Springs, Florida, United States
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
Time frame: 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
Time frame: Immediately after specimen collection
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
Time frame: 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
Time frame: Within 1 day of first device use
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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