NCT05352581

BD Veritor™ At-Home and BD Veritor™ Professional

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,146 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Upper Respiratory Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	BD Veritor At-Home	BD Veritor At-Home rapid self testing
DIAGNOSTIC_TEST	BD Veritor Professional	BD Veritor Professional rapid test

Timeline

• Start date: 2022-07-21
• Primary completion: 2023-03-09
• Completion: 2023-04-14
• First posted: 2022-04-29
• Last updated: 2023-06-07

Locations

17 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated device study