BD Veritor™ At-Home and BD Veritor™ Professional

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Upper Respiratory Infection

Treatments: Diagnostic Test: BD Veritor At-Home; Diagnostic Test: BD Veritor Professional

Study type: Observational

Funder types: Industry

Identifiers

NCT05352581

IDS-VERTPPGEN2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,146 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,146 participants in 1 patient group

BD Veritor

Description:

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)

Treatment:

Diagnostic Test: BD Veritor At-Home

Diagnostic Test: BD Veritor Professional