Covid19, SARS CoV-2
Conditions
Brief summary
This study is being conducted to assess the performance of the BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2, used in serial testing, in identification of infectious, asymptomatic individuals. This information may be used to inform development of an effective testing strategy by policy makers.
Detailed description
This multi-center, prospective, observational, diagnostic evaluation study is designed to assess the performance of the BD Veritor System in the detection of SARS-CoV-2 in asymptomatic individuals compared to viral culture and a commercially available RT-PCR assay over multiple testing time points. The study will enroll a minimum of 150 asymptomatic, adult participants who test positive for SARS-CoV-2 during community/traveler screening procedures.
Interventions
DIAGNOSTIC_TESTBD Veritor Plus System for Rapid Detection of SARS CoV-2
Nasal Sawb for the conduct of the Veritor Antigen Test
DIAGNOSTIC_TESTrt-PCR
Nasopharyngeal Swab for the conduct of a rt-PCR
DIAGNOSTIC_TESTviral culture
Nasopharyngeal Swab for the conduct of viral culture
Sponsors
Becton, Dickinson and Company
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥21 years of age at the time of informed consent 2. Has a positive screening test for SARS-CoV-2 by RT-PCR 3. Is asymptomatic for COVID-19 on the day of their positive screening test (may have symptoms on the actual day of study enrollment) 4. Is expected to remain at the study site for the full 6-day study period 5. Willing and able to complete all study required procedures 6. Provision of signed and dated informed consent form
Exclusion criteria
1. History of frequent or difficult to control nosebleeds within the 14 days prior to study participation 2. If, at the discretion of the Investigator, involvement in the study is likely to jeopardize the subject's health or their current or future medical treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared viral culture, over multiple collection time points | 6 days | * Assay results: Positive percent agreement (PPA) * Assay results: Negative percent agreement (NPA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared to a commercially available RT-PCR asay, over multiple collection time points | 6 days | * Assay results: Positive percent agreement (PPA) * Assay results: Negative percent agreement (NPA) |
| Assess the performance a commercially available RT-PCR assay compared to viral culture, over multiple test time points | 6 days | * Assay results: Positive percent agreement (PPA) * Assay results: Negative percent agreement (NPA) |
Countries
Singapore
Outcome results
None listed