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Study was cancelled prior enrollment due to business decision.
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This study is being conducted to assess the performance of the BD Veritorâ„¢ 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Observational Diagnostic Evaluation | Potential participants will be recruited at study sites where they are admitted/held for COVID-19 isolation. On the first day of isolation (ideally on the day they first test positive for SARS-CoV-2), potential participants will be asked to participate in the study. After consent (Study Day 0), two nasopharyngeal swabs (NP swabs) and one nasal swab will be collected. One NP swab will be tested via viral culture and the other nasal swab will be tested by RT-PCR for SARS-CoV-2. The nasal swab will be tested on the BD Veritor System. Specimen collection and testing will be repeated every 2 days for 6 days (Study Day 2, Day 4, and Day 6) or until the RT-PCR Ct value is >30, whichever comes first. Participants will be monitored for symptoms of COVID-19 throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD Veritor Plus System for Rapid Detection of SARS CoV-2 | Diagnostic Test | Nasal Sawb for the conduct of the Veritor Antigen Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Assess the performance a commercially available RT-PCR assay compared to viral culture, over multiple test time points |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited at study sites from individuals admitted for SARS-CoV-2 isolation. Once enrolled, participants may be transferred to a different care unit, or units, throughout their time in the study depending on their medical needs.
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| Name | Affiliation | Role |
|---|---|---|
| Yen Seow Tan, MD | Hospital Employee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | Singapore |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000087123 | COVID-19 Nucleic Acid Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| rt-PCR | Diagnostic Test | Nasopharyngeal Swab for the conduct of a rt-PCR |
|
| viral culture | Diagnostic Test | Nasopharyngeal Swab for the conduct of viral culture |
|
|
| 6 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 | Investigative Techniques |