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Capturing Infectious COVID-19 Asymptomatic Cases in Singapore

Withdrawn
Conditions
SARS CoV-2
Covid19
Interventions
Diagnostic Test: BD Veritor Plus System for Rapid Detection of SARS CoV-2
Diagnostic Test: rt-PCR
Diagnostic Test: viral culture
Registration Number
NCT04812327
Lead Sponsor
Becton, Dickinson and Company
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Prospective Observational Diagnostic Evaluationrt-PCRPotential 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.
Prospective Observational Diagnostic EvaluationBD Veritor Plus System for Rapid Detection of SARS CoV-2Potential 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.
Prospective Observational Diagnostic Evaluationviral culturePotential 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.
Primary Outcome Measures
NameTimeMethod
Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared viral culture, over multiple collection time points6 days

* Assay results: Positive percent agreement (PPA)

* Assay results: Negative percent agreement (NPA)

Secondary Outcome Measures
NameTimeMethod
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 points6 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 points6 days

* Assay results: Positive percent agreement (PPA)

* Assay results: Negative percent agreement (NPA)

Trial Locations

Locations (1)

Changi General Hospital

🇸🇬

Singapore, Singapore

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