Trials / Completed
CompletedNCT06689423
Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay
Clinical Performance Evaluation of the VitaSIRO Solo™ SARS-CoV-2/Flu/RSV Assay
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,268 (actual)
- Sponsor
- Credo Diagnostics Biomedical Pte. Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical trial is to demonstrate the clinical performance of the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay in detecting SARS-CoV-2, Flu A, Flu B and RSV in symptomatic population. The primary aim is to determine the PPA/NPA against a comparator assay. The secondary aim is to determine the diagnostic sensitivity, specificity, PPV and NPV against the standard-of-care test. Each subjects will be asked to provide both nasal swab (NS) and nasopharyngeal swab (NPS) for testing purposes.
Detailed description
The study is designed as a multisite, observational, prospective study. Subjects will be prospectively recruited from the target population, specifically individuals displaying signs and/or symptoms of respiratory tract infections. Consent for participation will be obtained prior to any eligibility confirmation or sample collection. Subsequently, both nasal swab (NS) and nasopharyngeal swab (NPS) specimens will be collected from each subject. These specimens will be tested using both the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay and the Cepheid Xpert Xpress CoV-2/Flu/RSV plus assay (comparator) to determine the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). Subjects will be recruited across up to 20 sites, targeting the following intended user groups: Trained laboratory professionals in a central laboratory setting Trained healthcare practitioners in a point-of-care (POC) setting under CLIA moderate and high complexity. If a standard-of-care (SOC) diagnosis is available, the sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) will also be calculated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Credo POCT Device | Testing Credo's POCT device for respiratory viruses detection. |
Timeline
- Start date
- 2024-11-01
- Primary completion
- 2025-12-18
- Completion
- 2025-12-18
- First posted
- 2024-11-14
- Last updated
- 2026-03-18
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT06689423. Inclusion in this directory is not an endorsement.