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Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay

NCT06689423 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1268

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Credo POCT Device

Testing Credo's POCT device for respiratory viruses detection.

Sponsors & Collaborators

  • Medical College of Wisconsin

    collaborator OTHER

  • Credo Diagnostics Biomedical Pte. Ltd.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-12-18
Completion
2025-12-18

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06689423 on ClinicalTrials.gov