Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay

March 16, 2026 updated by: Credo Diagnostics Biomedical Pte. Ltd.

Clinical Performance Evaluation of the VitaSIRO Solo™ SARS-CoV-2/Flu/RSV Assay

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1268

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Credo Diagnostics Biomedical Pte Ltd. Taiwan Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects involved in the study include individuals displaying signs and/or symptoms of respiratory tract infections as per the intended purpose of the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay. There are no specifications for subjects based on age, race, sex or any other demographic. However, demographic information will be collected for each subject.

Description

Inclusion Criteria:

  • Subject displaying one or more of the following signs and/or symptoms of a respiratory tract infection:

    1. Fever
    2. Cough
    3. Nasal Congestion
    4. Shortness of breath
    5. Difficulty in breathing
    6. Runny nose
    7. Sore throat
    8. Muscle pain
    9. Headache
    10. Chills
    11. Nausea
    12. Diarrhoea
    13. Vomiting
    14. New loss of taste/smell
  • If age 18 or over, subject is willing and capable of providing written informed consent. If under the age of 18, parent or legal guardian is willing to and capable of providing consent/assent. Assent should be obtained from minor subjects of appropriate intellectual age as defined by the IRB.

Exclusion Criteria:

  • Subject is unable to provide consent and assent (as appropriate) or parental/legal guardian consent permission and assent (as appropriate) cannot be obtained.
  • PI determines that specimen collection represents an unacceptable risk.
  • Subjects who have already been enrolled in the study previously.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic Cohort
Subjects displaying signs and/or symptoms of respiratory tract infections
Device: Credo POCT Device
Testing Credo's POCT device for respiratory viruses detection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive percent agreement(PPA) and Negative percent agreement (NPA)
Time Frame: In 7 days after specimen collection
Positive percent agreement(PPA) and Negative percent agreement (NPA) between the VitaSIRO solo™ SARS-CoV-2/Flu/RSV and Cepheid Xpert® Xpress CoV-2/Flu/RSV plus assay
In 7 days after specimen collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison to SOC testing
Time Frame: In 7 Days after specimen collection
Evaluation of Diagnostic Performance Metrics for the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay: Sensitivity, Specificity, PPV, and NPV Using Nasal and Nasopharyngeal Swabs Compared to Standard-of-Care Diagnostics
In 7 Days after specimen collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Credo Diagnostics Biomedical Pte. Ltd.

Collaborators

Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

December 18, 2025

Study Completion (Actual)

December 18, 2025

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-AO-11-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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