Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay

NCT06689423 | Completed

• 1 other identifier: B-AO-11-011
• Study Type: observational
• Target: 1,268
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19; RSV; Influenza; SARS-CoV-2

Keywords

Respiratory; SARS-CoV-2; COVID-19; Influenza; RSV; POCT

Outcome Measures

Primary Outcomes (1)

• Positive percent agreement(PPA) and Negative percent agreement (NPA)

  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 Outcomes (1)

• Comparison to SOC testing

  In 7 Days after specimen collection

Study Arms (1)

Symptomatic Cohort

Subjects displaying signs and/or symptoms of respiratory tract infections

Device: Credo POCT Device

Interventions

Credo POCT Device DEVICE

Testing Credo's POCT device for respiratory viruses detection.

Symptomatic Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject displaying one or more of the following signs and/or symptoms of a respiratory tract infection:
• Fever
• Cough
• Nasal Congestion
• Shortness of breath
• Difficulty in breathing
• Runny nose
• Sore throat
• Muscle pain
• Headache
• Chills
• Nausea
• Diarrhoea
• Vomiting
• New loss of taste/smell

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: collaborator
• Credo Diagnostics Biomedical Pte. Ltd.: lead

Study Sites (1)

Credo Diagnostics Biomedical Pte Ltd. Taiwan Branch

New Taipei City, Taiwan

Location

Related Publications (1)

• Truwit JD, Fleming K, Nanchal RS. Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation. Respir Care. 2025 Aug;70(8):937-945. doi: 10.1089/respcare.12586. Epub 2025 Feb 24.

  PMID: 40028879 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Leftover nasal swab (NS) and nasopharyngeal swab (NPS) specimens will be frozen and shipped back to sponsor for storage which might be used for future assay development.

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 14, 2024
• Study Start: November 1, 2024
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: March 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)