Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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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

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SARS-CoV-2 COVID-19 RSV Influenza

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptomatic Cohort

Subjects displaying signs and/or symptoms of respiratory tract infections

Credo POCT Device

Intervention Type DEVICE

Testing Credo's POCT device for respiratory viruses detection.

Interventions

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Credo POCT Device

Testing Credo's POCT device for respiratory viruses detection.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No