Clinical trial NCT06689423: Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay
Official title: Clinical Performance Evaluation of the VitaSIRO Solo™ SARS-CoV-2/Flu/RSV Assay
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: SARS-CoV-2
COVID-19
RSV
Influenza
Keywords: Respiratory
SARS-CoV-2
COVID-19
Influenza
RSV
POCT
Lead sponsor: Credo Diagnostics Biomedical Pte. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Medical College of Wisconsin
First posted: 2024-11-14
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PPA and NPA
timeFrame: In 7 days after specimen collection
Secondary outcomes:
measure: Comparison to SOC testing
timeFrame: In 7 Days after specimen collection
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Credo Diagnostics Biomedical Pte Ltd. Taiwan Branch
Study officials:
References: