The purpose of this clinical trial is to demonstrate the clinical performance of theVitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay in detecting SARS-CoV-2, Flu A, Flu B and RSV insymptomatic population. The primary aim is to determine the PPA/NPA against a comparatorassay. The secondary aim is to determine the diagnostic sensitivity, specificity, PPV andNPV against the standard-of-care test. Each subjects will be asked to provide both nasalswab (NS) and nasopharyngeal swab (NPS) for testing purposes.
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.
Device: Credo POCT Device
Testing Credo's POCT device for respiratory viruses detection.
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.
Credo Diagnostics Biomedical Pte Ltd. Taiwan Branch
New Taipei City, Taiwan
Investigator: Jane HUANG
Contact: +886 921026027
jane.huang@credodxbiomed.com
Jane HUANG
+886 921026027
jane.huang@credodxbiomed.com
Not Provided