Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay

Launched by CREDO DIAGNOSTICS BIOMEDICAL PTE. LTD. · Nov 13, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new test called the VitaSIRO Solo™ Respiratory Assay, which is designed to detect viruses that cause respiratory infections, including COVID-19, influenza (the flu), and RSV (respiratory syncytial virus). The main goal is to see how well this new test works compared to existing tests, particularly in people who are showing symptoms of a respiratory infection, like a cough, fever, or sore throat. Participants will need to provide two types of samples—a nasal swab and a nasopharyngeal swab (which is taken from the back of the nose)—to help with this evaluation.

To be eligible for the study, participants must be experiencing symptoms typical of a respiratory infection and, if they are 18 or older, they must be able to give their consent to participate. For those under 18, a parent or guardian will need to provide consent. It's important to note that this trial is not yet recruiting participants, so no one can join at this time. If someone has already participated in this study before, they will not be able to join again. Overall, this trial aims to improve how we detect these respiratory viruses, helping to ensure better care for patients in the future.

Gender

ALL

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.