Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay
Launched by CREDO DIAGNOSTICS BIOMEDICAL PTE. LTD. · Nov 13, 2024
Trial Information
Current as of July 09, 2025
Not yet recruiting
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.
About Credo Diagnostics Biomedical Pte. Ltd.
Credo Diagnostics Biomedical Pte. Ltd. is a pioneering clinical research organization dedicated to advancing innovative diagnostic solutions and therapeutic interventions in the biomedical field. With a strong emphasis on scientific integrity and patient-centered care, Credo Diagnostics specializes in the design, execution, and management of clinical trials across various therapeutic areas. The company leverages cutting-edge technologies and a robust network of healthcare professionals to deliver high-quality research outcomes, ultimately aiming to enhance patient health and wellbeing through evidence-based medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Taipei City, , Taiwan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported