SARS-CoV-2NCT06689423
Clinical Evaluation of the VitaSIRO Solo™ Respiratory Assay
An observational study of SARS-CoV-2 and COVID-19, run by Credo Diagnostics Biomedical Pte. Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2, COVID-19, RSV
- What is being tested?
- Credo POCT Device
- Type of treatment
- Medical device
- How many people
- 1,268 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2024to 18 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Subject displaying one or more of the following signs and/or symptoms of a respiratory tract infection:
- Fever
- Cough
- Nasal Congestion
- Shortness of breath
- Difficulty in breathing
Show all 16Show fewer
- Runny nose
- Sore throat
- Muscle pain
- Headache
- Chills
- Nausea
- Diarrhoea
- Vomiting
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Credo Diagnostics Biomedical Pte Ltd. Taiwan Branch
New Taipei City
About this study
Official title: Clinical Performance Evaluation of the VitaSIRO Solo™ SARS-CoV-2/Flu/RSV Assay
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.
Read the 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.
- Conditions
- SARS-CoV-2, COVID-19, RSV, Influenza
- Being tested
- Credo POCT Device
- Keywords
- Respiratory, SARS-CoV-2, COVID-19, Influenza, RSV, POCT
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Credo POCT DeviceDevice
Testing Credo's POCT device for respiratory viruses detection.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic Cohort | Subjects displaying signs and/or symptoms of respiratory tract infections Receives: Device: Credo POCT Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive percent agreement(PPA) and Negative percent agreement (NPA)
Positive percent agreement(PPA) and Negative percent agreement (NPA) between the VitaSIRO solo™ SARS-CoV-2/Flu/RSV and Cepheid Xpert® Xpress CoV-2/Flu/RSV plus assay
Measured: In 7 days after specimen collection
Secondary outcomes (1)
Comparison to SOC testing
Evaluation of Diagnostic Performance Metrics for the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay: Sensitivity, Specificity, PPV, and NPV Using Nasal and Nasopharyngeal Swabs Compared to Standard-of-Care Diagnostics
Measured: In 7 Days after specimen collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Nov 2024
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Credo Diagnostics Biomedical Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689423
- Sponsor's protocol ID
- B-AO-11-011
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Truwit JD, Fleming K, Nanchal RS. Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation. Respir Care. 2025 Aug;70(8):937-945. doi: 10.1089/respcare.12586. Epub 2025 Feb 24.
PubMed 40028879
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of the VitaSIRO Solo™ SARS-CoV-2/Flu/RSV Assay
- ClinicalTrials.gov ID
- NCT06689423
- Acronym / sponsor ID
- B-AO-11-011
- Conditions
- SARS-CoV-2, COVID-19, RSV, Influenza
- Keywords
- Respiratory, SARS-CoV-2, COVID-19, Influenza, RSV, POCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,268 participants (actual)
- Lead sponsor
- Credo Diagnostics Biomedical Pte. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Medical College of Wisconsin
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Cohort | – | Device: Credo POCT DeviceSubjects displaying signs and/or symptoms of respiratory tract infections |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- Subject displaying one or more of the following signs and/or symptoms of a respiratory tract infection:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Credo POCT DeviceTesting Credo's POCT device for respiratory viruses detection. | Device | Symptomatic Cohort |
Primary outcome
Positive percent agreement(PPA) and Negative percent agreement (NPA)
Time frame: In 7 days after specimen collection
Positive percent agreement(PPA) and Negative percent agreement (NPA) between the VitaSIRO solo™ SARS-CoV-2/Flu/RSV and Cepheid Xpert® Xpress CoV-2/Flu/RSV plus assay
1 secondary outcome
Comparison to SOC testing
Time frame: In 7 Days after specimen collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 40028879Truwit JD, Fleming K, Nanchal RS. Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation. Respir Care. 2025 Aug;70(8):937-945. doi: 10.1089/respcare.12586. Epub 2025 Feb 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and COVID-19, run by Credo Diagnostics Biomedical Pte. Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive percent agreement(PPA) and Negative percent agreement (NPA) (time frame: In 7 days after specimen collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06689423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.