Respiratory Viral Infection Clinical Trial
Official title:
Clinical Evaluation of SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics
This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1).
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | February 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - The sample is derived from an individual who has the ability to provide consent or from a legally acceptable representative, parent(s), or legal guardian and have consented for their sample and demographic information to be taken - The sample is a nasopharyngeal swab - The sample is collected in universal transport media (UTM) or viral transport media (VTM), using FDA approved swabs - The sample is collected from an individual who has a presumptive diagnosis or is presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea, sore throat, fever, headache, myalgia) or is suspected to be asymptomatic. Exclusion Criteria: - Sample does not meet acceptable specimen criteria in that is not a nasopharyngeal swab - The sample is collected using swabs with wood shafts or other materials known to inhibit growth of influenza viruses |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AusDiagnostics Pty Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with positive samples as evaluated by the AusDiagnostics SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel and the BioFire Respiratory Panel 2.1. | The study will be considered to have reached its primary endpoint when performance data from 50 positive samples for each panel target has been collected and evaluated for precision and concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1). | 6 months |
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