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Clinical Evaluation of the VitaSIRO Solo™ Respiratory 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.
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