To evaluate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the on the NeuMoDx™ 288 and 96 Molecular Systems, collectively referred to as NeuMoDx Systems. The results of this study will be used to support regulatory registration and product release in the US, Europe and other markets.
To demonstrate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the NeuMoDx Systems by determining clinical sensitivity and specificity of the Assay.