Evaluation of Simplexa Flu A/B & RSV for Direct Detection of Influenza Viruses (A and B) and Respiratory Syncytial Virus in Patient Clinical Samples

We evaluated the performance of the Simplexa Flu A/B & RSV kit on 170 prospective respiratory samples using a modified protocol, supplied by the manufacturer, that eliminates the RNA extraction step. Overall, compared against our laboratory-developed assay, the assay's sensitivity, specificity, and positive and negative predictive values were 95.1%, 99.6%, 98.7%, and 98.6%, respectively.