Performance of the Simplexa™ Flu A/B & RSV Direct Kit on respiratory samples collected in saline solution

AbstractBackground: Molecular assays for diagnosis of influenza A, influenza B, and respiratory syncytial virus (RSV) with short turnaround time are of considerable clinical importance. We have evaluated the diagnostic performance of the Simplexa™ Flu A/B & RSV Direct Kit, which has a run time of 60 min, using different types of respiratory samples collected from patients with a suspected respiratory tract infection, including materials not previously evaluated on this kit. Methods: In total, 210 clinical respiratory samples were analyzed using both the Simplexa direct assay and a laboratory-developed assay (LDA). The 210 clinical samples included 99 nasopharyngeal aspirates collected in 0.9% saline, 91 nasopharyngeal swabs in Σ-Virocult transport medium, 9 tracheal secretions, 8 bronchoalveolar lavages (BAL), and 3 other respiratory sample materials. Results: The specificity of the Simplexa assay, using the LDA as gold standard and excluding secondary viral findings, was 100% for all three viruses, where...