This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.
Description: Product Performance will be assessed based on samples collected in 2015/2016 season (average of 6 months) and archived samples.Measure: Product performance as measured by positive and negative agreement to a predicate Time: Specimen collected during the IFV-RSV season 2015/2016 will be tested within 1 day of enrollment. The Product Performance will be assessed at study completion, an average of 6 months.
There is one SNP
The IFV-RSV Panel is an in vitro PCR-based molecular diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A (including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal swabs (NP) in viral transport media (VTM) in adults, adolescents, and children. --- H275Y ---