IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679

This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor. In order to meet the minimum sample requirements, and to demonstrate performance on a range of viral strains, the prospective collection may be supplemented with banked remnant nasal and/or nasopharyngeal samples.

Inclusion Criteria:Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study.Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and nasal swab collection.Individuals suspected to have respiratory tract infection and a pathogen test is requested by a healthcare provider.Subjects suspected to have respiratory tract infection for ten (10) or fewer days.Exclusion Criteria:Participants meeting the following criterion will be excluded from the study:Suspected to have respiratory tract infection for greater than ten (10) days.