The SARS-CoV-2/Human Influenza Virus A&B (Flu A&B) Antigen Test Kit (Colloidal Gold) is a lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of nucleocapsid protein antigens from SARS-CoV-2, influenza type A and influenza type B in the same time directly from nasal/nasopharyngeal (NS/NP) swab, oropharyngeal (OP) swab and saliva specimens from patients with signs and symptoms of respiratory viral infection. The SARS-CoV-2/Human Influenza Virus A&B (Flu A&B) Antigen Test Kit (Colloidal Gold) is an aid in the diagnosis of patients with suspected SARS-CoV-2 or influenza infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the SARS-CoV-2/Human Influenza Virus A&B (Flu A&B) Antigen Test Kit (Colloidal Gold) should not be used as the sole basis fordiagnosis.