SARS-CoV-2 Human Influenza Virus A&B(Flu A&B)Antigen Test Kit ( Colloidal Gold )

Application

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 for diagnosis. The SARS-CoV-2/Human Influenza Virus A&B(Flu A&B)Antigen Test Kit(Colloidal Gold) is intended to aid in the rapid differential diagnosis of influenza type A and type B and SARS-CoV-2 viral infections, but does not differentiate between SARS-CoV and

SARS-CoV-2, and is not intend for detection of influenza type C virus. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule

out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive and confirmed by viral culture or a molecular assay. Negative results do not rule out COVID-19 and influenza virus infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be

considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The SARS-CoV-2/Human Influenza Virus A&B(Flu A&B)Antigen Test Kit(Colloidal Gold) is intended for use by trained clinical

laboratory personnel and individuals trained in point of care settings. For prescription use only. For in vitro diagnostic use only.

Product information