Influenza A+b & COVID-19 Ag Combo Test Cassette

Short Description:

HImedic COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARS- CoV-2, influenza A and influenza B viral nucleoprotein antigens in nasopha- ryngeal swab from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is intended for the detection and differentiation of SARS-CoV-2, influenza A and influenza B viral nucleoprotein antigens. Antigens are generally detectable in nasopharyngeal specimens during the acute phase of infection. 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.

Negative results do not rule out SARS-CoV-2, influenza A or influenza B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results must be combined with clinical observations, patient history and epidemiological information, and confirmed with a molecular assay, if necessary for patient management.

The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.