Hangzhou AllTest Biotech COVID-19 Antigen Rapid Test (Oral Fluid)

The COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS- CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS- CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. 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 do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. For professional in vitro diagnostic use only