HIMEDIC COVID-19 Antigen Rapid Test Kit (SALIVA)

Short Description:

HImedic COVID-19 Antigen Rapid Test Cassette(Saliva) is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in saliva from individuals who are suspected of COVID-19 by their healthcare provider.

Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in saliva 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. The agent detected may not be the definite cause of disease.

Negative results do not rule out SARS-CoV-2 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, and confirmed with a molecular assay, if necessary for patient management.

The COVID-19 Antigen Rapid Test Cassette(Saliva) is intended for use by medical professionals or trained operators who are proficient in performing non-laboratory environment that meets the requirements specified in the instructions for use and local regulation.