GMate COVID-19 Ag 5 Minute Saliva Test

Intended Use

The Gmate® COVID-19 Ag Saliva is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from SARS-CoV-2 virus in human saliva from individuals who are suspected of COVID -19 by their healthcare provider within the first five days of the onset of symptoms. Results are for the identification of SARS-CoV-2 nucleocapsid antigen.
Antigen is generally detectable in human saliva samples 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 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 with 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.

Principle
According to the gold immunochromatographic test principle, double antibody sandwich method is used to detect SARS-CoV-2 antigen in the samples. When the antigen is contained in the sample, the antigen binds with the corresponding gold labeled monoclonal antibody 1 and the coated monoclonal antibody 2 at the test line to form a compound and then condenses into a red band, indicating a positive result. When the sample does not contain antigen, complex cannot be formed at the test line, and no red band appears, indicating negative result.
Regardless of whether the SARS-CoV-2 antigen is contained in the sample, the gold labeled antibody will bind with the coated antibody at the C line to form a complex and develop color (C line).