The Saliva COVID-19 antigen test is designed to detect antigen from the COVID-19 in saliva from patients who are suspected of COVID-19 by their healthcare provider. The One Step COVID-19 N/ S antigen Test Device is a rapid chromatographic immunoassay based on the principle of sandwich antibody and antigen binding. During testing, COVID-19 N/ S antigen, if the Virus antigens present in the saliva specimen it will bind to the antibody carbon nanoparticles conjugates to form a complex. And migrates upward by capillary movement. The complex will then be captured by the immobilized antibody coated at the Test lineregion on the NC membrane. A visible black line will show up in the test line region. The black line will not form in the test lineregion if there is no virus antigen in the sample.

A virus antigen-positive saliva specimen will generate a black line in the test line region because of antigen binding, while a virus antigen-negative saliva specimen or a specimen containing a very low concentration will not generate a line in the test line region.

To serve as a procedural control, a black line will always appear at the control line region (C line), indicating that proper volume of specimen has been added and membrane wicking has occurred.