Description: This kit adopts the sandwich method and the technical principle of colloidal gold immunochromatography to qualitative determine the SARS-CoV-2 antigen. During the test, the sample is dropped into the sample well, and chromatography is performed under the capillary effect. The SARS-CoV-2 antigen in the sample combined with the colloidal goldlabeled SARS-CoV-2 monoclonal antibody I, and then spread to the test area. It is captured by another coated antibody (SARS-CoV-2 monoclonal antibody II), to form a complex and gather in the test area (T line). The quality control area is coated with the goat antimouse antibody, and the colloidal gold-labeled antibody is captured to form a complex and aggregate in the quality control area (C line). If the C line does not show color, it indicates that the result is invalid, and this sample needs to be tested again.

Description: The SARS-CoV-2 Rapid Antigen Test is a lateral fl ow rapid chromatographic immunoassay for the qualitative detection of nucleocapsid antigen to SARS-CoV-2 present in human nasal samples. This test is intended for use as an aid in detection of SARS-CoV-2 infection in individuals suspected of COVID-19 with clinical symptoms onset within 5 days. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in human nasal swab 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. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive, and 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 SARS-CoV-2 Rapid Antigen Test is intended for use in laboratory or POC settings by healthcare professionals, or self-collection under the supervision of a healthcare worke

Description: CE recogniton IVD

Description: Antibody raised against SARS