COVID-19 Antigen Rapid Test For Rapid Detection of SARS-CoV-2 Antigen
Intended Use (IU): The Jaiyou Medical Essentials Covid-19 Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares swab specimens directly from individuals within 5 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19. This test is authorized for non-prescription home use with self-collected anterior nares swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nares samples directly from individuals aged 2 years or older.
The qualitative detection of SARS CoV-2 antigens in human anterior nasal swabs is performed by double antibody sandwich and nanoparticle immunochromatography. Two highly specific and highly sensitive monoclonal SARS-CoV-2 N antigen antibodies are used for this purpose. During the application of the test, a monoclonal anti-SARS-CoV-2 antibody labeled with colloidal gold is connected to the SARS-CoV-2 antigen in the sample. This reaction complex proceeds chromatographically on the nitrocellulose membrane and is connected to the pre-coated monoclonal anti-SARS-CoV-2 antibody at the detection zone (T) on the test membrane and creates a red reaction line there. If the sample does not contain SARS-CoV-2 antigen, a red color reaction line cannot occur in the T zone. At the same time, a Hühner-IgY-Gold conjugate moves across the membrane during testing and is connected to a pre-coated monoclonal Anti-Hühner-IgY-Antibody in quality control area C, creating a red reaction line there. Regardless of whether the sample to be examined contains the SARS-CoV-2 antigen or not, a red reaction line always occurs in the quality control area (C).
25 x Test cassettes
25 x Specimen collection swabs
25 x Extraction tubes with buffer
1 x Tube stand