INTENDED USE
The COVID-19 Antigen Rapid Test Device (Colloidal Gold) is a rapid visual immunoassay for the qualitative, presumptive detection of COVID-19 Antigens from oropharyngeal swabs and nasopharyngeal swab specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute COVID-19 virus infection.
PRINCIPLE
The COVID-19 Antigen Rapid Test Device (Colloidal Gold) detects COVID-19 antigens through visual interpretation of color development on the strip. COVID-19 antibodies are immobilized on the test region of the membrane respectively. During testing, the extracted specimen reacts with anti- COVID-19 antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient COVID-19 antigens in the specimen, a colored band will form at the according to test region of the membrane. The presence of a colored band in the test region indicates a positive result for the particular viral antigens, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.