INTENDED USE

This product is used for in vitro qualitative detection of novel coronavirus (2019-nCoV) antigens in human throat swabs and nasal swabs.

This product is limited to medical institutions.

The novel coronavirus belongs to the β genus. Novel coronavirus pneumonia is an acute respiratory infectious disease, and the population is generally susceptible. The main source of infection is the patients who has been infected by the novel coronavirus, and the asymptomatic carrier may also be the source of infection. Based on the current epidemiological investigation, the incubation period is 1-14 days, mostly 3-7 days. The main manifestations are fever, dry cough, and fatigue. A small number of patients are accompanied by nasal congestion, runny nose, sore throat, myalgia and diarrhea.

PRINCIPLE

The novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) uses immunochromatography technology and adopts the principle of double antibody sandwich method for detection. During the chromatography, the novel coronavirus (2019-nCoV) antigen in the sample reacts with the colloidal gold-labeled novel coronavirus (2019-nCoV) antibody 1 to form a complex, which moves forward along the nitrocellulose membrane under the action of chromatography. In the detection area, it combines with the novel coronavirus (2019-nCoV) antibody 2 coated on the nitrocellulose membrane to form a sandwich complex and deposits on the detection line (T line) to form a purple-red band; on the contrary, if the sample does not contain the novel coronavirus ( 2019-nCoV) antigen, the purple-red band will not form on the detection line (T line). Regardless of whether the sample contains the novel coronavirus (2019-nCoV) antigen, the chicken IgY in the gold label pad and the goat anti-chicken IgY on the detection line (C line) will form a specific binding, which forms a purple-red band at the position of the detection line (C line).