PRODUCT NAME
COVID-19 Antigen Detection Kit

INTENDED USE
This product is suitable for the qualitative detection of novel coronavirus in nasopharyngeal swab or saliva samples. It provides an aid in the diagnosis of infection with novel coronavirus.

SUMMARY
The novel coronaviruses belong to the fl genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic virus carriers can also be infectious sources. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are also found in some cases.

PRINCIPLE
The COV1D-I9 Antigen Detection Kit is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibody against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates absorbed in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen is present in the sample, the complex of the anti-SARS-CoV-2 conjugate and the virus will be captured by the specific anti-SARS-CoV-2 monoclonal antibodies coated on the test line region (T). Absence of the T line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking effect has occurred.

COMPOSITION
1.    Test Card
2.    Sample Extraction Tube
3.    Tube Cap
4.    Sampling Swab
5.    Paper Cup
6.    Saliva Dropper