Description
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INTENDED USE
This product is suitable for the qualitative detection of a novel coronavirus in Sputum/Throat Swab/Stool samples. It provides an aid in the diagnosis of
infection with the novel coronavirus.
SUMMARY
The novel coronaviruses belong to the β 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 infected people can also be an infectious source. 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 found in a few cases.
PRINCIPLE
The COVID-19 Antigen Detection Kit is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in a throat swab. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, an absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies 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 dried in the reagent pad are dissolved and migrate along with the sample. If the SARS-CoV-2 antigen presents in the sample, a complex formed between the anti-SARS-2 conjugate and the virus will be captured by the specific anti-SARS-2 monoclonal antibodies coated on the test line region (T). The 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 has occurred.
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