INTENDED USE
The 2019-nCOV IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG&IgM antibody of WUHAN New Coronavirus in human whole blood,serum,or plasma as an aid in the diagnosis of 2019-nCOV infections.
SUMMARY
Coronavirus (CoV) belongs to the genus Nestovirus, Coronaviridae,and is divided into three genera:α,β,and γ.The genus α and β are only pathogenic to mammals.The genus γ mainly causes bird infections.CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route. So far, there are 7 types of human coronavirus (HCoV) that cause human respiratory diseases: HCoV-229E,HCoV-OC43,SARS-CoV,HCoV-NL63,HCoV-HKU1,MERS-CoV and new coronaviruses (2019) , Is an important pathogen of human respiratory infections.Among them, the new coronavirus (2019) was discovered due to Wuhan virus pneumonia cases in 2019. The clinical manifestations are systemic symptoms such as fever and fatigue,accompanied by dry cough and dyspnea,etc.,which can rapidly develop into severe pneumonia,respiratory failure, and acute breathing.Distress syndrome, septic shock,multiple organ failure,severe acid-base metabolism disorders,etc. are even life-threatening.
PRINCIPLE
This kit uses immunochromatography.The test card contains:1) colloidal gold-labeled recombinant new coronavirus antigen and quality control antibody gold markers;2) two detection lines (G and M lines) and one quality Control line (C line) of nitrocellulose membrane. The M line is immobilized with a monoclonal anti-human IgM antibody for detecting a new coronavirus IgM antibody;the G line is immobilized with a reagent for detecting a new coronavirus IgG antibody; and the C line is immobilized with a quality control antibody. When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary.If the sample contains an IgM antibody, the antibody will bind to the colloidal gold-labeled new coronavirus antigen. The immune complex will be captured by the anti-human IgM antibody immobilized on the membrane to form a purple-red M line,showing that the new coronavirus IgM antibody is positive. If the sample contains an IgG antibody, the antibody will bind to the colloidal gold-labeled new coronavirus antigen,and the immune complex will be captured by the reagent immobilized on the membrane to form a purple-red G line, indicating that the new coronavirus IgG antibody is positive. If the test lines G and M are not colored,a negative result is displayed.The test card also contains a quality control line C.The fuchsia quality control line C should appear regardless of whether a test line appears.The quality control line is a color band of the quality control antibody immune complex. If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card.
