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New Coronavirus 2019-Ncov Nucleic Acid Detection Kit For Human Use

INTENDED USE
The New Coronavirus (COVID-19) 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 COVID-19 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.