INTENDED USE The Diagnostic Kit（Colloidal Gold）for IgG/IgM Antibody to SARS-CoV-2 is a rapid immunoassay for the qualitative detection of antibodies (IgG and IgM) to SARS-CoV-2 virus in Whole Blood /Serum / Plasma.

SUMMARY Coronaviruses belong to the Nidovirales、Coronaviridae and Coronavirus A large class of viruses found widely in nature. The 5 ‘end of the viral group has A methylated cap structure, and the 3′ end has A poly (A) tail,the genome was 27-32kb long. It is the largest known RNA virus with the largest genome.Coronaviruses are divided into three genera: α,β, γ.α,β only the mammal pathogenic, γ is mainly lead to infections of the birds. CoV was also demonstrated to be transmitted mainly through direct contact with secretions or through aerosols and droplets,and it has been shown to be transmitted via the fecal-oral route. Coronaviruses are associated with a variety of diseases in humans and animals, causing diseases of the respiratory, digestive and nervous systems in humans and animals. SARS-CoV-2 belongs to the β coronavirus , which is enveloped, and the particles are round or elliptic, often pleomorphic, with a diameter of 60~140nm, and its genetic characteristics are significantly different from those of SARSr-CoV and MERSr-CoV.The clinical manifestations are fever, fatigue and other systemic symptoms, accompanied by dry cough, dyspnea, etc., which can rapidly develop into severe pneumonia, respiratory failure, acute respiratory distress syndrome, septic shock, multi-organ failure, severe acid-base metabolic disorder, and even life-threatening. SARS-CoV-2 transmission has been identified primarily through respiratory droplets (sneezing, coughing, etc.) and contact transmission (nostril picking, eye rubbing, etc.). The virus is sensitive to ultraviolet light and heat, and can be effectively inactivated by 56℃ for 30 minutes or lipid solvents such as ethyl ether, 75% ethanol, chlorine-containing disinfectant, peroxyacetic acid and chloroform.