INTENDEDUSE:2019-nCoV IgG/IgM Antibody Test is an immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serumorplasma sample.Thetestistobeusedasanaidinthediagnosisofcoronavirusinfectiondisease (2019-nCov),whichiscausedbySARS-CoV-2. This test provides only a preliminary test result. Any reactive specimen with the 2019-nCoV IgG/IgM test must be confirmed with alternative testing method(s) and clinical findings. INTRODUCTION: Coronaviruses are enveloped RNAviruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Seven coronavirus species are known to cause human disease. Four viruses - 229E, OC43, NL63, and HKU1 - are prevalent and typically cause common cold symptoms in immunocompetent individuals.4 The three other strains - severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019 Novel Coronavirus (2019-nCoV) - are zoonotic in origin and have been linked to sometimes fatal illness. IgG and IgM antibodies to 2019 Novel Coronavirus can be detected with 2-3 weeks after exposure. IgG remains positive, but the antibody level dropsovertime.