SARS-CoV-2 IgM/IgG Antibody Test is a rapid, qualitative, immunochromatographic assay for the detection of IgG and IgM antibodies of coronavirus disease in human serum, plasma or whole blood. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with coronavirus antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies to coronavirus at detectable level, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with anti-human IgM. IgM antibodies to coronavirus, if present in the specimen at detectable level, reacts with the anti-human IgM and the coronavirus antigen-coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line in IgM test line region. Therefore, if the specimen contains IgG antibodies to coronavirus at detectable level, a colored line will appear in IgG test line region.

If the specimen contains IgM antibodies to coronavirus at detectable level, a colored line will appear in IgM test line region. If the specimen does not contain antibodies to coronavirus, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.