This is a preliminary screening test kit. The 2019-nCoV IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–2019-nCoV virus and IgM anti-2019-nCoV virus in human whole blood, serum or plasma. It is intended for self testing and as a screening test and as an aid in the diagnosis of infection with 2019-nCoV viruses. Any reactive specimen with the 2019-nCoV IgG/IgM Rapid Test must be confirmed with alternative testing method(s). This product is only sold to registered health care professionals.