The COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test is for the qualitative detection of IgG and IgM antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. It is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV-2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests.