The Epithod 616 COVID-19 IgM/IgG Test Kit is intended for the semi-quantitative detection of IgM and IgG antibodies to SARS-CoV-2 in whole blood, serum, and plasma from humans with a fast test time of less than two minutes. The gold nanoparticle-based immunoassay test kit is designed for use on the Epithod 616 analyzer which ensures better accuracy and improved sensitivity in analyzing results, and eliminates the risk of undesirable misreading.