Immunodiagnostic Systems Holdings plc (IDS) announced a new automated SARS-CoV-2 IgM assay (The Test) has achieved CE marking and is expected to be available for sale in the UK, European Union and other countries which accept the CE mark as the basis of regulatory approval in September. The Test, which arises from the partnership between IDS and Technogenetics, is designed to run on the automated IDS-iSYS analyser. For territories which do not accept CE marked products, the requisite regulatory approvals will be required. The presence of IgM antibodies to a virus is generally more short-lived than that of IgG antibodies. Thus, testing both antibody classes often helps the laboratory and clinician differentiate between a recent and an historic infection. During the outbreak of 2003-SARS and 2016-Zika, IgM /IgG antibody detection was used as one of the recommended diagnostic methods. These tests can play a critical role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have been exposed to the SARS-CoV-2 virus and may have developed an immune response. Healthcare authorities have generally requested separate detection of IgM and IgG antibodies, as this can cover a wider period of antibody production, and each isotype may contribute complementary information as to the infection status.