Trinity Biotech plc has achieved CE Mark approval and registration for its Covid-19 IgG ELISA antibody test, the Captia SARS-CoV-2 IgG ELISA. Trinity Biotech has launched the test in countries throughout the European Union as well as other countries that recognise the CE Mark designation. This is in addition to launch of the product in the US following submission under the FDAs Emergency Use Authorisation pathway. Test Overview: The test uses a recombinant form of coronavirus spike protein to detect IgG antibodies which are the focus for SARS-CoV-2 vaccine development. The detection of IgG antibodies indicates either past exposure to the virus or the desired immune response following vaccination. Trinity Biotech expects that the antibody test will have a number of uses, including: Assessing if an individual has previously had a SARS-CoV-2 infection and may now be assumed immune. Monitoring individuals in the weeks and months following vaccination, to assess the degree to which their immune system builds an antibody response to the virus. Assisting governments manage the prevalence of Covid-19 immunity in the population. Screening people prior to vaccination to avoid vaccinating individuals who already have a circulating antibody response, particularly in an environment where vaccine supply is constrained. The instrumentation platforms that perform this type of ELISA test are available in virtually all clinical testing laboratories. Trinity Biotech have significant capacity for ELISA manufacture within their current operations and intend to leverage their existing distribution network to optimise the commercialisation of the test kit. Performance Evaluation: A study of healthcare workers using the Trinity Biotech ELISA took place between June and October 2020. In addition to extensive internal testing, eighty-eight participants provided appropriate samples for calculation of the Sensitivity and Specificity at =14 days post Day 0 (date of oro/nasopharyngeal swab). Participants were tested with a PCR test and the Trinity Biotech ELISA.