Mass evaluation of lateral flow immunoassays for the detection of SARS-CoV-2 antibody responses in immunosuppressed people (MELODY Study)

The MELODY Study aims to assess:1The proportion of immunosuppressed patients who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the demographic, disease, and treatment characteristics that influence antibody status. 2If the detection of antibodies inversely correlates with subsequent risk of SARS-CoV2 infection and/or severity of disease.Building on the successful methodology used in the REACT2 Study (community assessment of SARS-CoV-2 antibody tests), the study will assess self-administered LFIAs in 36,000 patients, who have completed their primary COVID-19 vaccination course. The study will recruit; a) solid organ transplant recipients, b) patients with autoimmune diseases receiving immunosuppression, c) patients with haematological malignancies. The study will utilise the digital web platform and research expertise of Ipsos MORI linked with the patient registries, UK Transplant Registry and National Disease Registration Service (NDRS) at Public Health England, which comprises the National Cancer Registration and Analysis Service (NCRAS) and the National Congenital Anomaly and Rare Disease Registration Service (NCARDRS). Patients will be recruited following a letter of invitation or via an 'opt-in' option on the study web portal. Once consent is registered via the portal, a LFIA kit will be sent to the participant together with instructions to use. Participants will be required to fill in a brief questionnaire and to upload the results of their tests, together with a photograph of the test using a mobile phone, if possible. Once all the data is returned, Ipsos MORI will collate and send the data back to the registries for analysis. The registries will subsequently capture all RT-qPCR proven infection episodes and outcomes over the course of the 6 month study period, and compare outcomes by antibody status.