1. Protocol of the Luebeck longitudinal investigation of SARS-CoV-2 infection (ELISA) study - a prospective population-based cohort study.
- Author
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Balck A, Föh B, Borsche M, Rahmöller J, Vollstedt EJ, Waldeck F, Käding N, Twesten C, Mischnik A, Gillessen-Kaesbach G, Ehlers M, Sina C, Taube S, Busch H, Rupp J, Katalinic A, and Klein C
- Subjects
- Cohort Studies, Cross-Sectional Studies, Enzyme-Linked Immunosorbent Assay, Follow-Up Studies, Humans, Prospective Studies, Quality of Life, Seroepidemiologic Studies, COVID-19 diagnosis, COVID-19 epidemiology, SARS-CoV-2
- Abstract
Background: Considering the insufficiently controlled spread of new SARS-CoV-2 variants, partially low vaccination rates, and increased risk of a post-COVID syndrome, well-functioning, targeted intervention measures at local and national levels are urgently needed to contain the SARS-CoV-2 pandemic. Surveillance concepts (cross-sectional, cohorts, clusters) need to be carefully selected to monitor and assess incidence and prevalence at the population level. A critical methodological gap for identifying specific risks/dynamics for SARS-Cov-2 transmission and post-COVID-19-syndrome includes repetitive testing for past or present infection of a defined cohort with simultaneous assessment of symptoms, behavior, risk, and protective factors, as well as quality of life., Methods: The ELISA-Study is a longitudinal, prospective surveillance study with a cohort approach launched in Luebeck in April 2020. The first part comprised regular PCR testing, antibody measurements, and a recurrent App-based questionnaire for a population-based cohort of 3000 inhabitants of Luebeck. The follow-up study protocol includes self-testing for antibodies and PCR testing for a subset of the participants, focusing on studying immunity after vaccination and/or infection and post-COVID-19 symptoms., Discussion: The ELISA cohort and our follow-up study protocol will enable us to study the effects of a sharp increase of SARS-CoV-2 infections on seroprevalence of Anti-SARS-CoV-2 antibodies, post-COVID-19-symptoms, and possible medical, occupational, and behavioral risk factors. We will be able to monitor the pandemic continuously and discover potential sequelae of an infection long-term. Further examinations can be readily set up on an ad-hoc basis in the future. Our study protocol can be adapted to other regions and settings and is transferable to other infectious diseases., Trial Registration: DRKS.de, German Clinical Trials Register (DRKS), Identifier: DRKS00023418 , Registered on 28 October 2020., (© 2022. The Author(s).)
- Published
- 2022
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