Protocol of the Luebeck longitudinal investigation of SARS-CoV-2 infection (ELISA) study - a prospective population-based cohort study

Alexander Balck; Bandik Föh; Max Borsche; Johann Rahmöller; Eva-Juliane Vollstedt; Frederike Waldeck; Nadja Käding; Christoph Twesten; Alexander Mischnik; Gabriele Gillessen-Kaesbach; Marc Ehlers; Christian Sina; Stefan Taube; Hauke Busch; Jan Rupp; Alexander Katalinic; Christine Klein

doi:10.1186/s12889-022-13666-z

Protocol of the Luebeck longitudinal investigation of SARS-CoV-2 infection (ELISA) study - a prospective population-based cohort study

BMC Public Health. 2022 Jul 7;22(1):1305. doi: 10.1186/s12889-022-13666-z.

Authors

Alexander Balck^{1

2}, Bandik Föh^{3

4}, Max Borsche^{1

2}, Johann Rahmöller^{3

5}, Eva-Juliane Vollstedt¹, Frederike Waldeck⁶, Nadja Käding⁶, Christoph Twesten⁷, Alexander Mischnik⁸, Gabriele Gillessen-Kaesbach⁹, Marc Ehlers³, Christian Sina³, Stefan Taube¹⁰, Hauke Busch¹¹, Jan Rupp⁶, Alexander Katalinic¹², Christine Klein¹³

Affiliations

¹ Institute of Neurogenetics, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.
² Department of Neurology, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.
³ Institute of Nutritional Medicine, University of Lübeck, Lübeck, Germany.
⁴ Department of Medicine I, University Hospital Schleswig-Holstein, Lübeck, Germany.
⁵ Department of Anesthesiology and Intensive Care, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.
⁶ Department of Infectious Diseases and Microbiology, University of Lübeck and University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
⁷ Perfood GmbH, Lübeck, Germany.
⁸ Health Protection Authority, Lübeck, Germany.
⁹ University of Lübeck, Lübeck, Germany.
¹⁰ Institute of Virology and Cell Biology, University of Lübeck, Lübeck, Germany.
¹¹ Lübeck Institute of Experimental Dermatology (LIED), University of Lübeck, Lübeck, Germany.
¹² Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.
¹³ Institute of Neurogenetics, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany. christine.klein@neuro.uni-luebeck.de.

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.

Keywords: Antibodies; COVID-19; Cohort-study; Coronavirus; ELISA; Pandemic; Risk behaviors; Risk factors; Surveillance.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

COVID-19* / diagnosis
COVID-19* / epidemiology
Cohort Studies
Cross-Sectional Studies
Enzyme-Linked Immunosorbent Assay
Follow-Up Studies
Humans
Prospective Studies
Quality of Life
SARS-CoV-2*
Seroepidemiologic Studies

Supplementary concepts

SARS-CoV-2 variants