Immune Status SARS-CoV-2 in a Sample of a Tertiary Eye Health Centre

Study Overview
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Brief Summary
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A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The protocol included a rapid test and several ELISA tests within a defined cohort of healthcare workers.

Detailed Description
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In the current pandemic, the assessment of actual COVID-19 infections plays an important role in the assessment of the risk and progress of the epidemic. Shortly, more and more rapid tests will be available, the aim of which is to be able to obtain a good overview of the immune status of corresponding samples in a timely manner. Employees in the health sector are faced with additional challenges, not only due to the tightened hygiene regulations. The concern about infecting other people and/or exposing oneself to a relevant health risk is of great importance. A moderate to high transmission risk can be assumed for ophthalmology. In view of older patients and sometimes unavoidable proximity, targeted and reliable diagnostics can offer the potential to reduce the risk potential for the current situation by determining antibodies. A rapid diagnosis is not yet available outside of clinical studies, especially since deficits in specificity (contact with other coronaviruses) are to be expected. Studies on the serological reaction are not yet available for longer observation periods, but it can be assumed that positive direct detection of IgG (Anti Sars-CV-2-ELISA; Euroimmun) is available at the latest 3 weeks after the onset of symptoms. Without larger and representative analyses, it is currently unclear whether seroconversion is associated with permanent immunity or a lack of it leads to a possible susceptibility to reinfection. A combined test procedure is therefore to be offered to employees within the framework of a random sample. The query of anamnestic parameters allows the assignment to different groups (CC: past COVID infection, PC: possible infection, N: asymptomatic). The primary goal of the planned study is to provide a first preliminary evaluation of the tests used in the current context.

Official Title
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Immune Status: Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Sample of the Eye Department (University Eye Hospital and Research Institute Tübingen)

Conditions
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History of Covid-19, Seroprevalence

Intervention / Treatment
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* Diagnostic Test: Antibody Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Employees of the health facility described voluntary request for testing Exclusion Criteria: - None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthcare Worker<br>Staff of the Department of Ophthalmology, University Tuebingen, Germany | Diagnostic Test: Antibody Test<br>* Presence and Titer of Anti-Sars-CoV-2 Antbodies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprevalence | Rate of anti-SARS-CoV-2 Antibodies | through study completion, maximum of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of the test results and questionnaire | Kappa statistics | through study completion, maximum of one year | 
| Positive predictive / negative values of the tests applied |  | through study completion, maximum of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seroprevalence, Covid-19