CovidImmunEye: Immune Status SARS-CoV-2 in a Sample of a Tertiary Eye Health Centre
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthcare Worker Staff of the Department of Ophthalmology, University Tuebingen, Germany |
Diagnostic Test: Antibody Test
Presence and Titer of Anti-Sars-CoV-2 Antbodies
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Outcome Measures
Primary Outcome Measures
- Seroprevalence [through study completion, maximum of one year]
Rate of anti-SARS-CoV-2 Antibodies
Secondary Outcome Measures
- Agreement of the test results and questionnaire [through study completion, maximum of one year]
Kappa statistics
- Positive predictive / negative values of the tests applied [through study completion, maximum of one year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Employees of the health facility described
-
voluntary request for testing
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Tuebingen | Tuebingen | BW | Germany | 72076 |
Sponsors and Collaborators
- University Hospital Tuebingen
- Institute of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 292/2020BO2