Official Title
COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses (SERO-BL-COVID-19)
Brief Summary

The study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.

Detailed Description

This study is to analyse the antibody response in the blood and saliva of people with a known
COVID-19 infection in the canton of Baselland.

The study aims to validate strategies to measure antibody levels with minimal intervention
and to explore the antibody response and technical capacity for said measurement. The study
will collect the minimally necessary samples to deduce a strategy for serum or saliva
surveillance of the population of the canton Baselland. To achieve this, the study is
designed to address the following points:

- determine specificity, sensitivity and general utility of point of care (POC) and ELISA
tests to deduce a strategy for serum surveillance of the population of the canton
Baselland

- especially validate different POC kits in regard of their use for continuous
surveillance

- gain an understanding of seroconversion and antibody levels of patients and survivors

- gain an understanding of the individual antibody and T-cell repertoire of patients and
survivors

- study whether patterns of convergent antibody evolution is generated in the surviving
population or whether the diseases survivors generated an antibody pool recognizing a
specific epitope

- develop the technology to correlate blood antibody levels with levels detected in the
saliva

- develop high throughput technologies for the precise detection of immune cell Repertoire
and binding epitopes

Completed
Covid-19 Infection

Diagnostic Test: blood draw

2x 10ml of blood, one vial to obtain the antibodies and one vial in ethylenediaminetetraacetic acid (EDTA) (or citrate-treated) to obtain peripheral blood mononuclear cells (PBMCs)

Diagnostic Test: fingertip tests for POC assays

performing POC test by taking two blood drops from the fingertip

Diagnostic Test: saliva collection

saliva collection: the patient delivers saliva into an adsorbent filter, which is placed in the Salivette tube, centrifuged at 1,600x g for 15 min at 4°C to remove cells and debris. Native supernatant is used for testing.

Diagnostic Test: collection of swabs

collection of nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation)

Eligibility Criteria

Inclusion Criteria:

- tested positive for COVID-19 in Baselland

- tested negative for COVID-19 in Baselland. Specifically, needed to show symptoms to be
able to deduce cross reactivities.

Exclusion Criteria:

- continuous steroid therapy / chemotherapy / immunsuppressiva

- subject is treated for cancer

- severe autoimmune disease

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Switzerland
Locations

Department of Health, Economics and Health Directorate Canton Basel-Land
Liestal, Switzerland

Miodrag Savic, Dr. med., Principal Investigator
Department of Health, Economics and Health Directorate Canton Basel-Land

University Hospital, Basel, Switzerland
NCT Number
Keywords
SARS-CoV-2 infection
ELISA test
lateral flow assay
point of care (POC) assay
saliva based serology
MeSH Terms
COVID-19