COVID-19 Infection
Conditions
Keywords
Sars-CoV-2 infection, ELISA test, lateral flow assay, point of care (POC) assay, saliva based serology
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
Interventions
DIAGNOSTIC_TESTblood 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_TESTfingertip tests for POC assays
performing POC test by taking two blood drops from the fingertip
DIAGNOSTIC_TESTsaliva 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_TESTcollection of swabs
collection of nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation)
Sponsors
ETH Zurich (Switzerland)
Health Department of the Canton of Basel-Stadt
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative method validation (yes/ no) | at baseline | Qualitative method validation: qualitative result of the ELISA (Patient does / does not have immunity) as the gold standard compared to the POC using univariate measures to derive sensitivity and specificity of the POC. |
| Quantitative method validation (antibody concentrations) | at baseline | Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune cell repertoire sequencing | at baseline | Antibody and T cell repertoires and transcriptional profiles of cells will be used to identify potential antibody and T cell clones correlated with COVID-19 protection. |
Countries
Switzerland
Outcome results
None listed