SEROBL-COVID19: COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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:
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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
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especially validate different POC kits in regard of their use for continuous surveillance
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gain an understanding of seroconversion and antibody levels of patients and survivors
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gain an understanding of the individual antibody and T-cell repertoire of patients and survivors
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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
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develop the technology to correlate blood antibody levels with levels detected in the saliva
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develop high throughput technologies for the precise detection of immune cell Repertoire and binding epitopes
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 Disease survivors with a positive polymerase chain reaction (PCR) test > 12days (d) ago and no symptoms (~250 participants). Cohort 1 & 2 are supposed to have an antibody response to different levels and should provide ability to deduce the detection limit, and estimate the true positive and false negative rates of both ELISA and POC assays. |
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.
|
| Cohort 2 Disease survivors with a positive PCR test 7 - 12d ago and no symptoms (~100 participants). Cohort 1 & 2 are supposed to have an antibody response to different levels and should provide ability to deduce the detection limit, and estimate the true positive and false negative rates of both ELISA and POC assays. |
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.
|
| Cohort 3 Subjects with PCR negative test > 5d (~100 participants). Cohort 3 & 4 are the control groups. They are supposed to not have an antibody response for COVID-19 and should therefore help estimate the true negative and false positive rates. |
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)
|
| Cohort 4 Anonymised blood sera from the "Serumbank" at the Kantonsspital Basel-Land (KSBL) taken during last years influenza period (~100 participants). Cohort 3 & 4 are the control groups. They are supposed to not have an antibody response for COVID-19 and should therefore help estimate the true negative and false positive rates. |
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)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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tested positive for COVID-19 in Baselland
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tested negative for COVID-19 in Baselland. Specifically, needed to show symptoms to be able to deduce cross reactivities.
Exclusion Criteria:
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continuous steroid therapy / chemotherapy / immunsuppressiva
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subject is treated for cancer
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severe autoimmune disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Health, Economics and Health Directorate Canton Basel-Land | Liestal | Switzerland | 4410 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
- ETH Zurich (Switzerland)
- Health Department of the Canton of Basel-Stadt
Investigators
- Principal Investigator: Miodrag Savic, Dr. med., Department of Health, Economics and Health Directorate Canton Basel-Land
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BASEC Project-ID 2020-00816