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| Name | Class |
|---|---|
| ETH Zurich (Switzerland) | OTHER |
| Health Department of the Canton of Basel-Stadt | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood draw | Diagnostic Test | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative method validation (yes/ no) | 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. | at baseline |
| Quantitative method validation (antibody concentrations) | Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC. | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Immune cell repertoire sequencing | 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. | at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants will be selected from the database of all positive PCR cases for COVID-19 tested in the canton Basel-Land.
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| Name | Affiliation | Role |
|---|---|---|
| Miodrag Savic, Dr. med. | Department of Health, Economics and Health Directorate Canton Basel-Land | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Health, Economics and Health Directorate Canton Basel-Land | Liestal | 4410 | Switzerland |
The Biobank data is planned to be shared according to the Biobank regulatory approved by the EKNZ
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Immune cells (B cells and T cells) from peripheral blood mononuclear cells (PBMC) from the cohort of COVID-19 recovered patients will be subjected to bulk and single-cell RNA sequencing (RNA-seq). Biological material in this project is not identified by participant name but by a unique participant number. Biological material is appropriately stored in a restricted area only accessible to authorized personnel. Biobank is handled by the accredited diagnostic lab of the Swiss TPH according to the rules of clinical sample storage.
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| fingertip tests for POC assays | Diagnostic Test | performing POC test by taking two blood drops from the fingertip |
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| saliva collection | Diagnostic Test | 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. |
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| collection of swabs | Diagnostic Test | collection of nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation) |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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