COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses
- Conditions
- COVID-19 Infection
- Interventions
- Diagnostic Test: blood drawDiagnostic Test: fingertip tests for POC assaysDiagnostic Test: saliva collectionDiagnostic Test: collection of swabs
- Registration Number
- NCT04483908
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 477
- 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.
- continuous steroid therapy / chemotherapy / immunsuppressiva
- subject is treated for cancer
- severe autoimmune disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 blood draw 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. Cohort 3 blood draw 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. Cohort 3 collection of swabs 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. Cohort 3 saliva collection 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. Cohort 1 fingertip tests for POC assays 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. Cohort 1 saliva collection 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. Cohort 2 blood draw 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. Cohort 2 fingertip tests for POC assays 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. Cohort 2 saliva collection 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. Cohort 3 fingertip tests for POC assays 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. Cohort 4 blood draw 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Department of Health, Economics and Health Directorate Canton Basel-Land
🇨ðŸ‡Liestal, Switzerland