Initial characterisation of commercially available ELISA tests and the immune response of the clinically correlated SARS-CoV-2 biobank “SERO-BL-COVID-19” collected during the pandemic onset in Switzerland
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Abstract
Background
To accurately measure seroprevalance in the population, both the expected immune response as well as the assay performances have to be well characterised. Here, we describe the collection and initial characterisation of a blood and saliva biobank obtained after the initial peak of the SARS-CoV-2 pandemic in Switzerland.
Methods
Two laboratory ELISAs measuring IgA & IgG (Euroimmun), and IgM & IgG (Epitope Diagnostics) were used to characterise the biobank collected from 349 re- and convalescent patients from the canton of Basel-Landschaft.
Findings
The antibody response in terms of recognized epitopes is diverse, especially in oligosymptomatic patients, while the average strength of the antibody response of the population does correlate with the severity of the disease at each time point.
Interpretation
The diverse immune response presents a challenge when conducting epidemiological studies as the used assays only detect ∼ 90% of the oligosymptomatic cases. This problem cannot be rectified by using more sensitive assay setting as they concomitantly reduce specificity.
Funding
Funding was obtained from the “Amt für Gesundheit” of the canton Basel-Landschaft, Switzerland.
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SciScore for 10.1101/2020.07.05.20145888: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics statement: This study is part of the project ‘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)’ approved by the ethics board “Ethikkommission Nordwestund Zentralschweiz (EKNZ)”, Hebelstrasse 53, 4056 Basel representative of Swissethics under the number (2020-00816).
Consent: Every participant has received a written informed consent at least 24 hours before participating in this study (attached original document in German language).Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological … SciScore for 10.1101/2020.07.05.20145888: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics statement: This study is part of the project ‘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)’ approved by the ethics board “Ethikkommission Nordwestund Zentralschweiz (EKNZ)”, Hebelstrasse 53, 4056 Basel representative of Swissethics under the number (2020-00816).
Consent: Every participant has received a written informed consent at least 24 hours before participating in this study (attached original document in German language).Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analysis: Patient data and results of POCTs were originally stored in the REDCap database system of the Canton Hospital Basel-Landschaft. REDCapsuggested: (REDCap, RRID:SCR_003445)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:However, our current data help to understand the limitations of the current antibody tests on the market and serve as the basis to interpret ongoing studies on other lab assay characterization, POCT performances and PBMC sequencing.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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