Assessing the Quality of Serological Testing in the COVID-19 Pandemic: Results of a European External Quality Assessment (EQA) Scheme for Anti-SARS-CoV-2 Antibody Detection

Author:

Ast Volker1,Costina Victor1,Eichner Romy1,Bode Anna2,Aida Sihem1,Gerhards Catharina1,Thiaucourt Margot1,Dobler Gerhard34,Geilenkeuser Wolf-Jochen2,Wölfel Roman34,Neumaier Michael1,Haselmann Verena1ORCID

Affiliation:

1. Department of Clinical Chemistry, University Medical Centre Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany

2. Reference-Institute for Bioanalytics, German Society for Clinical Chemistry and Laboratory Medicine (DGKL), Bonn, Germany

3. Bundeswehr Institute of Microbiology, Munich, Germany

4. German Center for Infection Research (DZIF), Partner Site Munich, Germany

Abstract

External quality assessment (EQA) is a key instrument for achieving harmonization, and thus a high quality, of diagnostic procedures. As reliable test results are crucial for accurate assessment of SARS-CoV-2 infection prevalence, vaccine response, and immunity, and thus for successful management of the ongoing COVID-19 pandemic, the Reference Institute for Bioanalytics (RfB) was the first EQA provider to offer an open scheme for anti-SARS-CoV-2 antibody detection.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference38 articles.

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2. European Commission. COVID-19 in vitro diagnostic devices and test methods database. https://covid-19-diagnostics.jrc.ec.europa.eu/devices?manufacturer&text_name&marking&rapid_diag&format&target_type&field-1=Assay%20category&value-1=3&field-2=Assay%20category&value-2=4&search_method=OR#form_content.

3. U.S. Food & Drug Administration. Insight into FDA’s revised policy on antibody tests: prioritizing access and accuracy. https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracy.

4. U.S. Food & Drug Administration. EUA authorized serology test performance. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance.

5. Comparison of test performance of commercial anti-SARS-CoV-2 immunoassays in serum and plasma samples

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