SARS-CoV-2 antibody testing—questions to be asked - 22/07/20

Doi : 10.1016/j.jaci.2020.05.020

Mustafa K. Özçürümez, MD ^a,^⁎ , Andreas Ambrosch, MD ^b,^{^{∗
Co-authors are listed in alphabetical order.}}, Oliver Frey, MD ^c,^d,^{^{∗
Co-authors are listed in alphabetical order.}}, Verena Haselmann, MD ^e,^{^{∗
Co-authors are listed in alphabetical order.}}, Stefan Holdenrieder, MD ^f,^{^{∗
Co-authors are listed in alphabetical order.}}, Michael Kiehntopf, MD ^g,^{^{∗
Co-authors are listed in alphabetical order.}}, Michael Neumaier, MD ^e,^{^{∗
Co-authors are listed in alphabetical order.}}, Michael Walter, MD ^h,^i,^{^{∗
Co-authors are listed in alphabetical order.}}, Folker Wenzel, MD ^j,^{^{∗
Co-authors are listed in alphabetical order.}}, Roman Wölfel, MD ^k,^l,^{^{∗
Co-authors are listed in alphabetical order.}}, Harald Renz, MD ^m,^{^{∗
Co-authors are listed in alphabetical order.}}
on behalf of the
COVID-19 Task Force of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL)
^a Department of Laboratory Medicine of the Medical Clinic at the University Medical Center Knappschaftskrankenhaus Bochum, Ruhr University, Bochum, Germany
^b Institute of Laboratory Medicine, Microbiology and Hygiene, Barmherzige Brüder Hospital, Regensburg, Germany
^c Institute of Laboratory Medicine, Brandenburg Medical School, Brandenburg an der Havel, Germany
^d Institute of Medical Diagnostics, Berlin, Germany
^e Institute of Clinical Chemistry, University Medicine Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany
^f Institute for Laboratory Medicine, German Heart Centre, Technical University Munich, Munich, Germany
^g Department of Clinical Chemistry and Laboratory Medicine, Jena University Hospital, Jena, Germany
^h Institute of Clinical Chemistry and Laboratory Medicine, Rostock University Medical Center, Rostock, Germany
ⁱ Institute of Laboratory Medicine, Clinical Chemistry, and Pathobiochemistry, Charité University Medical Center, Berlin, Germany
^j Faculty of Medical and Life Sciences, Hochschule Furtwangen, Furtwangen, Germany
^k Bundeswehr Institute of Microbiology, Munich, Germany
^l German Center for Infection Research (DZIF), Partner Site Munich, Munich, Germany
^m Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Philipps Universität Marburg, German Center for Lung Research (DZL), Marburg, Germany

^∗Corresponding author: Mustafa K. Özçürümez, MD, Department of Laboratory Medicine of the Medical Clinic at the University Medical Center, Knappschaftskrankenhaus Bochum, Ruhr University, In der Schornau 23-25, 44892 Bochum, Germany.Department of Laboratory Medicine of the Medical Clinic at the University Medical CenterKnappschaftskrankenhaus BochumRuhr UniversityIn der Schornau 23-25Bochum44892Germany

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Abstract

Severe acute respiratory syndrome coronavirus 2 infection and development of coronavirus disease 2019 presents a major health care challenge of global dimensions. Laboratory diagnostics of infected patients, and the assessment of immunity against severe acute respiratory syndrome coronavirus 2, presents a major cornerstone in handling the pandemic. Currently, there is an increase in demand for antibody testing and a large number of tests are already marketed or are in the late stage of development. However, the interpretation of test results depends on many variables and factors, including sensitivity, specificity, potential cross-reactivity and cross-protectivity, the diagnostic value of antibodies of different isotypes, and the use of antibody testing in identification of acutely ill patients or in epidemiological settings. In this article, the recently established COVID-19 Task Force of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) addresses these issues on the basis of currently available data sets in this rapidly moving field.

Le texte complet de cet article est disponible en PDF.

Key words : Antibody response, COVID-19, diagnostic pathway, external quality assurance, immunity, immunoassay, neutralization assay, respiratory tract infections, serologic tests, severe acute respiratory syndrome coronavirus 2

Abbreviations used : COVID-19, EQA, NPV, PPV, SARS, SARS-CoV-2

Plan

What are the approved indications to perform a COVID-19 serology?

How valuable is SARS-CoV-2 antibody testing in diagnostic pathways?

Do SARS-CoV-2–specific antibodies indicate the end of infectivity?

What does the detection of neutralizing antibodies imply about the immunity against SARS-CoV-2?

How do the available assay technologies differ in their conclusiveness?

How to ensure the quality of available assays?

Why should baseline samples be collected from still asymptomatic or healthy individuals?

Can laboratories estimate the medium-term demand for SARS-CoV-2 antibody tests?

Perspective and conclusions

	H.R. is funded by the Universities Giessen Marburg Lung Center (UGMLC) and the German Center for Lung Disease (DZL German Lung Center, no. 82DZL00502) for UGMLC.
	Disclosure of potential conflict of interest: The authors declare that they have no relevant conflicts of interest.