SARS-CoV-2 antibody testing-questions to be asked

J Allergy Clin Immunol. 2020 Jul;146(1):35-43. doi: 10.1016/j.jaci.2020.05.020. Epub 2020 May 29.


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.

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