Evaluation of a Broad Panel of SARS-CoV-2 Serological Tests for Diagnostic Use

Werner, Maren and Pervan, Philip and Glueck, Vivian and Zeman, Florian and Koller, Michael and Burkhardt, Ralph and Glueck, Thomas and Wenzel, Juergen J. and Schmidt, Barbara and Gessner, Andre and Peterhoff, David (2021) Evaluation of a Broad Panel of SARS-CoV-2 Serological Tests for Diagnostic Use. JOURNAL OF CLINICAL MEDICINE, 10 (8): 1580. ISSN , 2077-0383

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Abstract

Serological testing is crucial in detection of previous infection and in monitoring convalescent and vaccine-induced immunity. During the Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) pandemic, numerous assay platforms have been developed and marketed for clinical use. Several studies recently compared clinical performance of a limited number of serological tests, but broad comparative evaluation is currently missing. Within this study, a panel of 161 sera from SARS-CoV-2 infected, seasonal CoV-infected and SARS-CoV-2 naive subjects was enrolled to evaluate 16 ELISA/ECLIA-based and 16 LFA-based tests. Specificities of all ELISA/ECLIA-based assays were acceptable and generally in agreement with the providers' specifications, but sensitivities were lower as specified. Results of the LFAs were less accurate as compared to the ELISAs, albeit with some exceptions. We found a sporadic unequal immune response for different antigens and thus recommend the use of a nucleocapsid protein (N)- and spike protein (S)-based test combination when maximal sensitivity is necessary. Finally, the quality of the immune response in terms of neutralization should be tested using S-based IgG tests.

Item Type: Article
Uncontrolled Keywords: ASSAYS; IMMUNOASSAYS; ANTIBODIES; COVID-19; SARS-CoV-2; COVID-19; serological immune response; serological tests; ELISA; ECLIA; LFA
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Klinische Chemie und Laboratoriumsmedizin
Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene
Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Depositing User: Dr. Gernot Deinzer
Date Deposited: 19 Jul 2022 09:35
Last Modified: 19 Jul 2022 09:35
URI: https://pred.uni-regensburg.de/id/eprint/45816

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