Direkt zum Inhalt

Einhauser, Sebastian ; Peterhoff, David ; Niller, Hans Helmut ; Beileke, Stephanie ; Günther, Felix ; Steininger, Philipp ; Burkhardt, Ralph ; Heid, Iris M. ; Pfahlberg, Annette B. ; Überla, Klaus ; Gefeller, Olaf ; Wagner, Ralf

Spectrum Bias and Individual Strengths of SARS-CoV-2 Serological Tests—A Population-Based Evaluation

Einhauser, Sebastian , Peterhoff, David , Niller, Hans Helmut, Beileke, Stephanie, Günther, Felix, Steininger, Philipp, Burkhardt, Ralph , Heid, Iris M., Pfahlberg, Annette B. , Überla, Klaus , Gefeller, Olaf und Wagner, Ralf (2021) Spectrum Bias and Individual Strengths of SARS-CoV-2 Serological Tests—A Population-Based Evaluation. Diagnostics 11 (10), S. 1-14.

Veröffentlichungsdatum dieses Volltextes: 12 Jan 2022 15:30
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.51408


Zusammenfassung

Antibody testing for determining the SARS-CoV-2 serostatus was rapidly introduced in early 2020 and since then has been gaining special emphasis regarding correlates of protection. With limited access to representative samples with known SARS-CoV-2 infection status during the initial period of test development and validation, spectrum bias has to be considered when moving from a "test ...

Antibody testing for determining the SARS-CoV-2 serostatus was rapidly introduced in early 2020 and since then has been gaining special emphasis regarding correlates of protection. With limited access to representative samples with known SARS-CoV-2 infection status during the initial period of test development and validation, spectrum bias has to be considered when moving from a "test establishment setting " to population-based settings, in which antibody testing is currently implemented. To provide insights into the presence and magnitude of spectrum bias and to estimate performance measures of antibody testing in a population-based environment, we compared SARS-CoV-2 neutralization to a battery of serological tests and latent class analyses (LCA) in a subgroup (n = 856) of the larger population based TiKoCo-19 cohort (n = 4185). Regarding spectrum bias, we could proof notable differences in test sensitivities and specificities when moving to a population-based setting, with larger effects visible in earlier registered tests. While in the population-based setting the two Roche ELECSYS anti-SARS-CoV-2 tests outperformed every other test and even LCA regarding sensitivity and specificity in dichotomous testing, they didn't provide satisfying quantitative correlation with neutralization capacity. In contrast, our in-house anti SARS-CoV-2-Spike receptor binding domain (RBD) IgG-ELISA (enzyme-linked-immunosorbant assay) though inferior in dichotomous testing, provided satisfactory quantitative correlation and may thus represent a better correlate of protection. In summary, all tests, led by the two Roche tests, provided sufficient accuracy for dichotomous identification of neutralizing sera, with increasing spectrum bias visible in earlier registered tests, while the majority of tests, except the RBD-ELISA, didn't provide satisfactory quantitative correlations.



Beteiligte Einrichtungen


Details

DokumentenartArtikel
Titel eines Journals oder einer ZeitschriftDiagnostics
Verlag:MDPI
Ort der Veröffentlichung:BASEL
Band:11
Nummer des Zeitschriftenheftes oder des Kapitels:10
Seitenbereich:S. 1-14
Datum6 Oktober 2021
InstitutionenMedizin > Lehrstuhl für Klinische Chemie und Laboratoriumsmedizin
Medizin > Lehrstuhl für Medizinische Mikrobiologie und Hygiene
Medizin > Institut für Epidemiologie und Präventivmedizin > Lehrstuhl für Genetische Epidemiologie
Identifikationsnummer
WertTyp
10.3390/diagnostics11101843DOI
Stichwörter / Keywords; SARS-CoV-2; ELISA; ECLIA; neutralization; spectrum bias; serology; test accuracy; sensitivity; specificity
Dewey-Dezimal-Klassifikation600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin
StatusVeröffentlicht
BegutachtetJa, diese Version wurde begutachtet
An der Universität Regensburg entstandenJa
URN der UB Regensburgurn:nbn:de:bvb:355-epub-514089
Dokumenten-ID51408

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