| Published Version Download ( PDF | 880kB) | License: Creative Commons Attribution 4.0 |
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
and Wagner, Ralf
(2021)
Spectrum Bias and Individual Strengths of SARS-CoV-2 Serological Tests—A Population-Based Evaluation.
Diagnostics 11 (10), pp. 1-14.
Date of publication of this fulltext: 12 Jan 2022 15:30
Article
DOI to cite this document: 10.5283/epub.51408
Abstract
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.
Alternative links to fulltext
Involved Institutions
Details
| Item type | Article | ||||
| Journal or Publication Title | Diagnostics | ||||
| Publisher: | MDPI | ||||
|---|---|---|---|---|---|
| Open Access Type: | Gold (with APC) | ||||
| Place of Publication: | BASEL | ||||
| Volume: | 11 | ||||
| Number of Issue or Book Chapter: | 10 | ||||
| Page Range: | pp. 1-14 | ||||
| Date | 6 October 2021 | ||||
| Institutions | Medicine > Lehrstuhl für Klinische Chemie und Laboratoriumsmedizin Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene Medicine > Institut für Epidemiologie und Präventivmedizin > Lehrstuhl für Genetische Epidemiologie | ||||
| Identification Number |
| ||||
| Keywords | ; SARS-CoV-2; ELISA; ECLIA; neutralization; spectrum bias; serology; test accuracy; sensitivity; specificity | ||||
| Dewey Decimal Classification | 600 Technology > 610 Medical sciences Medicine | ||||
| Status | Published | ||||
| Refereed | Yes, this version has been refereed | ||||
| Created at the University of Regensburg | Yes | ||||
| URN of the UB Regensburg | urn:nbn:de:bvb:355-epub-514089 | ||||
| Item ID | 51408 |
Download Statistics
Download Statistics