High-throughput immunoassays for SARS-CoV-2–considerable differences in performance when comparing three methods
(2021) In Infectious Diseases 53(10). p.805-810- Abstract
Background: The recently launched high-throughput assays for detecting antibodies against SARS-CoV-2 has contributed to the managing strategies for the COVID-19 pandemic. This study aimed to investigate the performance of three high-throughput assays and one rapid lateral flow test relative to regulatory authorities' recommended criteria. Methods: A total of 315 samples, including 150 pre-pandemic samples, 152 samples from SARS-CoV-2 RT-PCR positive individuals and 13 potentially cross-reactive samples were analysed with SARS-CoV-2 IgG (Abbott, Abbott Park, IL), Elecsys Anti-SARS-CoV-2 (Roche, Solna, Sweden), LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin, Saluggia, Italy) and 2019-nCOV IgG/IgM Rapid Test (Dynamiker Biotechnology Co., Tianjin,... (More)
Background: The recently launched high-throughput assays for detecting antibodies against SARS-CoV-2 has contributed to the managing strategies for the COVID-19 pandemic. This study aimed to investigate the performance of three high-throughput assays and one rapid lateral flow test relative to regulatory authorities' recommended criteria. Methods: A total of 315 samples, including 150 pre-pandemic samples, 152 samples from SARS-CoV-2 RT-PCR positive individuals and 13 potentially cross-reactive samples were analysed with SARS-CoV-2 IgG (Abbott, Abbott Park, IL), Elecsys Anti-SARS-CoV-2 (Roche, Solna, Sweden), LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin, Saluggia, Italy) and 2019-nCOV IgG/IgM Rapid Test (Dynamiker Biotechnology Co., Tianjin, China). Results: All assays performed with a high level of specificity ranging from 96.7% to 99.3%. Sensitivity differed more between the assays, Roche exhibiting the highest sensitivity of 98.7%. The corresponding figures for Abbott, DiaSorin and Dynamiker Biotechnology were 80.9%, 89.0% and 72.4%, respectively. Conclusions: The results of the evaluated SARS-CoV-2 assays vary considerably, as well as their ability to fulfil the performance criteria proposed by regulatory authorities. Introduction into clinical use in low-prevalent settings, should, therefore, be made with caution.
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- author
- Ekelund, Oskar ; Ekblom, Kim LU ; Somajo, Sofia LU ; Pattison-Granberg, Johanna ; Olsson, Karl and Petersson, Annika LU
- publishing date
- 2021
- type
- Contribution to journal
- publication status
- published
- keywords
- antibodies, COVID-19, immunology, SARS-CoV-2, serology
- in
- Infectious Diseases
- volume
- 53
- issue
- 10
- pages
- 6 pages
- publisher
- Taylor & Francis
- external identifiers
-
- scopus:85107335022
- pmid:34053400
- ISSN
- 2374-4235
- DOI
- 10.1080/23744235.2021.1931434
- language
- English
- LU publication?
- no
- additional info
- Publisher Copyright: © 2021 Society for Scandinavian Journal of Infectious Diseases.
- id
- ad849ee0-d8c9-4071-a199-36a9537c992a
- date added to LUP
- 2026-02-17 14:14:33
- date last changed
- 2026-02-18 07:45:59
@article{ad849ee0-d8c9-4071-a199-36a9537c992a,
abstract = {{<p>Background: The recently launched high-throughput assays for detecting antibodies against SARS-CoV-2 has contributed to the managing strategies for the COVID-19 pandemic. This study aimed to investigate the performance of three high-throughput assays and one rapid lateral flow test relative to regulatory authorities' recommended criteria. Methods: A total of 315 samples, including 150 pre-pandemic samples, 152 samples from SARS-CoV-2 RT-PCR positive individuals and 13 potentially cross-reactive samples were analysed with SARS-CoV-2 IgG (Abbott, Abbott Park, IL), Elecsys Anti-SARS-CoV-2 (Roche, Solna, Sweden), LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin, Saluggia, Italy) and 2019-nCOV IgG/IgM Rapid Test (Dynamiker Biotechnology Co., Tianjin, China). Results: All assays performed with a high level of specificity ranging from 96.7% to 99.3%. Sensitivity differed more between the assays, Roche exhibiting the highest sensitivity of 98.7%. The corresponding figures for Abbott, DiaSorin and Dynamiker Biotechnology were 80.9%, 89.0% and 72.4%, respectively. Conclusions: The results of the evaluated SARS-CoV-2 assays vary considerably, as well as their ability to fulfil the performance criteria proposed by regulatory authorities. Introduction into clinical use in low-prevalent settings, should, therefore, be made with caution.</p>}},
author = {{Ekelund, Oskar and Ekblom, Kim and Somajo, Sofia and Pattison-Granberg, Johanna and Olsson, Karl and Petersson, Annika}},
issn = {{2374-4235}},
keywords = {{antibodies; COVID-19; immunology; SARS-CoV-2; serology}},
language = {{eng}},
number = {{10}},
pages = {{805--810}},
publisher = {{Taylor & Francis}},
series = {{Infectious Diseases}},
title = {{High-throughput immunoassays for SARS-CoV-2–considerable differences in performance when comparing three methods}},
url = {{http://dx.doi.org/10.1080/23744235.2021.1931434}},
doi = {{10.1080/23744235.2021.1931434}},
volume = {{53}},
year = {{2021}},
}