Performance evaluation of serological assays to determine the immunoglobulin status in SARS-CoV-2 infected patients
Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved..
BACKGROUND: Serological assays for the determination of the immune status of patients that have tested positive for infection with SARS-CoV-2 by RT-PCR are required for, e.g., contact tracing and epidemiological studies. However, data concerning the performance parameters of commercially available high-throughput ELISA tests are still not available on a large scale.
STUDY DESIGN: In our study, we have evaluated an in-house developed ELISA for the detection of the immunoglobulin classes A, G and M directed against the full-length spike glycoprotein from SARS-CoV-2. For this analysis, we have included 110 sera from patients presenting with COVID-19 symptoms or blood donors without symptoms collected at the Austrian Red Cross, Blood Transfusion Service for Upper Austria, Linz. In addition, we have selected four commercially available IgG-based ELISAs as well as one IgA/IgG-based ELISA for the detection of SARS-CoV-2 antigens as well as a multiplexed IgG-based micro-ELISA assay developed for rapid Point of Care testing applications.
CONCLUSIONS: All assays evaluated in the course of this study demonstrated suitable sensitivity and specificity values for the identification of patients that have experienced a past infection with SARS-CoV-2. However, testing for the presence of additional immunoglobulins (IgA and IgM) as well as using combinations of different viral antigens is highly advised to improve the predictive values of serological assays.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:131 |
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| Enthalten in: |
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - 131(2020) vom: 01. Okt., Seite 104589 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wechselberger, Christian [VerfasserIn] |
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| Links: |
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| Themen: |
Antibodies, Viral |
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| Anmerkungen: |
Date Completed 05.10.2020 Date Revised 18.12.2020 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jcv.2020.104589 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM313848580 |
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| 500 | |a Date Revised 18.12.2020 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved. | ||
| 520 | |a BACKGROUND: Serological assays for the determination of the immune status of patients that have tested positive for infection with SARS-CoV-2 by RT-PCR are required for, e.g., contact tracing and epidemiological studies. However, data concerning the performance parameters of commercially available high-throughput ELISA tests are still not available on a large scale | ||
| 520 | |a STUDY DESIGN: In our study, we have evaluated an in-house developed ELISA for the detection of the immunoglobulin classes A, G and M directed against the full-length spike glycoprotein from SARS-CoV-2. For this analysis, we have included 110 sera from patients presenting with COVID-19 symptoms or blood donors without symptoms collected at the Austrian Red Cross, Blood Transfusion Service for Upper Austria, Linz. In addition, we have selected four commercially available IgG-based ELISAs as well as one IgA/IgG-based ELISA for the detection of SARS-CoV-2 antigens as well as a multiplexed IgG-based micro-ELISA assay developed for rapid Point of Care testing applications | ||
| 520 | |a CONCLUSIONS: All assays evaluated in the course of this study demonstrated suitable sensitivity and specificity values for the identification of patients that have experienced a past infection with SARS-CoV-2. However, testing for the presence of additional immunoglobulins (IgA and IgM) as well as using combinations of different viral antigens is highly advised to improve the predictive values of serological assays | ||
| 650 | 4 | |a Evaluation Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a ELISA | |
| 650 | 4 | |a Evaluation | |
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| 650 | 4 | |a SARS-CoV-2 | |
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| 700 | 1 | |a Doppler, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Bernhard, David |e verfasserin |4 aut | |
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