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Comparison of six commercially available SARS-CoV-2 antibody assays—Choice of assay depends on intended use

OBJECTIVES: Evaluate six commercial serological assays for detection of IgA, IgM or IgG SARS-CoV-2 antibodies in different disease severities. METHODS: Three lateral flow tests (LFTs) (Acro IgM/IgG, CTK IgM/IgG, Livzon IgM/IgG) and three ELISA assays (Euroimmun IgA and IgG, Wantai IgM) were included...

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Autores principales: Nilsson, Anna Christine, Holm, Dorte Kinggaard, Justesen, Ulrik Stenz, Gorm-Jensen, Thøger, Andersen, Nanna Skaarup, Øvrehus, Anne, Johansen, Isik Somuncu, Michelsen, Jens, Sprogøe, Ulrik, Lillevang, Søren Thue
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726521/
https://www.ncbi.nlm.nih.gov/pubmed/33310021
http://dx.doi.org/10.1016/j.ijid.2020.12.017
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author Nilsson, Anna Christine
Holm, Dorte Kinggaard
Justesen, Ulrik Stenz
Gorm-Jensen, Thøger
Andersen, Nanna Skaarup
Øvrehus, Anne
Johansen, Isik Somuncu
Michelsen, Jens
Sprogøe, Ulrik
Lillevang, Søren Thue
author_facet Nilsson, Anna Christine
Holm, Dorte Kinggaard
Justesen, Ulrik Stenz
Gorm-Jensen, Thøger
Andersen, Nanna Skaarup
Øvrehus, Anne
Johansen, Isik Somuncu
Michelsen, Jens
Sprogøe, Ulrik
Lillevang, Søren Thue
author_sort Nilsson, Anna Christine
collection PubMed
description OBJECTIVES: Evaluate six commercial serological assays for detection of IgA, IgM or IgG SARS-CoV-2 antibodies in different disease severities. METHODS: Three lateral flow tests (LFTs) (Acro IgM/IgG, CTK IgM/IgG, Livzon IgM/IgG) and three ELISA assays (Euroimmun IgA and IgG, Wantai IgM) were included. Application was evaluated using samples from 57 patients with a positive SARS-CoV-2 reverse transcription polymerase chain reaction, stratified according to disease severity. Specificity was assessed using historical samples from 200 blood donors. RESULTS: While IgM LFTs failed to detect SARS-CoV-2 antibodies in 37–84% of non-hospitalised patients, the Wantai IgM ELISA detected antibodies in 79%. The Euroimmun IgG ELISA detected antibodies in 95% of non-hospitalised patients. IgA, IgM and IgG ELISA levels were initially low, increased over time, and correlated with disease severity. LFT sensitivity declined in samples taken >28 days after symptom onset/resolution. The Livzon IgG LFT had the highest specificity (98.5%), followed by the Euroimmun IgG ELISA (96.2%). The specificity for Euroimmun IgA ELISA improved (≥97.5%) using a custom cut-off value (4.0). CONCLUSIONS: The sensitive and semi-quantitative ELISA assays are most appropriate for serologic detection of SARS-CoV-2 infection in mild cases. Livzon LFT and Euroimmun ELISA had the highest specificity among the IgG assays, making them most suitable for seroprevalence studies.
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spelling pubmed-77265212020-12-10 Comparison of six commercially available SARS-CoV-2 antibody assays—Choice of assay depends on intended use Nilsson, Anna Christine Holm, Dorte Kinggaard Justesen, Ulrik Stenz Gorm-Jensen, Thøger Andersen, Nanna Skaarup Øvrehus, Anne Johansen, Isik Somuncu Michelsen, Jens Sprogøe, Ulrik Lillevang, Søren Thue Int J Infect Dis Article OBJECTIVES: Evaluate six commercial serological assays for detection of IgA, IgM or IgG SARS-CoV-2 antibodies in different disease severities. METHODS: Three lateral flow tests (LFTs) (Acro IgM/IgG, CTK IgM/IgG, Livzon IgM/IgG) and three ELISA assays (Euroimmun IgA and IgG, Wantai IgM) were included. Application was evaluated using samples from 57 patients with a positive SARS-CoV-2 reverse transcription polymerase chain reaction, stratified according to disease severity. Specificity was assessed using historical samples from 200 blood donors. RESULTS: While IgM LFTs failed to detect SARS-CoV-2 antibodies in 37–84% of non-hospitalised patients, the Wantai IgM ELISA detected antibodies in 79%. The Euroimmun IgG ELISA detected antibodies in 95% of non-hospitalised patients. IgA, IgM and IgG ELISA levels were initially low, increased over time, and correlated with disease severity. LFT sensitivity declined in samples taken >28 days after symptom onset/resolution. The Livzon IgG LFT had the highest specificity (98.5%), followed by the Euroimmun IgG ELISA (96.2%). The specificity for Euroimmun IgA ELISA improved (≥97.5%) using a custom cut-off value (4.0). CONCLUSIONS: The sensitive and semi-quantitative ELISA assays are most appropriate for serologic detection of SARS-CoV-2 infection in mild cases. Livzon LFT and Euroimmun ELISA had the highest specificity among the IgG assays, making them most suitable for seroprevalence studies. The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2021-02 2020-12-10 /pmc/articles/PMC7726521/ /pubmed/33310021 http://dx.doi.org/10.1016/j.ijid.2020.12.017 Text en © 2020 The Authors Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Nilsson, Anna Christine
Holm, Dorte Kinggaard
Justesen, Ulrik Stenz
Gorm-Jensen, Thøger
Andersen, Nanna Skaarup
Øvrehus, Anne
Johansen, Isik Somuncu
Michelsen, Jens
Sprogøe, Ulrik
Lillevang, Søren Thue
Comparison of six commercially available SARS-CoV-2 antibody assays—Choice of assay depends on intended use
title Comparison of six commercially available SARS-CoV-2 antibody assays—Choice of assay depends on intended use
title_full Comparison of six commercially available SARS-CoV-2 antibody assays—Choice of assay depends on intended use
title_fullStr Comparison of six commercially available SARS-CoV-2 antibody assays—Choice of assay depends on intended use
title_full_unstemmed Comparison of six commercially available SARS-CoV-2 antibody assays—Choice of assay depends on intended use
title_short Comparison of six commercially available SARS-CoV-2 antibody assays—Choice of assay depends on intended use
title_sort comparison of six commercially available sars-cov-2 antibody assays—choice of assay depends on intended use
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726521/
https://www.ncbi.nlm.nih.gov/pubmed/33310021
http://dx.doi.org/10.1016/j.ijid.2020.12.017
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