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Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study
This study assessed the diagnostic performance of the new COVID19SEROSpeed IgM/IgG rapid test (BioSpeedia, a spinoff of the Pasteur Institute of Paris) for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in comparison to other commercial antibody assa...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Society for Microbiology
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111158/ https://www.ncbi.nlm.nih.gov/pubmed/33218990 http://dx.doi.org/10.1128/JCM.02240-20 |
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author | Plebani, Mario Parčina, Marijo Bechri, Issam Zehender, Gianguglielmo Terkeš, Vedrana Abdel Hafith, Balqis Antinori, Spinello Pillet, Sylvie Gonzalo, Sylvie Hoerauf, Achim Lai, Alessia Morović, Miro Bourlet, Thomas Torre, Alessandro Pozzetto, Bruno Galli, Massimo |
author_facet | Plebani, Mario Parčina, Marijo Bechri, Issam Zehender, Gianguglielmo Terkeš, Vedrana Abdel Hafith, Balqis Antinori, Spinello Pillet, Sylvie Gonzalo, Sylvie Hoerauf, Achim Lai, Alessia Morović, Miro Bourlet, Thomas Torre, Alessandro Pozzetto, Bruno Galli, Massimo |
author_sort | Plebani, Mario |
collection | PubMed |
description | This study assessed the diagnostic performance of the new COVID19SEROSpeed IgM/IgG rapid test (BioSpeedia, a spinoff of the Pasteur Institute of Paris) for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in comparison to other commercial antibody assays through a large cross-European investigation. The clinical specificity was assessed on 215 prepandemic sera (including some from patients with viral infections or autoimmune disorders). The clinical sensitivity was evaluated on 710 sera from 564 patients whose SARS-CoV-2 infection was confirmed by quantitative reverse transcription-PCR (qRT-PCR) and whose antibody response was compared to that measured by five other commercial tests. The kinetics of the antibody response were also analyzed in seven symptomatic patients. The specificity of the test (BioS) on prepandemic specimens was 98.1% (95% confidence interval [CI], 96.2% to 99.4%). When tested on the 710 pandemic specimens, BioS showed an overall clinical sensitivity of 86.0% (95% CI, 0.83 to 0.89), with good concordance with the Euroimmun assay (overall concordance of 0.91; Cohen’s kappa coefficient of 0.62). Due in part to simultaneous detection of IgM and IgG for both S1 and N proteins, BioS exhibited the highest positive percent agreement at ≥11 days post-symptom onset (PSO). In conclusion, the BioS IgM/IgG rapid test was highly specific and demonstrated a higher positive percentage of agreement than all the enzyme-linked immunosorbent assay/chemiluminescence immunoassay (ELISA/CLIA) commercial tests considered in this study. Moreover, by detecting the presence of antibodies prior to 11 days PSO in 78.2% of the patients, the BioS test increased the efficiency of the diagnosis of SARS-CoV-2 infection in the early stages of the disease. |
format | Online Article Text |
id | pubmed-8111158 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | American Society for Microbiology |
record_format | MEDLINE/PubMed |
spelling | pubmed-81111582021-05-28 Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study Plebani, Mario Parčina, Marijo Bechri, Issam Zehender, Gianguglielmo Terkeš, Vedrana Abdel Hafith, Balqis Antinori, Spinello Pillet, Sylvie Gonzalo, Sylvie Hoerauf, Achim Lai, Alessia Morović, Miro Bourlet, Thomas Torre, Alessandro Pozzetto, Bruno Galli, Massimo J Clin Microbiol Immunoassays This study assessed the diagnostic performance of the new COVID19SEROSpeed IgM/IgG rapid test (BioSpeedia, a spinoff of the Pasteur Institute of Paris) for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in comparison to other commercial antibody assays through a large cross-European investigation. The clinical specificity was assessed on 215 prepandemic sera (including some from patients with viral infections or autoimmune disorders). The clinical sensitivity was evaluated on 710 sera from 564 patients whose SARS-CoV-2 infection was confirmed by quantitative reverse transcription-PCR (qRT-PCR) and whose antibody response was compared to that measured by five other commercial tests. The kinetics of the antibody response were also analyzed in seven symptomatic patients. The specificity of the test (BioS) on prepandemic specimens was 98.1% (95% confidence interval [CI], 96.2% to 99.4%). When tested on the 710 pandemic specimens, BioS showed an overall clinical sensitivity of 86.0% (95% CI, 0.83 to 0.89), with good concordance with the Euroimmun assay (overall concordance of 0.91; Cohen’s kappa coefficient of 0.62). Due in part to simultaneous detection of IgM and IgG for both S1 and N proteins, BioS exhibited the highest positive percent agreement at ≥11 days post-symptom onset (PSO). In conclusion, the BioS IgM/IgG rapid test was highly specific and demonstrated a higher positive percentage of agreement than all the enzyme-linked immunosorbent assay/chemiluminescence immunoassay (ELISA/CLIA) commercial tests considered in this study. Moreover, by detecting the presence of antibodies prior to 11 days PSO in 78.2% of the patients, the BioS test increased the efficiency of the diagnosis of SARS-CoV-2 infection in the early stages of the disease. American Society for Microbiology 2021-01-21 /pmc/articles/PMC8111158/ /pubmed/33218990 http://dx.doi.org/10.1128/JCM.02240-20 Text en Copyright © 2021 Plebani et al. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Immunoassays Plebani, Mario Parčina, Marijo Bechri, Issam Zehender, Gianguglielmo Terkeš, Vedrana Abdel Hafith, Balqis Antinori, Spinello Pillet, Sylvie Gonzalo, Sylvie Hoerauf, Achim Lai, Alessia Morović, Miro Bourlet, Thomas Torre, Alessandro Pozzetto, Bruno Galli, Massimo Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study |
title | Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study |
title_full | Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study |
title_fullStr | Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study |
title_full_unstemmed | Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study |
title_short | Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study |
title_sort | performance of the covid19serospeed igm/igg rapid test, an immunochromatographic assay for the diagnosis of sars-cov-2 infection: a multicenter european study |
topic | Immunoassays |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111158/ https://www.ncbi.nlm.nih.gov/pubmed/33218990 http://dx.doi.org/10.1128/JCM.02240-20 |
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