Determining the SARS-CoV-2 Anti-Spike Cutoff Level Denoting Neutralizing Activity Using Two Commercial Kits

Background: The viral neutralization assay is the gold standard to estimate the level of immunity against SARS-CoV-2. This study analyzes the correlation between the quantitative Anti-SARS-CoV-2 QuantiVac ELISA (IgG) and the NeutraLISA neutralization assay. Methods: 650 serum samples were tested for...

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Main Authors: Engy Mohamed El-Ghitany, Mona H. Hashish, Azza Galal Farghaly, Eman A. Omran
Format: Article
Language:English
Published: MDPI AG 2022-11-01
Series:Vaccines
Subjects:
Online Access:https://www.mdpi.com/2076-393X/10/11/1952
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author Engy Mohamed El-Ghitany
Mona H. Hashish
Azza Galal Farghaly
Eman A. Omran
author_facet Engy Mohamed El-Ghitany
Mona H. Hashish
Azza Galal Farghaly
Eman A. Omran
author_sort Engy Mohamed El-Ghitany
collection DOAJ
description Background: The viral neutralization assay is the gold standard to estimate the level of immunity against SARS-CoV-2. This study analyzes the correlation between the quantitative Anti-SARS-CoV-2 QuantiVac ELISA (IgG) and the NeutraLISA neutralization assay. Methods: 650 serum samples were tested for both SARS-CoV-2 anti-spike (anti-S) immunoglobulin G (IgG) and neutralizing antibodies (nAbs) using kits by EUROIMMUN, Germany. Results: There was a significant correlation between levels of anti-S and nAbs (Spearman’s rho = 0.913). Among the positive samples for anti-S, 77.0% (n = 345) were positive for nAbs. There was a substantial agreement between anti-S and nAbs (Cohen’s kappa coefficient = 0.658; agreement of 83.38%). Considering NeutraLISA as a gold standard, anti-S had a sensitivity of 98.57%, specificity of 65.66%, NPV of 97.5%, and PPV of 77.0%. When the anti-S titer was greater than 18.1 RU/mL (57.9 BAU/mL), nAbs were positive, with a sensitivity of 90.0% and specificity of 91%. Conclusions: A titer of SARS-CoV-2 anti-S IgG can be correlated with levels of nAbs.
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spelling doaj.art-c6dbd0bb6ba94c5987fc3008b802aa822023-11-24T10:17:11ZengMDPI AGVaccines2076-393X2022-11-011011195210.3390/vaccines10111952Determining the SARS-CoV-2 Anti-Spike Cutoff Level Denoting Neutralizing Activity Using Two Commercial KitsEngy Mohamed El-Ghitany0Mona H. Hashish1Azza Galal Farghaly2Eman A. Omran3Department of Tropical Health, High Institute of Public Health, Alexandria University, Alexandria 21526, EgyptDepartment of Microbiology, High Institute of Public Health, Alexandria University, Alexandria 21526, EgyptDepartment of Tropical Health, High Institute of Public Health, Alexandria University, Alexandria 21526, EgyptDepartment of Microbiology, High Institute of Public Health, Alexandria University, Alexandria 21526, EgyptBackground: The viral neutralization assay is the gold standard to estimate the level of immunity against SARS-CoV-2. This study analyzes the correlation between the quantitative Anti-SARS-CoV-2 QuantiVac ELISA (IgG) and the NeutraLISA neutralization assay. Methods: 650 serum samples were tested for both SARS-CoV-2 anti-spike (anti-S) immunoglobulin G (IgG) and neutralizing antibodies (nAbs) using kits by EUROIMMUN, Germany. Results: There was a significant correlation between levels of anti-S and nAbs (Spearman’s rho = 0.913). Among the positive samples for anti-S, 77.0% (n = 345) were positive for nAbs. There was a substantial agreement between anti-S and nAbs (Cohen’s kappa coefficient = 0.658; agreement of 83.38%). Considering NeutraLISA as a gold standard, anti-S had a sensitivity of 98.57%, specificity of 65.66%, NPV of 97.5%, and PPV of 77.0%. When the anti-S titer was greater than 18.1 RU/mL (57.9 BAU/mL), nAbs were positive, with a sensitivity of 90.0% and specificity of 91%. Conclusions: A titer of SARS-CoV-2 anti-S IgG can be correlated with levels of nAbs.https://www.mdpi.com/2076-393X/10/11/1952COVID-19neutralizing antibodiesspike antibodiesreceiver operating characteristic (ROC) curvecutoff point
spellingShingle Engy Mohamed El-Ghitany
Mona H. Hashish
Azza Galal Farghaly
Eman A. Omran
Determining the SARS-CoV-2 Anti-Spike Cutoff Level Denoting Neutralizing Activity Using Two Commercial Kits
Vaccines
COVID-19
neutralizing antibodies
spike antibodies
receiver operating characteristic (ROC) curve
cutoff point
title Determining the SARS-CoV-2 Anti-Spike Cutoff Level Denoting Neutralizing Activity Using Two Commercial Kits
title_full Determining the SARS-CoV-2 Anti-Spike Cutoff Level Denoting Neutralizing Activity Using Two Commercial Kits
title_fullStr Determining the SARS-CoV-2 Anti-Spike Cutoff Level Denoting Neutralizing Activity Using Two Commercial Kits
title_full_unstemmed Determining the SARS-CoV-2 Anti-Spike Cutoff Level Denoting Neutralizing Activity Using Two Commercial Kits
title_short Determining the SARS-CoV-2 Anti-Spike Cutoff Level Denoting Neutralizing Activity Using Two Commercial Kits
title_sort determining the sars cov 2 anti spike cutoff level denoting neutralizing activity using two commercial kits
topic COVID-19
neutralizing antibodies
spike antibodies
receiver operating characteristic (ROC) curve
cutoff point
url https://www.mdpi.com/2076-393X/10/11/1952
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