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

Abstract

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.