Correlation between a quantitative anti‐SARS‐CoV‐2 IgG ELISA and neutralization activity

Dolscheid‐Pommerich, Ramona; Bartok, Eva; Renn, Marcel; Kümmerer, Beate M.; Schulte, Bianca; Schmithausen, Ricarda M.; Stoffel‐Wagner, Birgit; Streeck, Hendrik; Saschenbrecker, Sandra; Steinhagen, Katja; Hartmann, Gunther

In the current COVID‐19 pandemic, a better understanding of the relationship between merely binding and functionally neutralizing antibodies is necessary to characterize protective antiviral immunity following infection or vaccination. This study analyzes the level of correlation between the novel quantitative EUROIMMUN Anti‐SARS‐CoV‐2 QuantiVac ELISA (IgG) and a microneutralization assay. A panel of 123 plasma samples from a COVID‐19 outbreak study population, preselected by semiquantitative anti‐SARS‐CoV‐2 IgG testing, was used to assess the relationship between the novel quantitative ELISA (IgG) and a microneutralization assay. Binding IgG targeting the S1 antigen was detected in 106 (86.2%) samples using the QuantiVac ELISA, while 89 (72.4%) samples showed neutralizing antibody activity. Spearman's correlation analysis demonstrated a strong positive relationship between anti‐S1 IgG levels and neutralizing antibody titers (r (s )= 0.819, p < 0.0001). High and low anti‐S1 IgG levels were associated with a positive predictive value of 72.0% for high‐titer neutralizing antibodies and a negative predictive value of 90.8% for low‐titer neutralizing antibodies, respectively. These results substantiate the implementation of the QuantiVac ELISA to assess protective immunity following infection or vaccination.