Head-to-Head Comparison of 5 Anti-SARS-CoV-2 Assays Performance in One Hundred COVID-19 Vaccinees, over an 8-Month Course

Abstract

The immunoassays used to measure anti-spike SARS-CoV-2 antibodies are widely available on the market. However, their performance in COVID-19 vaccinees is not yet adequately assessed. Our study provides a head-to-head comparison of five methods: Abbott’s S1-RBD IgG, Roche’s S1-RBD total antibody, Euroimmun’s S1 IgG, and DiaSorin’s TrimericS IgG and S1/S2 IgG assays. Testing was performed in one hundred vaccinated subjects, at eight timepoints over eight months after vaccination. The results differed substantially between methods; however, they correlated strongly and demonstrated the individuals’ responses to both doses of vaccination and the waning of humoral immunity after eight months. Importantly, we encountered a high percentage of results above the assay-specific upper quantitation limit (UQL) for undiluted samples. This was the most pronounced for the Roche’s and Euroimmun’s assays. The Abbott’s assay showed the lowest percentage of results above the UQL. We also attempted to find a common way to establish antibody concentrations that might be classified as high. However, this resulted in between 10% and 100% of such results for different methods on day 240′. This highlights the need for an assay-specific approach for adjusting the cut-offs that may indicate COVID-19 immunity.

Keywords

• COVID-19
• SARS-CoV-2
• vaccination
• assay comparison
• humoral immunity
• immunoassay