PuSH - Publication Server of Helmholtz Zentrum München: Impact of Omicron variant infection on assessment of spike-specific Immune responses using EUROIMMUN Quan-T-Cell SARS-CoV-2 assay and Roche Elecsys anti-SARS-CoV-2-S.

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Ahmed, M.I.M.* ; Plank, M.* ; Castelletti, N. ; Diepers, P.* ; Eser, T.M.* ; Rubio-Acero, R.* ; Noreña, I.* ; Reinkemeyer, C.* ; Zapf, D.* ; Hoelscher, M.* ; Janke, C.* ; Wieser, A.* ; Geldmacher, C.*

Impact of Omicron variant infection on assessment of spike-specific Immune responses using EUROIMMUN Quan-T-Cell SARS-CoV-2 assay and Roche Elecsys anti-SARS-CoV-2-S.

Diagnostics 13:9 (2023)

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The currently prevailing variants of SARS-CoV-2 are subvariants of the Omicron variant. The aim of this study was to analyze the effect of mutations in the Spike protein of Omicron on the results Quan-T-Cell SARS-CoV-2 assays and Roche Elecsys anti-SARS-CoV-2 anti-S1. Omicron infected subjects ((n = 37), vaccinated (n = 20) and unvaccinated (n = 17)) were recruited approximately 3 weeks after a positive PCR test. The Quan-T-Cell SARS-CoV-2 assays (EUROIMMUN) using Wuhan and the Omicron adapted antigen assay and a serological test (Roche Elecsys anti-SARS-CoV-2 anti-S1) were performed. Using the original Wuhan SARS-CoV-2 IGRA TUBE, in 19 of 21 tested Omicron infected subjects, a positive IFNy response was detected, while 2 non-vaccinated but infected subjects did not respond. The Omicron adapted antigen tube resulted in comparable results. In contrast, the serological assay detected a factor 100-fold lower median Spike-specific RBD antibody concentration in non-vaccinated Omicron infected patients (n = 12) compared to patients from the pre Omicron era (n = 12) at matched time points, and eight individuals remained below the detection threshold for positivity. For vaccinated subjects, the Roche assay detected antibodies in all subjects and showed a 400 times higher median specific antibody concentration compared to non-vaccinated infected subjects in the pre-Omicron era. Our results suggest that Omicron antigen adapted IGRA stimulator tubes did not improve detection of SARS-CoV-2-specific T-cell responses in the Quant-T-Cell-SARS-CoV-2 assay. In non-vaccinated Omicron infected individuals, the Wuhan based Elecsys anti-SARS-CoV-2 anti-S1 serological assay results in many negative results at 3 weeks after diagnosis.

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