Recent studies have revealed a prolonged T-cell immune response to SARS-CoV-2 after COVID-19 or seasonal coronavirus infection which is a more sensitive marker of past infection than humoral response. To better evaluate the efficacy of new vaccines and prioritize vaccination in different patient populations, new immuno-diagnostics are needed to measure the cellular immune response to SARS-CoV-2. Although significant progress has been made in the development of assays for detecting antibody responses to SARS-CoV-2, clinical assays for detecting cellular immune responses have been delayed. Interferon-gamma (IFN-γ) release assay (IGRA) is in vitro blood diagnostics used in clinical laboratories to measure IFN-γ released by antigen-specific T cells after overnight stimulation with pathogen-specific peptides.
Participants will enter into a “Pre-Release / Investigational Use Only (IUO) Product Agreement” with QIAGEN and receive IUO Kits, i.e. use only for study purposes. In other words, the test should not be used instead of confirmatory, well-established diagnostics.
Three patient groups are compared in their IGRA SARS-CoV-2 response: immunocompetent individuals after SARS-CoV-2 infection / or vaccination, patients over 70 years of age with SARS-CoV-2 vaccination, and vaccinated kidney transplant patients.
Purpose and goals: evaluate IGRA-SARS-CoV-2 at the microbiology department: workflow and results compared with established routine diagnostics in different patient groups, laboratory validation and evaluation of usefulness of IGRA SARS-CoV-2 assay.