Performance of the Roche Elecsys® IGRA SARS-CoV-2 test for the detection and quantification of virus-reactive T cells in COVID-19-vaccinated immunosuppressed patients and healthy subjects

• Published in: European journal of clinical microbiology & infectious diseases Vol. 43; no. 7; pp. 1427 - 1436
• Main Authors: Carretero, Diego, Giménez, Estela, Albert, Eliseo, Colomer, Ester, Montomoli, Marco, Hernani, Rafael, Piñana, José Luis, Górriz, José Luis, Solano, Carlos, Navarro, David
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.07.2024; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Biomedical and Life Sciences; Biomedicine; CD4 antigen; CD8 antigen; COVID-19; COVID-19 - diagnosis; COVID-19 - immunology; COVID-19 vaccines; COVID-19 Vaccines - immunology; Cytometry; Female; Humans; Immunoassay; Immunoassay - methods; Immunoassays; Immunocompromised Host; Interferon-gamma - blood; Interferon-gamma - immunology; Interferon-gamma Release Tests - methods; Interferon-gamma Release Tests - standards; Internal Medicine; Kidney diseases; Lymphocytes; Lymphocytes T; Male; Medical Microbiology; Middle Aged; SARS-CoV-2 - immunology; Severe acute respiratory syndrome coronavirus 2; T-Lymphocytes - immunology; Viral diseases; γ-Interferon; Germany; COVID-19; Flow cytometry for intracellular staining; SARS-CoV-2; Interferon-gamma release assay (IGRA); T cells
• ISSN: 0934-9723; 1435-4373; 1435-4373
• DOI: 10.1007/s10096-024-04852-5

Purpose Comparing the performance of commercially available SARS-CoV-2 T-cell immunoassay responses may provide useful information for future observational or intervention studies as well as to their potential customers. Method Whole blood was collected from a total of 183 subjects fully vaccinated against COVID-19: 55 healthy controls (Group 1), 50 hematological patients (Group 2), 50 chronic kidney disease patients (Group 3), and 28 elderly nursing home residents (Group 4). Samples were tested with the Roche Elecsys® IGRA (Interferon-gamma release assay) SARS-CoV-2 test (Roche Diagnostics, Rotkreuz, Switzerland), the Euroimmun SARS-CoV-2 test (Euroimmun, Lubeck, Germany), the SARS-CoV-2 T Cell Analysis Kit (Miltenyi Biotec, Bergisch Gladbach, Germany), and a flow-cytometry for intracellular cytokine (IFN-γ) staining-based immunoassay (FC-ICS). Results Overall, the Roche Elecsys® assay returned the highest number of positive results (151/179; 84.3%), followed by the Euroimmun test (127/183; 69%), and the FC-ICS (135/179; 75%). The Kappa coefficient of agreement was best between IGRAs (0.64). Most discordant results across assays involved patients from Group 2. Overall, IFN-γ concentrations measured by both IGRAs correlated strongly (rho = 0.78; 95% CI 0.71–0.84; P  < 0.001) irrespective of the study group. The frequencies of SARS-CoV-2-reactive IFN-γ T cells and IFN-γ concentrations measured by the IGRAs correlated moderately for CD4 + T cells, however, weakly for CD8 + T cells. SARS-CoV-2-experienced participants displayed stronger responses than SARS-CoV-2-naïve when IGRAs, rather than FC-ICS, were used. Conclusion The SARS-CoV-2 immunoassays evaluated in the present study did not return interchangeable qualitative or quantitative results either in seemingly healthy individuals or in immunosuppressed patients.