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

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...

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Detalles Bibliográficos
Autores: Carretero, D, Giménez, E, Albert, E, Colomer, E, Montomoli, M, Hernani, R, Piñana, JL, Górriz, JL, Solano, C, Navarro, D
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p18333
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/18333
Access Level:acceso abierto
Palabra clave:SARS-CoV-2
Interferon-gamma release assay (IGRA)
T cells
Flow cytometry for intracellular staining
COVID-19
Descripción
Sumario: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 (R) 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-gamma) staining-based immunoassay (FC-ICS). Results Overall, the Roche Elecsys (R) 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-gamma 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-gamma T cells and IFN-gamma 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-na & iuml;ve 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.