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Implementing CLIA for QuantiFERON®-CMV testing: Optimizing cellular immune response against cytomegalovirus
Juliana Esperalba1, Maria Arnedo-Muñoz2, Ariadna Rando-Segura3
1Microbiology Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain; Genetics and Microbiology Department, Universitat Autònoma de Barcelona, Bellaterra, Spain; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain.
Chemiluminescence immunoassay (CLIA) offers a reliable alternative to ELISA for Cytomegalovirus (CMV) interferon-gamma release assays in transplant recipients. This method demonstrates excellent agreement and may improve laboratory efficiency.
Area of Science:
- Immunology
- Transplant Medicine
- Infectious Diseases
Background:
- Cytomegalovirus (CMV) infections are a major concern for solid organ transplant recipients.
- Interferon-gamma (IFN-γ) release assays, like QuantiFERON®-CMV (QTF-CMV), are crucial for managing CMV cellular immunity.
- Chemiluminescence immunoassay (CLIA) presents potential technical advantages over the standard ELISA method for QTF-CMV.
Purpose of the Study:
- To evaluate the performance of a CLIA-based assay (LIAISON® QuantiFERON®-TB Gold Plus) for quantifying IFN-γ in QTF-CMV testing.
- To compare the CLIA method directly against the established ELISA-based QuantiFERON®-CMV assay.
Main Methods:
- Retrospective analysis of 169 plasma samples from 85 lung transplant recipients.
- Quantification of IFN-γ using both ELISA (Qiagen®) and CLIA (DiaSorin®) platforms.
- Statistical comparison included correlation coefficients, Bland-Altman analysis, ROC curves, Kappa index, sensitivity, and specificity.
Main Results:
- CLIA produced significantly higher IFN-γ levels compared to ELISA for both specific (CMV-NIL) and nonspecific (MIT-NIL) responses.
- High correlation (r and ρc >0.93) and diagnostic agreement (95.86%, Kappa=0.913) were observed between the two methods.
- CLIA showed fewer indeterminate results (3.55% vs 4.73%) and achieved 100% sensitivity and specificity with an optimal cut-off of 0.2754 IU/mL.
Conclusions:
- The CLIA method demonstrates excellent agreement with ELISA for QTF-CMV testing, establishing it as a reliable alternative.
- CLIA offers potential for improved laboratory workflows due to its automatable nature.
- Adjusting the cut-off value is recommended for optimal diagnostic accuracy when using CLIA for QTF-CMV.
