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Related Concept Videos

Cytomegalovirus Disease01:27

Cytomegalovirus Disease

102
Cytomegalovirus (CMV) disease is caused by human cytomegalovirus, a double-stranded DNA virus of the Herpesviridae family. While primary CMV infection is often asymptomatic in immunocompetent individuals, the virus can cause severe disease in neonates and immunocompromised patients. CMV is the most common cause of congenital viral infection in the United States, and a major pathogen in solid organ and hematopoietic stem cell transplant recipients.CMV is transmitted via bodily fluids, sexual...
102

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Related Experiment Video

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qPCR Is a Sensitive and Rapid Method for Detection of Cytomegaloviral DNA in Formalin-fixed, Paraffin-embedded Biopsy Tissue
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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.

Enfermedades Infecciosas Y Microbiologia Clinica (English Ed.)
|January 15, 2026
PubMed
Summary

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.

Keywords:
Cell-mediated immunityChemiluminescence immunoassay (CLIA)CitomegalovirusCytomegalovirusEnsayo de quimioluminiscencia (CLIA)Inmunidad celular específicaLung transplantationTrasplante pulmonar

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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.