Introduction
Cytomegalovirus (CMV) remains a significant infectious complication in solid organ transplant recipients. Assessing cellular immunity through interferon-gamma (IFN-γ) release assays, such as QuantiFERON®-CMV (QTF-CMV), is useful for guiding prophylactic and therapeutic decisions. Although ELISA is the validated method for QTF-CMV, chemiluminescence immunoassay (CLIA) may offer technical advantages. This study aimed to evaluate the performance of the CLIA-based LIAISON® QuantiFERON®-TB Gold Plus assay in quantifying IFN-γ in QTF-CMV testing, compared to the ELISA-based QuantiFERON®-CMV assay.
Methods
A retrospective study was conducted on 169 stored plasma samples from 85 lung transplant recipients. IFN-γ was quantified using both ELISA (Qiagen®) and CLIA (DiaSorin®). Specific (CMV-NIL) and nonspecific (MIT-NIL) responses were compared using Pearson and Lin's concordance correlation coefficients, Bland–Altman analysis, and ROC curves. Diagnostic agreement was assessed using the Kappa index, sensitivity, specificity, and agreement rates.
Results
CLIA yielded significantly higher IFN-γ values than ELISA for CMV-NIL (+0.41 IU/mL) and MIT-NIL (+0.33 IU/mL). Strong correlation and concordance were observed (r and ρc >0.93). Diagnostic agreement reached 95.86% (Kappa = 0.913), with fewer indeterminate results in CLIA (3.55% vs 4.73%). The optimal CLIA cut-off was 0.2754 IU/mL, achieving 100% sensitivity and specificity compared to ELISA.
Conclusions
CLIA shows excellent agreement with ELISA in QTF-CMV testing and is a reliable and automatable alternative. Its implementation may improve laboratory workflows. Adjusting the cut-off is recommended for optimal diagnostic accuracy.
扫码关注我们
求助内容:
应助结果提醒方式:
