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Evaluation of the fully automated chemiluminescence analyzer Liaison XL for the performance of the QuantiFERON-TB Gold Plus assay in an area with a low incidence of tuberculosis
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Diagnosis of latent tuberculosis infection (LTBI) is considered key in the control of tuberculosis. Interferon gamma (IFN-g) release assays, such as the QuantiFERON-TB Gold Plus test (QFT-Plus), are now widely implemented for the in vitro diagnosis of LTBI. To date, the detection and quantification of IFN-g has been mostly performed with semiautomated enzyme-linked immunosorbent assays (ELISAs), but several limitations currently exist. The study aims to evaluate the chemiluminescence immunoassay (CLIA) analyzer Liaison XL compared to ELISA for the performance of the QFT-Plus test. Between February and April 2020, 333 heparin blood samples from 323 adult patients were collected at a tertiary teaching hospital in Barcelona, Spain. Overall, the CLIA analyzer Liaison XL performed well for the detection of IFN-g compared to the ELISA method, demonstrating substantial agreement (κ, 0.872) and great correlation between assays (r, .0.950). CLIA produced significantly higher values of IFN-g IU per milliliter than the ELISA (P = 0.004 for the TB1 tube and P = 0.010 for the TB2 tube). Many discrepant cases (8/15, 53.3%) corresponded to indeterminate results with ELISA (NIL-corrected mitogen value of ,0.5 IU/ml), which, when analyzed with the CLIA analyzer Liaison XL, reverted to interpretable results. In conclusion, this analysis suggests that CLIA presents a greater sensitivity for the identification of LTBI, especially among immunocompromised patients. Furthermore, the analytical variability reported between both ELISA and CLIA methods, especially around the standardized 0.35-IU/ml positivity threshold, suggests the need to refine the interpretative algorithm.
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FERNÁNDEZ-HUERTA, Miguel, MORETO, Clara, VILA-OLMO, Neus, GARCÍA DE CARA, Erika inés, BASAEZ, Celeste, SANTÍN CEREZALES, Miguel, ALCAIDE FERNÁNDEZ DE VEGA, Fernando. Evaluation of the fully automated chemiluminescence analyzer Liaison XL for the performance of the QuantiFERON-TB Gold Plus assay in an area with a low incidence of tuberculosis. _Journal of Clinical Microbiology_. 2021. Vol. 59, núm. 8, pàgs. e0060321. [consulta: 25 de febrer de 2026]. ISSN: 0095-1137. [Disponible a: https://hdl.handle.net/2445/186050]