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
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...
| Autores: | , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión aceptada para publicación |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | Universidad de Barcelona |
| Repositorio: | Dipòsit Digital de la UB |
| OAI Identifier: | oai:diposit.ub.edu:2445/186050 |
| Acceso en línea: | https://hdl.handle.net/2445/186050 |
| Access Level: | acceso abierto |
| Palabra clave: | Tuberculosi Anàlisi de sang Luminescència Interferó Tuberculosis Analysis of blood Luminescence Interferon |
| Sumario: | 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. |
|---|