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...

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Autores: Fernández-Huerta, Miguel, Moreto, Clara, Vila-Olmo, Neus, García de Cara, Erika Inés, Basaez, Celeste, Santín Cerezales, Miguel, Alcaide Fernández de Vega, Fernando
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
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spelling 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 tuberculosisFernández-Huerta, MiguelMoreto, ClaraVila-Olmo, NeusGarcía de Cara, Erika InésBasaez, CelesteSantín Cerezales, MiguelAlcaide Fernández de Vega, FernandoTuberculosiAnàlisi de sangLuminescènciaInterferóTuberculosisAnalysis of bloodLuminescenceInterferonDiagnosis 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.American Society for Microbiology2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersionapplication/pdfhttps://hdl.handle.net/2445/186050Articles publicats en revistes (Patologia i Terapèutica Experimental)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésVersió postprint del document publicat a: https://doi.org/10.1128/JCM.00603-21Journal of Clinical Microbiology, 2021, vol. 59, num. 8, p. e0060321https://doi.org/10.1128/JCM.00603-21(c) American Society for Microbiology, 2021info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1860502026-05-27T06:46:51Z
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Fernández-Huerta, Miguel
Tuberculosi
Anàlisi de sang
Luminescència
Interferó
Tuberculosis
Analysis of blood
Luminescence
Interferon
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Fernández-Huerta, Miguel
Moreto, Clara
Vila-Olmo, Neus
García de Cara, Erika Inés
Basaez, Celeste
Santín Cerezales, Miguel
Alcaide Fernández de Vega, Fernando
author Fernández-Huerta, Miguel
author_facet Fernández-Huerta, Miguel
Moreto, Clara
Vila-Olmo, Neus
García de Cara, Erika Inés
Basaez, Celeste
Santín Cerezales, Miguel
Alcaide Fernández de Vega, Fernando
author_role author
author2 Moreto, Clara
Vila-Olmo, Neus
García de Cara, Erika Inés
Basaez, Celeste
Santín Cerezales, Miguel
Alcaide Fernández de Vega, Fernando
author2_role author
author
author
author
author
author
dc.subject.none.fl_str_mv Tuberculosi
Anàlisi de sang
Luminescència
Interferó
Tuberculosis
Analysis of blood
Luminescence
Interferon
topic Tuberculosi
Anàlisi de sang
Luminescència
Interferó
Tuberculosis
Analysis of blood
Luminescence
Interferon
description 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.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
format article
status_str acceptedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/186050
url https://hdl.handle.net/2445/186050
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Versió postprint del document publicat a: https://doi.org/10.1128/JCM.00603-21
Journal of Clinical Microbiology, 2021, vol. 59, num. 8, p. e0060321
https://doi.org/10.1128/JCM.00603-21
dc.rights.none.fl_str_mv (c) American Society for Microbiology, 2021
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) American Society for Microbiology, 2021
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv American Society for Microbiology
publisher.none.fl_str_mv American Society for Microbiology
dc.source.none.fl_str_mv Articles publicats en revistes (Patologia i Terapèutica Experimental)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869416297388834817
score 15,301603

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