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Diagnostic accuracy and predictive value of the QuantiFERON-TB gold plus assay for tuberculosis in immunocompromised individuals: a prospective TBnet study

2025-08-06Artigo científico Acesso aberto
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dc.contributor.authorSester, Martina
dc.contributor.authorAltet-Gomez, Neus
dc.contributor.authorAndersen, Åse Bengaard
dc.contributor.authorArias-Guillén, Miguel
dc.contributor.authorAvsar, Korkut
dc.contributor.authorBakken Kran, Anne-Marte
dc.contributor.authorBothamley, Graham
dc.contributor.authorNordholm Breschel, Anne Christine
dc.contributor.authorBrown, James
dc.contributor.authorChesov, Dumitru
dc.contributor.authorCiobanu, Nelly
dc.contributor.authorCirillo, Daniela Maria
dc.contributor.authorCrudu, Valeriu
dc.contributor.authorde Souza Galvao, Malu
dc.contributor.authorDilektasli, Asli Görek
dc.contributor.authorDominguez, José
dc.contributor.authorDuarte, Raquel
dc.contributor.authorDyrhol-Riise, Anne Ma
dc.contributor.authorGoletti, Delia
dc.contributor.authorHoffmann, Harald
dc.contributor.authorIbraim, Elmira
dc.contributor.authorKalsdorf, Barbara
dc.contributor.authorKrawczyk, Marcin
dc.contributor.authorKunst, Heinke
dc.contributor.authorLange, Berit
dc.contributor.authorLipman, Marc
dc.contributor.authorMatteelli, Alberto
dc.contributor.authorMilkiewicz, Piotr
dc.contributor.authorNeyer, David
dc.contributor.authorNitschke, Martin
dc.contributor.authorOral, Haluk Barbaros
dc.contributor.authorPalacios-Gutiérrez, Juan José
dc.contributor.authorPetruccioli, Elisa
dc.contributor.authorRaszeja-Wyszomirska, Joanna
dc.contributor.authorRavn, Pernille
dc.contributor.authorRupp, Jan
dc.contributor.authorSpohn, Hanna-Elisa
dc.contributor.authorToader, Corina
dc.contributor.authorVillar-Hernandez, Raquel
dc.contributor.authorWagner, Dirk
dc.contributor.authorvan Leth, Frank
dc.contributor.authorMartinez, Leonardo
dc.contributor.authorPedersen, Ole Skouvig
dc.contributor.authorLange, Christoph
dc.date.accessioned2026-02-13T15:15:23Z
dc.date.available2026-02-13T15:15:23Z
dc.date.issued2025-08-06
dc.descriptionErratum in: Lancet Reg Health Eur. 2025 Nov 26;59:101523. doi: 10.1016/j.lanepe.2025.101523. eCollection 2025 Dec.
dc.description.abstractBackground: In low tuberculosis (TB)-endemic countries, tuberculosis preventive therapy (TPT) is recommended for immunocompromised individuals with a positive immunodiagnostic test. This study aimed to assess the performance of the QuantiFERON-TB Gold Plus (QFT+) assay and predictive power for future tuberculosis in immunocompromised individuals. Methods: In this prospective observational study, immunocompromised adults ≥18 years of age including people living with HIV (PLHIV), chronic renal failure, rheumatoid arthritis, solid-organ transplantation or stem-cell transplantation, and immunocompetent adults with and without TB-disease were recruited at 21 sites in 11 European countries and tested with the QFT+ assay. Individuals without TB-disease were followed up for the development of tuberculosis. TB incidence rates (IR) were calculated, stratified by QFT+ results and acceptance of TPT. This study is registered with Clinicaltrials.gov, NCT02639936. Findings: A total of 2663 individuals (1115 female, 1548 male) were enrolled from 03/11/2015 to 29/03/2019. Persons without tuberculosis were followed up for at least two years. Among 1758 immunocompromised individuals without active tuberculosis, 13.6% had positive QFT+ results. Sensitivity and specificity for TB-disease were 70.0% (52.1-83.3%) and 91.4% (89.6-92.9%), respectively, in immunocompromised, and 81.4% (76.6-85.3%) and 96.0% (92.5-97.9%), respectively, in immunocompetent individuals. During 2457 cumulative years of follow-up among 932 individuals with chronic renal failure, rheumatoid arthritis, solid-organ transplantation or stem-cell transplantation, including 83 persons with a positive QFT+ test without TPT, no-one developed active tuberculosis. In contrast, among 642 PLHIV without TPT, one with an indeterminate QFT+ and 3/30 individuals with a positive QFT+ developed active tuberculosis; all had detectable HIV-replication and low CD4 T-cell counts (incidence 4.1 (95% CI (1.3-12.4) per 100 person-years). No individuals receiving TPT developed active tuberculosis during 269 years of follow-up. Interpretation: In immunocompromised individuals in low TB-endemic countries, the 2-year-risk for active tuberculosis was highest among PLHIV with detectable HIV-replication and low CD4-counts. In this study, the QFT+ assay did not strongly predict progression to active tuberculosis, which emphasises the need to incorporate additional risk factors.eng
dc.identifier.citationLancet Reg Health Eur. 2025 Aug 6:57:101416. doi: 10.1016/j.lanepe.2025.101416. eCollection 2025 Oct
dc.identifier.doi10.1016/j.lanepe.2025.101416
dc.identifier.issn2666-7762
dc.identifier.pmid40823191
dc.identifier.urihttp://hdl.handle.net/10400.18/10935
dc.language.isoeng
dc.peerreviewedyes
dc.publisherElsevier
dc.relation.hasversionhttps://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(25)00208-X/fulltext
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectIGRA
dc.subjectProgression to Tuberculosis
dc.subjectTuberculosis
dc.subjectTBnet
dc.subjectImmunocompromised Individuals
dc.subjectInfecções Respiratórias
dc.subjectCuidados de Saúde
dc.titleDiagnostic accuracy and predictive value of the QuantiFERON-TB gold plus assay for tuberculosis in immunocompromised individuals: a prospective TBnet studyeng
dc.typejournal article
dcterms.referenceshttps://ars.els-cdn.com/content/image/1-s2.0-S266677622500208X-mmc1.docx
dspace.entity.typePublication
oaire.citation.startPage101416
oaire.citation.titleThe Lancet Regional Health Europe
oaire.citation.volume57
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

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