Evidence map›Paper›PMID 40823191›Full record

ArticleThe Lancet regional health. Europe2025

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

Martina Sester, Neus Altet-Gomez, Åse Bengaard Andersen, Miguel Arias-Guillén, Korkut Avsar, Anne-Marte Bakken Kran, Graham Bothamley, Anne Christine Nordholm Breschel, James Brown, Dumitru Chesov and 34 more

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in The Lancet regional health. Europe, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02639936 (Performance of a New Generation IGRA in Immunocompromised Individuals), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02639936 completednot on this map

Performance of a New Generation IGRA in Immunocompromised Individuals

TypeobservationalSponsorTuberculosis Network European TrialsgroupRan2015 to 2023Enrolled2,663ConditionsMonitoring, Immunologic, Active Tuberculosis, Tuberculosis in Solid Organ Transplant Recipients, Tuberculosis in Marrow Transplant Recipients
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

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  11. Biliary microbiota in disease-free, obstructive and post-drainage biliary tracts.Frontiers in cellular and infection microbiology · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

44 authors.

Martina SesterDepartment of Transplant and Infection Immunology, Saarland University, Homburg, Germany.
Neus Altet-GomezUnidad Clinica de Tratamiento. Directamente Observado "Serveis Clinics", Barcelona, Spain.
Åse Bengaard AndersenDepartment of Infectious Diseases, Odense University Hospital, Odense, Denmark.
Miguel Arias-GuillénRespiratory Department, Central University Hospital of Asturias, ISPA, Faculty of Medicine, University of Oviedo, CIBER-Respiratory Diseases, Carlos III Health Institute, Oviedo, Spain.
Korkut AvsarDepartment of Infectious Diseases, Asklepios Fachklinik München-Gauting, Munich, Germany.
Anne-Marte Bakken KranDivision of Infection Control, Norwegian Institute of Public Health (NIPH), Oslo, Norway.
Graham BothamleyHomerton University Hospital, London, UK.
Anne Christine Nordholm BreschelDepartment of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Copenhagen, Denmark.
James BrownDepartment of Respiratory Medicine, Royal Free London NHS Trust and UCL Respiratory, University College London, UK.
Dumitru ChesovDiscipline of Pneumology and Allergology Nicolae Testemitanu State University of Medicine and Pharmacy, Republic of Moldova.
Nelly CiobanuNational TB Reference Laboratory, Pneumology Institute, Chisinau, Moldova.
Daniela Maria CirilloIRCCS San Raffaele Scientific Institute, Milan, Italy.
Valeriu CruduNational TB Reference Laboratory, Pneumology Institute, Chisinau, Moldova.
Malu de Souza GalvaoPneumology Service, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Asli Görek DilektasliDepartment of Pulmonary Medicine, Bursa Uludag University Faculty of Medicine, Bursa, Turkey.
José DominguezServei de Microbiologia, Hospital Universitari Germans Trias i Pujol, Institut d'Investigació Germans Trias i Pujol, Badalona, Spain.
Raquel DuarteInstituto Nacional De Saúde Dr Ricardo Jorge do Porto, Porto, Portugal.
Anne Ma Dyrhol-RiiseDepartment of Infectious Diseases, Oslo University Hospital, Oslo, Norway.
Delia GolettiTranslational Research Unit, National Institute for Infectious Diseases "Lazzaro Spallanzani", Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
Harald HoffmannInstitute of Microbiology and Laboratory Medicine, IML red GmbH; WHO - Supranational Tuberculosis Reference Laboratory Munch-Gauting; Gauting, Germany.
Elmira IbraimDepartment of Clinical Research, Marius Nasta Institute of Pneumophtiziology, Bucharest, Romania.
Barbara KalsdorfClinical Infectious Disease. Department of Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center, Borstel, Germany.
Marcin KrawczykDepartment of Gastroenterology, Hepatology and Transplant Medicine, Medical Faculty, University of Duisburg-Essen, Essen, Germany.
Heinke KunstQueen Mary & Barts Health Tuberculosis Centre, Blizard Institute, Faculty of Medicine & Dentistry, Queen Mary University of London, London, UK.
Berit LangeDepartment of Epidemiology, Helmholtz Centre for Infection Research (HZI), Braunschweig, Germany.
Marc LipmanDepartment of Respiratory Medicine, Royal Free London NHS Trust and UCL Respiratory, University College London, UK.
Alberto MatteelliClinic of Infectious and Tropical Diseases, Department of Clinical and Experimental Medicine, WHO Collaboration Centre for Tuberculosis Prevention, University of Brescia, Brescia, Italy.
Piotr MilkiewiczDepartment of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland.
David NeyerDivision of Infectious Diseases, Department of Internal Medicine II, Freiburg University Medical Centre, Freiburg, Germany.
Martin NitschkeTransplant Center, University Hospital of Schleswig-Holstein, Lübeck, Germany.
Haluk Barbaros OralDepartment of Immunology, Faculty of Medicine, Bursa Uludag University, Bursa, Turkey.
Juan José Palacios-GutiérrezRegional Mycobacteria Reference Unit, Central University Hospital of Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.
Elisa PetruccioliInstituto de Saúde Pública da Universidade do Porto; Porto, Portugal.
Joanna Raszeja-WyszomirskaDepartment of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland.
Pernille RavnSection of Infectious Diseases, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Denmark.
Jan RuppInfectious Disease Clinic and Institute of Medical Microbiology, University Hospital Schleswig-Holstein, Lübeck, Germany.
Hanna-Elisa SpohnDepartment of Transplant and Infection Immunology, Saarland University, Homburg, Germany.
Corina ToaderPathology Department, Marius Nasta Institute of Pneumophysiology, Bucharest, Romania.
Raquel Villar-HernandezServei de Microbiologia, Hospital Universitari Germans Trias i Pujol, Institut d'Investigació Germans Trias i Pujol, Badalona, Spain.
Dirk WagnerDepartment of Epidemiology, Helmholtz Centre for Infection Research (HZI), Braunschweig, Germany.
Frank van LethDepartment of Health Sciences, Vrij Universiteit Amsterdam, the Netherlands.
Leonardo MartinezBoston University, School of Public Health, Department of Epidemiology, Boston, MA, USA.
Ole Skouvig PedersenDepartment of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.
Christoph LangeClinical Infectious Disease. Department of Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center, Borstel, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: 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. Funding: None.

Indexed as

IGRAImmunocompromised individualsProgression to tuberculosisTBnetTuberculosis

Identifiers

PMID40823191
PMCPMC12355092

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Registered trials

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