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

Martina Sester^{1

2}, Neus Altet-Gomez³, Åse Bengaard Andersen⁴, Miguel Arias-Guillén⁵, Korkut Avsar⁶, Anne-Marte Bakken Kran⁷, Graham Bothamley^{8

9

10}, Anne Christine Nordholm Breschel^{11

12}, James Brown¹³, Dumitru Chesov^{14

15

16}, Nelly Ciobanu¹⁷, Daniela Maria Cirillo¹⁸, Valeriu Crudu¹⁷, Malu de Souza Galvao¹⁹, Asli Görek Dilektasli²⁰, José Dominguez^{21

22

23}, Raquel Duarte^{24

25}, Anne Ma Dyrhol-Riise^{26

27}, Delia Goletti²⁸, Harald Hoffmann^{29

30}, Elmira Ibraim³¹, Barbara Kalsdorf^{15

16

32}, Marcin Krawczyk^{33

34}, Heinke Kunst³⁵, Berit Lange^{36

37}, Marc Lipman¹³, Alberto Matteelli³⁸, Piotr Milkiewicz^{39

40}, David Neyer⁴¹, Martin Nitschke⁴², Haluk Barbaros Oral⁴³, Juan José Palacios-Gutiérrez⁴⁴, Elisa Petruccioli²⁵, Joanna Raszeja-Wyszomirska³⁹, Pernille Ravn⁴⁵, Jan Rupp^{46

47}, Hanna-Elisa Spohn¹, Corina Toader⁴⁸, Raquel Villar-Hernandez²¹, Dirk Wagner^{36

41}, Frank van Leth^{49

50}, Leonardo Martinez⁵¹, Ole Skouvig Pedersen^{52

53}, Christoph Lange^{15

16

31

54}

Affiliations

¹ Department of Transplant and Infection Immunology, Saarland University, Homburg, Germany.
² Center for Gender-specific Biology and Medicine (CGBM), Saarland University, Homburg, Germany.
³ Unidad Clinica de Tratamiento. Directamente Observado "Serveis Clinics", Barcelona, Spain.
⁴ Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.
⁵ Respiratory Department, Central University Hospital of Asturias, ISPA, Faculty of Medicine, University of Oviedo, CIBER-Respiratory Diseases, Carlos III Health Institute, Oviedo, Spain.
⁶ Department of Infectious Diseases, Asklepios Fachklinik München-Gauting, Munich, Germany.
⁷ Division of Infection Control, Norwegian Institute of Public Health (NIPH), Oslo, Norway.
⁸ Homerton University Hospital, London, UK.
⁹ Queen Mary University of London, London, UK.
¹⁰ London School of Hygiene and Tropical Medicine, London, UK.
¹¹ Department of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Copenhagen, Denmark.
¹² Department of Infectious Diseases, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
¹³ Department of Respiratory Medicine, Royal Free London NHS Trust and UCL Respiratory, University College London, UK.
¹⁴ Discipline of Pneumology and Allergology Nicolae Testemitanu State University of Medicine and Pharmacy, Republic of Moldova.
¹⁵ Clinical Infectious Disease. Department of Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center, Borstel, Germany.
¹⁶ German Center for Infection Research (DZIF), Tuberculosis Unit, Borstel, Germany.
¹⁷ National TB Reference Laboratory, Pneumology Institute, Chisinau, Moldova.
¹⁸ IRCCS San Raffaele Scientific Institute, Milan, Italy.
¹⁹ Pneumology Service, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
²⁰ Department of Pulmonary Medicine, Bursa Uludag University Faculty of Medicine, Bursa, Turkey.
²¹ Servei de Microbiologia, Hospital Universitari Germans Trias i Pujol, Institut d'Investigació Germans Trias i Pujol, Badalona, Spain.
²² CIBER Enfermedades Respiratorias, Badalona, Spain.
²³ Universidad Autónoma de Barcelona, Barcelona, Spain.
²⁴ Instituto Nacional De Saúde Dr Ricardo Jorge do Porto, Porto, Portugal.
²⁵ Instituto de Saúde Pública da Universidade do Porto; Porto, Portugal.
²⁶ Department of Infectious Diseases, Oslo University Hospital, Oslo, Norway.
²⁷ Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
²⁸ Translational Research Unit, National Institute for Infectious Diseases "Lazzaro Spallanzani", Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
²⁹ Institute of Microbiology and Laboratory Medicine, IML red GmbH; WHO - Supranational Tuberculosis Reference Laboratory Munch-Gauting; Gauting, Germany.
³⁰ SYNLAB Gauting, SYNLAB MVZ Dachau GmbH, Munich-Gauting, Germany.
³¹ Department of Clinical Research, Marius Nasta Institute of Pneumophtiziology, Bucharest, Romania.
³² Respiratory Medicine & International Health, University of Lübeck, Lübeck, Germany.
³³ Department of Gastroenterology, Hepatology and Transplant Medicine, Medical Faculty, University of Duisburg-Essen, Essen, Germany.
³⁴ Laboratory of Metabolic Liver Diseases, Department of General, Transplant and Liver Surgery, Centre for Preclinical Research, Medical University of Warsaw, Warsaw, Poland.
³⁵ Queen Mary & Barts Health Tuberculosis Centre, Blizard Institute, Faculty of Medicine & Dentistry, Queen Mary University of London, London, UK.
³⁶ Department of Epidemiology, Helmholtz Centre for Infection Research (HZI), Braunschweig, Germany.
³⁷ German Center for Infection Research (DZIF), Braunschweig, Germany.
³⁸ Clinic of Infectious and Tropical Diseases, Department of Clinical and Experimental Medicine, WHO Collaboration Centre for Tuberculosis Prevention, University of Brescia, Brescia, Italy.
³⁹ Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland.
⁴⁰ Translational Medicine Group, Pomeranian Medical University, Szczecin, Poland.
⁴¹ Division of Infectious Diseases, Department of Internal Medicine II, Freiburg University Medical Centre, Freiburg, Germany.
⁴² Transplant Center, University Hospital of Schleswig-Holstein, Lübeck, Germany.
⁴³ Department of Immunology, Faculty of Medicine, Bursa Uludag University, Bursa, Turkey.
⁴⁴ Regional Mycobacteria Reference Unit, Central University Hospital of Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.
⁴⁵ Section of Infectious Diseases, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Denmark.
⁴⁶ Infectious Disease Clinic and Institute of Medical Microbiology, University Hospital Schleswig-Holstein, Lübeck, Germany.
⁴⁷ German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Borstel-Riems, Lübeck, Germany.
⁴⁸ Pathology Department, Marius Nasta Institute of Pneumophysiology, Bucharest, Romania.
⁴⁹ Department of Health Sciences, Vrij Universiteit Amsterdam, the Netherlands.
⁵⁰ Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.
⁵¹ Boston University, School of Public Health, Department of Epidemiology, Boston, MA, USA.
⁵² Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.
⁵³ Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
⁵⁴ Global TB Program, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.

PMID: 40823191
PMCID: PMC12355092
DOI: 10.1016/j.lanepe.2025.101416

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

Martina Sester et al. Lancet Reg Health Eur. 2025.

. 2025 Aug 6:57:101416.

doi: 10.1016/j.lanepe.2025.101416. eCollection 2025 Oct.

Authors

Affiliations

¹ Department of Transplant and Infection Immunology, Saarland University, Homburg, Germany.
² Center for Gender-specific Biology and Medicine (CGBM), Saarland University, Homburg, Germany.
³ Unidad Clinica de Tratamiento. Directamente Observado "Serveis Clinics", Barcelona, Spain.
⁴ Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.
⁵ Respiratory Department, Central University Hospital of Asturias, ISPA, Faculty of Medicine, University of Oviedo, CIBER-Respiratory Diseases, Carlos III Health Institute, Oviedo, Spain.
⁶ Department of Infectious Diseases, Asklepios Fachklinik München-Gauting, Munich, Germany.
⁷ Division of Infection Control, Norwegian Institute of Public Health (NIPH), Oslo, Norway.
⁸ Homerton University Hospital, London, UK.
⁹ Queen Mary University of London, London, UK.
¹⁰ London School of Hygiene and Tropical Medicine, London, UK.
¹¹ Department of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Copenhagen, Denmark.
¹² Department of Infectious Diseases, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
¹³ Department of Respiratory Medicine, Royal Free London NHS Trust and UCL Respiratory, University College London, UK.
¹⁴ Discipline of Pneumology and Allergology Nicolae Testemitanu State University of Medicine and Pharmacy, Republic of Moldova.
¹⁵ Clinical Infectious Disease. Department of Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center, Borstel, Germany.
¹⁶ German Center for Infection Research (DZIF), Tuberculosis Unit, Borstel, Germany.
¹⁷ National TB Reference Laboratory, Pneumology Institute, Chisinau, Moldova.
¹⁸ IRCCS San Raffaele Scientific Institute, Milan, Italy.
¹⁹ Pneumology Service, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
²⁰ Department of Pulmonary Medicine, Bursa Uludag University Faculty of Medicine, Bursa, Turkey.
²¹ Servei de Microbiologia, Hospital Universitari Germans Trias i Pujol, Institut d'Investigació Germans Trias i Pujol, Badalona, Spain.
²² CIBER Enfermedades Respiratorias, Badalona, Spain.
²³ Universidad Autónoma de Barcelona, Barcelona, Spain.
²⁴ Instituto Nacional De Saúde Dr Ricardo Jorge do Porto, Porto, Portugal.
²⁵ Instituto de Saúde Pública da Universidade do Porto; Porto, Portugal.
²⁶ Department of Infectious Diseases, Oslo University Hospital, Oslo, Norway.
²⁷ Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
²⁸ Translational Research Unit, National Institute for Infectious Diseases "Lazzaro Spallanzani", Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
²⁹ Institute of Microbiology and Laboratory Medicine, IML red GmbH; WHO - Supranational Tuberculosis Reference Laboratory Munch-Gauting; Gauting, Germany.
³⁰ SYNLAB Gauting, SYNLAB MVZ Dachau GmbH, Munich-Gauting, Germany.
³¹ Department of Clinical Research, Marius Nasta Institute of Pneumophtiziology, Bucharest, Romania.
³² Respiratory Medicine & International Health, University of Lübeck, Lübeck, Germany.
³³ Department of Gastroenterology, Hepatology and Transplant Medicine, Medical Faculty, University of Duisburg-Essen, Essen, Germany.
³⁴ Laboratory of Metabolic Liver Diseases, Department of General, Transplant and Liver Surgery, Centre for Preclinical Research, Medical University of Warsaw, Warsaw, Poland.
³⁵ Queen Mary & Barts Health Tuberculosis Centre, Blizard Institute, Faculty of Medicine & Dentistry, Queen Mary University of London, London, UK.
³⁶ Department of Epidemiology, Helmholtz Centre for Infection Research (HZI), Braunschweig, Germany.
³⁷ German Center for Infection Research (DZIF), Braunschweig, Germany.
³⁸ Clinic of Infectious and Tropical Diseases, Department of Clinical and Experimental Medicine, WHO Collaboration Centre for Tuberculosis Prevention, University of Brescia, Brescia, Italy.
³⁹ Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland.
⁴⁰ Translational Medicine Group, Pomeranian Medical University, Szczecin, Poland.
⁴¹ Division of Infectious Diseases, Department of Internal Medicine II, Freiburg University Medical Centre, Freiburg, Germany.
⁴² Transplant Center, University Hospital of Schleswig-Holstein, Lübeck, Germany.
⁴³ Department of Immunology, Faculty of Medicine, Bursa Uludag University, Bursa, Turkey.
⁴⁴ Regional Mycobacteria Reference Unit, Central University Hospital of Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.
⁴⁵ Section of Infectious Diseases, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Denmark.
⁴⁶ Infectious Disease Clinic and Institute of Medical Microbiology, University Hospital Schleswig-Holstein, Lübeck, Germany.
⁴⁷ German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Borstel-Riems, Lübeck, Germany.
⁴⁸ Pathology Department, Marius Nasta Institute of Pneumophysiology, Bucharest, Romania.
⁴⁹ Department of Health Sciences, Vrij Universiteit Amsterdam, the Netherlands.
⁵⁰ Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.
⁵¹ Boston University, School of Public Health, Department of Epidemiology, Boston, MA, USA.
⁵² Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.
⁵³ Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
⁵⁴ Global TB Program, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.

PMID: 40823191
PMCID: PMC12355092
DOI: 10.1016/j.lanepe.2025.101416

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.

Keywords: IGRA; Immunocompromised individuals; Progression to tuberculosis; TBnet; Tuberculosis.

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Conflict of interest statement

Aase Bengaard Andersen has a patent regarding ESAT-6 for use in Quantiferon test issued via Statens Serum Institute and sold more than 10 years ago, and is chairman of Data Safety Monitoring Board regarding phase 1 vaccine study sponsored by Statens Serum Institute (nTB-01) finalized in December 2024. Graham Bothamley reports to have been past chair of TBnet. James Brown has received a grant from Asthma + Lung UK for a project investigating serological diagnosis of mycobacterium avium lung disease, paid to the institution. Delia Goletti has received consulting fees by PBD Biotech to participate at a scientific board, and a honorarium by Biomerieux for a presentation. Harald Hoffmann has received consulting fees, expert testimonies, and travel fees by USAID, the German government (KfW and BMZ), the global Fund, UNDP, and GIZ. Barbara Kalsdorf has received honoraria for lectures and/or support for meetings and travel by Insmed Germany GmbH, AstraZeneca, Chiesi, Boehringer Ingelheim, and Grifols. Berit Lange has received grant support by the German BMG and BMBF, has received honoraria from Freiburg University for a presentation, and has received support for attending meetings by Roche, MSD, Janssen Cilag, and Abbott, and declares membership of several boards (Expert Council ‘Health and Resilience’, Federal Chancellery, Standing Vaccination Commission at the Robert Koch Institute, Elected (Deputy) President of the German Society for Epidemiology (DGEpi), deputy in 2023 and 2026, president in 2024 and 2025; Part of the pool of experts of the Federal Ministry of Education and Research (BMBF) for consultations on pandemic preparedness and the overall responsiveness of health research to health crises; Member of the Advisory Board for the Pact for Public Health (Pakt ÖGD), Federal Ministry of Health (BMG); Elected Speaker of the Modelling Network for Severe Infectious Diseases in Germany (MONID); Member of the DZIF Internal Advisory Board; Elected member of the steering committee of TBnet; Member of the Working group “Sounding Board Prioritization List” of the National Vaccination Committee of the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (Austria)). Christoph Lange is supported by the German Center of Infection Research, and has received consulting fees and honoraria from Insmed Germany GmbH, Gilead, AstraZeneca, or GSK, and is a member of the Data Safety Board of trials from Medicines sans Frontiers. Marc Lipman is an unpaid trustee of the NTM Network UK, of NTM patient care UK, and Chair of the UK Joint Tuberculosis Committee. Martin Nitschke has received honoraria for lectures by AstraZeneca, Boehringer Ingelheim, travel support by Lilly, and participated in Data Safety Monitoring Boards for AstraZeneca and Boehringer Ingelheim. Pernille Ravn has received honoraria by Takeda for lectures, and has a patent on IP-10 as TB diagnostic agent, and has received Quantiferon kits from SSI Diagnostics for research purposes. Martina Sester and TBnet have received QuantiFERON kits for the present study free of charge. Martina Sester has received grant support by Astellas, Biotest, and Takeda to the institution Saarland University outside of the submitted work, and has received honoraria for presentations or work in Data Safety monitoring Boards, and travel support for meetings by Biotest, Novartis, Takeda, MSD, and Moderna. Dirk Wagner has participated in an advisory board by Pfizer on NTM-PD. All other authors do not have any conflict of interest to declare.

Figures

**Fig. 1**
**Study design including timeline of patient enrollment for baseline analyses and follow-up for incident tuberculosis. (a)** In the cross-sectional part of the study, all participants underwent QFT+ testing at individual sites. QFT+ results, along with demographic and clinical characteristics including risk factors for *Mycobacterium tuberculosis* exposure were collected using a standardised questionnaire. Active tuberculosis at the time of QFT+ testing was defined by nucleic acid amplification test positivity and/or culture confirmation. The diagnostic accuracy of QFT+ for detecting active tuberculosis at baseline (sensitivity and specificity) was assessed in this part of the study (part A). Tuberculosis preventive therapy (TPT) was administered according to individual site practice, at the discretion of the treating physicians. **(b)** Part B of the study prospectively assessed the progression to incident active tuberculosis, stratified by baseline QFT+ result. All individuals without tuberculosis at baseline were subsequently followed for at least two years after enrolment or until the development of incident tuberculosis or censoring (date when patients had their last clinical assessment, died, or at the end of study, whichever occurred first). Horizontal lines represent examples of individual persons with variable observation times for follow-up. The median duration of follow-up was 2.6 (interquartile range 2.1–3.4) years.

**Fig. 2**
**Flow chart of immunocompromised individuals and controls recruited into the study and cases of active tuberculosis during follow-up and results of immune-based testing. (a)** The number of individuals analysed at baseline in the cross-sectional study, and the number of individuals who were included to assess development of tuberculosis on follow-up (incident cases). All individuals with more than 30 days of follow-up were included, with the number of individuals and cumulative person-years of follow-up indicated for each group. HIV, human immunodeficiency virus infection. The percentage of positive QFT+ test-results among immunocompromised individuals and immunocompetent controls without tuberculosis **(b)** without and **(c)** with risk-factors for *M. tuberculosis*, and in **(d)** immunocompromised individuals and immunocompetent controls with tuberculosis was quantified. Qualitative results (positive and negative) are shown for the QFT+ assay as well as separately for tube 1 and tube 2; statistical analysis was carried out using McNemar's test for matched samples; percentages of positive, negative and indeterminate test results for each group are given in Table 1. HIV, human immunodeficiency virus infection; CRF, chronic renal failure; IC, immunocompromised; PY, person-year; RA, rheumatoid arthritis; SOT, solid-organ transplantation; SCT, stem-cell transplantation; TB, tuberculosis.

**Fig. 3**
**Time to progression to tuberculosis**. Shown are all participants without tuberculosis preventive therapy (TPT) stratified according to **(a)** QFT+ results, **(b)** QFT+ results and HIV-status. PLHIV were stratified by **(c)** HIV-load, **(d)** HIV-load and QFT+ result, **(e)** HIV-load and CD4-counts, or **(f)** HIV-load and tuberculosis incidence in the country of origin; this analysis was restricted to individuals with positive or negative QFT+ results; the curves were based on the Aalen-Johansen estimator considering death as a competing risk; Comparisons between groups were carried out using Gray's test for equivalence of cumulative incidence function; numbers of individuals at risk are summarised in Supplementary Table S6.

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References

1. World Health Organization . 2024. Global tuberculosis report 2023. Geneva, Switzerland.
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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials