Accuracy of VIDAS® TB-IGRA in TB patients and individuals with different thresholds of exposure

Delia Goletti; Niaz Banaei; Rahul Batra; Anne Emmanuelle Berger; Azra Blazevic; Elisabeth Botelho-Nevers; Ronan Breen; Natalie Bruiners; Emmanuelle Cambau; Etienne Carbonnelle; Charles L. Daley; Cécile Descotes-Genon; Francesco Di Gennaro; Florence Doucet-Populaire; Aliasgar Esmail; Julia Dolores Estrada Guzman; Luc Fontana; Maria Laura Gennaro; Deborah Handler; Rosa María Herrera Torres; Daniel Hoft; Nahed Ismail; Margaux Isnard; Julia Kenny; Alfred Lardizabal; François Xavier Lesage; Amanda Lopes; Williams Luciano López Vidal; Rene Machado Contreras; Philippe Manivet; Hubert Marotte; Frédéric Méchaï; Amel Medjahed-Artebasse; Richard Meldau; Yves Mérieux; Jacques Morel; Faiza Mougari; Suzette Oelofse; Fabrizio Palmieri; Jean Luc Perrot; Elisa Petruccioli; David T. Pride; Edouard Tuaillon; Caryn Upton; Naadira Vanker; Keertan Dheda

doi:10.1016/j.ijid.2025.108318

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Accuracy of VIDAS® TB-IGRA in TB patients and individuals with different thresholds of exposure

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Accuracy of VIDAS® TB-IGRA in TB patients and individuals with different thresholds of exposure

Delia Goletti, Niaz Banaei, Rahul Batra, Anne Emmanuelle Berger, Azra Blazevic, Elisabeth Botelho-Nevers, Ronan Breen, Natalie Bruiners, Emmanuelle Cambau, Etienne Carbonnelle, …

International journal of infectious diseases, p.108318

19/12/2025

DOI: https://doi.org/10.1016/j.ijid.2025.108318

PMID: 41422942

Résumé

Interferon gamma release assay

QFT®-Plus

sensitivity

specificity

Tuberculosis

VIDAS® TB-IGRA

•This study evaluated the recently developed VIDAS® TB-IGRA assay•VIDAS® TB-IGRA has higher sensitivity in TB disease than QuantiFERON®-TB Gold Plus•VIDAS® TB-IGRA shows high correlation between TB-exposure risk and positivity rate To achieve global TB control, more sensitive and user-friendly diagnostic tools for tuberculosis infection (TBI) are necessary, as it is a potential transmission reservoir. VIDAS® TB-IGRA (bioMérieux) is a fully automated assay recently developed. We report here the results of a global, multi-center, cross-sectional, prospective study to evaluate the diagnostic accuracy of the assay. Patients with TB disease (n=200) or participants at varying levels of TB exposure risk (n=1460; mixed TB-exposure risk population) were tested with both the VIDAS® TB-IGRA and the QuantiFERON®-TB Gold Plus (QFT®-Plus, QIAGEN). In culture-confirmed TB cases, VIDAS® TB-IGRA had a sensitivity significantly higher than QFT®-Plus (97.5% vs. 80.7%, p<0.0001). Specificity evaluated in blood donors from a low-prevalence country (n = 125) was high for both VIDAS® TB-IGRA and QFT®-Plus (97.6% [93.1-99.5] vs. 95.2% [89.8-98.2]; p=0.083), respectively. In the whole mixed TB-exposure risk population, negative (NPA) and positive percent agreement (PPA) were 90.1% (1097/1217) and 92.1% (223/242), respectively. However, regression analyses revealed that VIDAS® TB-IGRA correlated better with the TB-exposure risk gradient than QFT®‑Plus. Compared with QFT®-Plus, VIDAS® TB-IGRA was significantly more sensitive without a reduction in specificity, and it correlated better with an exposure gradient, suggesting that it is a valuable tool for TBI diagnosis. [Display omitted]

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Titre: Accuracy of VIDAS® TB-IGRA in TB patients and individuals with different thresholds of exposure
Créateurs - sans rôle: Delia Goletti - Translational Research Unit, National Institute for Infectious Diseases L. Spallanzani-IRCCS, Rome, Italy
Niaz Banaei - Stanford University School of Medicine, Stanford, CA, USA
Rahul Batra - Guy's and St Thomas' NHS Foundation Trust, London, UK
Anne Emmanuelle Berger - Laboratory of Immunology, University Hospital of Saint-Etienne, 42055, Saint-Etienne, France
Azra Blazevic - Saint Louis University School of Medicine, St. Louis, MO, USA
Elisabeth Botelho-Nevers - Infectious Diseases Department, University Hospital of Saint-Etienne, 42055, Saint-Etienne, France
Ronan Breen - Guy's and St Thomas' NHS Foundation Trust, London, UK
Natalie Bruiners - Public Health Research Institute, New Jersey Medical School, Rutgers University, Newark, NJ, USA
Emmanuelle Cambau - APHP-GHU Nord Bichat Hospital, Service de mycobacteriologie specialisee et de reference associate laboratory of the National reference center for mycobacteria
Etienne Carbonnelle - Department of microbiology, Avicenne Hospital, Bobigny, France
Charles L. Daley - Division of Mycobacterial and Respiratory Infections, National Jewish Health, Denver, CO, USA
Cécile Descotes-Genon - Department of Infectious Diseases, Centre Hospitalier de Chambéry, Chambéry, France
Francesco Di Gennaro - Respiratory Infectious Disease Unit Department, National Institute for Infectious Diseases L. Spallanzani-IRCCS, Rome, Italy
Florence Doucet-Populaire - Department of Bacteriology-Hygiene, APHP Université Paris-Saclay, Antoine Beclere Hospital, Clamart, France
Aliasgar Esmail - Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute & South African MRC/UCT Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa
Julia Dolores Estrada Guzman - Facultad de Medicina Mexicali, Universidad Autónoma de Baja California, 21000, Mexicali, BC, Mexico
Luc Fontana - Occupational and Environmental Health Department, University Hospital of Saint-Etienne, 42055, Saint-Etienne, France
Maria Laura Gennaro - Public Health Research Institute, New Jersey Medical School, Rutgers University, Newark, NJ, USA
Deborah Handler - Public Health Research Institute, New Jersey Medical School, Rutgers University, Newark, NJ, USA
Rosa María Herrera Torres - Autonomous University of Durango, Mexicali Campus
Daniel Hoft - Saint Louis University School of Medicine, St. Louis, MO, USA
Nahed Ismail - College of Medicine, University of Illinois at Chicago, Chicago, IL, USA
Margaux Isnard - Department of Infectious Diseases, Centre Hospitalier de Chambéry, Chambéry, France
Julia Kenny - Guy's and St Thomas' NHS Foundation Trust, London, UK
Alfred Lardizabal - Public Health Research Institute, New Jersey Medical School, Rutgers University, Newark, NJ, USA
François Xavier Lesage - Inserm
Amanda Lopes - APHP-GHU Nord Lariboisiere Hospital, Service de Medecine interne, 75010, Paris, France
Williams Luciano López Vidal - Facultad de Medicina Mexicali, Universidad Autónoma de Baja California, 21000, Mexicali, BC, Mexico
Rene Machado Contreras - Facultad de Medicina Mexicali, Universidad Autónoma de Baja California, 21000, Mexicali, BC, Mexico
Philippe Manivet - APHP GHU Nord Lariboisière Hospital, Centre de Ressources biologiques, 75010, Paris, France
Hubert Marotte - Université Jean Monnet, Rheumatology Department, CHU Saint-Etienne, INSERM, Mines Saint-Etienne, 42055, Saint-Etienne, France
Frédéric Méchaï - Department of infectious diseases, Avicenne Hospital, Hôpitaux universitaires Paris Seine-Saint-Denis, AP-HP, UFR SMBH, Université Sorbonne Paris Nord, Bobigny, France
Amel Medjahed-Artebasse - CLAT 92, Anti-TB center of Nanterre, Nanterre, France
Richard Meldau - Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute & South African MRC/UCT Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa
Yves Mérieux - Etablissement Français du Sang Auvergne-Rhône-Alpes, Lyon, France
Jacques Morel - Inserm
Faiza Mougari - Inserm
Suzette Oelofse - Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute & South African MRC/UCT Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa
Fabrizio Palmieri - Respiratory Infectious Disease Unit Department, National Institute for Infectious Diseases L. Spallanzani-IRCCS, Rome, Italy
Jean Luc Perrot - Dermatology Department, University Hospital of Saint-Etienne, 42055, Saint-Etienne, France
Elisa Petruccioli - Translational Research Unit, National Institute for Infectious Diseases L. Spallanzani-IRCCS, Rome, Italy
David T. Pride - University of California San Diego, La Jolla, CA, USA
Edouard Tuaillon - Pathogenesis and Control of Chronic and Emerging Infections, INSERM U1058, University of Montpellier, Montpellier University Hospital, Montpellier
Caryn Upton - TASK Applied Science, Cape Town, South Africa
Naadira Vanker - TASK Applied Science, Cape Town, South Africa
Keertan Dheda - Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute & South African MRC/UCT Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa
Détails de publication: International journal of infectious diseases, p.108318
Éditeur: Elsevier Ltd
Identifiants: 99148011109311
Unité académique: Pathogenesis and Control of Chronic and Emerging Infections - PCCEI; Institut Desbrest d Epidemiologie et de Sante Publique - IDESP
Langue: English
Type de ressource: Journal article