1 - Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2 - Dipartimento di Scienze biotecnologiche di base, cliniche intensivologiche e perioperatorie – Sezione di Microbiologia, Università Cattolica del Sacro Cuore, Milano, Italy
3 - Center for Global Health Research and Studies, Università Cattolica del Sacro Cuore, Roma, Italia
4 - Malalties Infeccioses i Resposta Inflamatòria Sistèmica en Pediatria, Unitat d’Infeccions, Servei de Pediatria, Institut de Recerca Sant Joan de Déu, Barcelona, Spain
5 - Departament de Pediatria, Universitat de Barcelona, Barcelona, Spain
6 - Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública, Madrid, Spain
7 - Red de Investigación Translacional en Infectología Pediátrica, Madrid, Spain
8 - Direzione Scientifica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
9 - Paediatric Infectious Diseases Department, Gregorio Marañón University Hospital, Madrid, Spain. Gregorio Marañón Research Health Institute (IiSGM), Madrid, Spain. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas {CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain
10 - Mycobacterial and Migrant Health Research Group, University of Basel Children’s Hospital Basel and Department of Clinical Research, University of Basel, Basel, Switzerland
11 - Paediatric Infectious Diseases Unit, Bambino Gesù Children Hospital, Rome, Italy
12 - Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité - Universitätsmedizin, Berlin, Germany
13 - Dipartimento di Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario "A. Gemelli", IRCCS, Rome, Italy
14 - Department of Translational Medical Sciences, Pediatric Infectious Diseases Unit, University of Naples Federico II, Naples, Italy
15 - Paediatric Infectious Diseases and Immunodeficiencies Unit, Hospital Universitari Vall d’Hebron, Barcelona, Spain
16 - Department of Pediatric Infectious Diseases, Erciyes University, Kayseri, Turkey
17 - Department of Paediatric Pulmonology, Children’s Hospital, Ruhr-University, Bochum, Germany
18 - Riga Stradiņš University, Riga, Latvia
19 - Hospital Infantil La Paz, Madrid, Spain
20 - CIBERINFEC, ISCIII, Madrid, Spain
21 - Panagiotis & Aglaia Kyriakou Children’s Hospital, Athens, Greece
22 - Hospital Dona Estefânia, Lisbon, Portugal
23 - Hospital Universitario Miguel Servet, Zaragoza, Spain
24 - Specialty School of Pediatrics, Alma Mater Studiorum, University of Bologna, Bologna, Italy
25 - St. Petersburg Scientific Research Institute of Phthisiopulmonology, St. Petersburg, Russian Federation
26 - Department of Paediatrics and Paediatric Infectious Diseases, Children’s Hospital Lucerne Lucerne Cantonal Hospital, Lucerne, Switzerland
27 - Department of Paediatrics, The University of Melbourne, The Royal Children’s Hospital Melbourne, Parkville, Victoria, Australia
28 - Medical University Sofia, Sofia, Bulgaria
29 - Paediatric Infectious Diseases Unit, St. George’s University Hospitals NHS Foundation Trust, London, UK
30 - Department of Paediatric and Adolescent Medicine, National Reference Centre for Childhood Tuberculosis, Klinik Ottakring, Vienna, Austria
31 - Ukraine. Department of Children Phthisiology, National Institution of Phthisiology and Pulmonology of National Academy of Medical sciences of Ukraine, Kiev, Ukraine
32 - Infectious diseases Centre «Clinic for treatment of children with HIV/AIDS» National Specialized Children’s Hospital ’OKHMATDYT’, Kiev, Ukraine
33 - Department of Infection, Immunity and Inflammation, UCL Great Ormond Street Institute of Child Health, University College London, London, UK
- Buonsenso D, et al. Thorax 2023;78:288–296
Rationale In 2016, a new interferon-gamma release assay (IGRA) was introduced, QuantiFERON-TB Gold Plus (QFT-Plus), claimed to have improved sensitivity in active tuberculosis (TB).
Objectives This study aimed to determine the performance of QFT-Plus, compared with previous generation IGRAs and the tuberculin skin test (TST), in children with TB in Europe.
Methods Multicentre, ambispective cohort study within the Paediatric Tuberculosis Network European Trials Group (ptbnet), a dedicated paediatric TB research network comprising >300 members, capturing TB cases <18 years-of-age diagnosed between January 2009 and December 2019.
Measurements and main results 1001 TB cases from 16 countries were included (mean age (IQR) 5.6 (2.4–12.1) years). QFT-Plus was performed in 358, QFT Gold in-Tube
(QFT-GIT) in 600, T-SPOT.TB in 58 and TST in 636 cases. The overall test sensitivities were: QFT-Plus 83.8% (95% CI 80.2% to 87.8%), QFT-GIT 85.5% (95% CI 82.7% to 88.3%), T-SPOT.TB 77.6% (95% CI 66.9% to 88.3%) and TST (cut-off ≥10 mm) 83.3% (95% CI 83.3% to 86.2%). There was a trend for tests to have lower sensitivity in patients with miliary and/or central nervous system (CNS) TB (73.1%, 70.9%, 63.6% and 43.5%, respectively), and in immunocompromised patients (75.0%, 59.6%, 45.5% and 59.1%, respectively).
Conclusions The results indicate that the latest generation IGRA assay, QFT-Plus, does not perform better than previous generation IGRAs or the TST in children with TB disease. Overall, tests performed worse in CNS and miliary TB, and in immunocompromised children. None of the tests evaluated had sufficiently high sensitivity to be used as a rule-out test in children with suspected TB.
Palavras Chave: Tuberculosis.