Performance of QuantiFERON-TB Gold Plus assays in paediatric tuberculosis: a multicentre PTBNET study.

Autor:	Buonsenso D; Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.; Dipartimento di Scienze biotecnologiche di base, cliniche intensivologiche e perioperatorie - Sezione di Microbiologia, Università Cattolica del Sacro Cuore, Milano, Italy.; Center for Global Health Research and Studies, Università Cattolica del Sacro Cuore, Roma, Italia., Noguera-Julian A; Malalties Infeccioses i Resposta Inflamatòria Sistèmica en Pediatria, Unitat d'Infeccions, Servei de Pediatria, Institut de Recerca Sant Joan de Déu, Barcelona, Spain.; Departament de Pediatria, Universitat de Barcelona, Barcelona, Spain.; Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública, Madrid, Spain.; Red de Investigación Translacional en Infectología Pediátrica, Madrid, Spain., Moroni R; Direzione Scientifica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Hernández-Bartolomé A; 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 {CIBER INFEC), Instituto de Salud Carlos III, Madrid, Spain., Fritschi N; Mycobacterial and Migrant Health Research Group, University of Basel Children's Hospital Basel and Department of Clinical Research, University of Basel, Basel, Switzerland., Lancella L; Paediatric Infectious Diseases Unit, Bambino Gesù Children Hospital, Rome, Italy., Cursi L; Paediatric Infectious Diseases Unit, Bambino Gesù Children Hospital, Rome, Italy., Soler-Garcia A; Malalties Infeccioses i Resposta Inflamatòria Sistèmica en Pediatria, Unitat d'Infeccions, Servei de Pediatria, Institut de Recerca Sant Joan de Déu, Barcelona, Spain., Krüger R; Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité - Universitätsmedizin, Berlin, Germany., Feiterna-Sperling C; Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité - Universitätsmedizin, Berlin, Germany., Sali M; Dipartimento di Scienze biotecnologiche di base, cliniche intensivologiche e perioperatorie - Sezione di Microbiologia, Università Cattolica del Sacro Cuore, Milano, Italy.; Dipartimento di Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario 'A. Gemelli', IRCCS, Rome, Italy., Lo Vecchio A; Department of Translational Medical Sciences, Pediatric Infectious Diseases Unit, University of Naples Federico II, Naples, Italy., Scarano S; Department of Translational Medical Sciences, Pediatric Infectious Diseases Unit, University of Naples Federico II, Naples, Italy., Hernanz Lobo A; 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 {CIBER INFEC), Instituto de Salud Carlos III, Madrid, Spain., Espiau M; Paediatric Infectious Diseases and Immunodeficiencies Unit, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Soriano-Arandes A; Paediatric Infectious Diseases and Immunodeficiencies Unit, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Cetin BS; Department of Pediatric Infectious Diseases, Erciyes University, Kayseri, Turkey., Brinkmann F; Department of Paediatric Pulmonology, Children's Hospital, Ruhr-University, Bochum, Germany., Ozere I; Riga Stradiņš University, Riga, Latvia., Baquero-Artigao F; Red de Investigación Translacional en Infectología Pediátrica, Madrid, Spain.; Hospital Infantil La Paz, Madrid, Spain.; CIBERINFEC, ISCIII, Madrid, Spain., Tsolia M; Panagiotis & Aglaia Kyriakou Children's Hospital, Athens, Greece., Milheiro Silva T; Hospital Dona Estefânia, Lisbon, Portugal., Bustillo-Alonso M; Hospital Universitario Miguel Servet, Zaragoza, Spain., Martín Nalda A; Paediatric Infectious Diseases and Immunodeficiencies Unit, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Mancini M; Specialty School of Pediatrics, Alma Mater Studiorum, University of Bologna, Bologna, Italy., Starshinova A; St. Petersburg Scientific Research Institute of Phthisiopulmonology, St. Petersburg, Russian Federation., Ritz N; Mycobacterial and Migrant Health Research Group, University of Basel Children's Hospital Basel and Department of Clinical Research, University of Basel, Basel, Switzerland.; Department of Paediatrics and Paediatric Infectious Diseases, Children's Hospital Lucerne Lucerne Cantonal Hospital, Lucerne, Switzerland.; Department of Paediatrics, The University of Melbourne, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia., Velizarova S; Medical University Sofia, Sofia, Bulgaria., Ferreras-Antolín L; Paediatric Infectious Diseases Unit, St. George's University Hospitals NHS Foundation Trust, London, UK., Götzinger F; Department of Paediatric and Adolescent Medicine, National Reference Centre for Childhood Tuberculosis, Klinik Ottakring, Vienna, Austria., Bilogortseva O; Ukraine. Department of Children Phthisiology, National Institution of Phthisiology and Pulmonology of National Academy of Medical sciences of Ukraine, Kiev, Ukraine.; Infectious diseases Centre «Clinic for treatment of children with HIV/AIDS» National Specialized Children's Hospital 'OKHMATDYT', Kiev, Ukraine., Chechenyeva V; Ukraine. Department of Children Phthisiology, National Institution of Phthisiology and Pulmonology of National Academy of Medical sciences of Ukraine, Kiev, Ukraine.; Infectious diseases Centre «Clinic for treatment of children with HIV/AIDS» National Specialized Children's Hospital 'OKHMATDYT', Kiev, Ukraine., Tebruegge M; Department of Paediatrics, The University of Melbourne, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia m.tebruegge@ucl.ac.uk.; Department of Infection, Immunity and Inflammation, UCL Great Ormond Street Institute of Child Health, University College London, London, UK., Santiago-García B; 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 {CIBER INFEC), Instituto de Salud Carlos III, Madrid, Spain.
Jazyk:	angličtina
Zdroj:	Thorax [Thorax] 2023 Mar; Vol. 78 (3), pp. 288-296. Date of Electronic Publication: 2022 Oct 25.
DOI:	10.1136/thorax-2022-218929
Abstrakt:	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. Competing Interests: Competing interests: DB participated in a Qiagen advisory board meeting on the use of IGRAs in children <5 years of age. The manufacturers had no influence on the study design, data collection, analysis or interpretation, writing of the manuscript or the decision to submit the data for publication. BS-G and MT have received support from Cepheid for a project on molecular TB diagnostics unrelated to the study reported here. MT has received QuantiFERON-TB assays at reduced pricing or free of charge for TB diagnostics projects from the manufacturer (Cellestis/Qiagen) in the past, and has received support for conference attendance from Cepheid. (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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