Skip to main content
Top
Published in:

Open Access 01-02-2025 | Tuberculosis | RESEARCH

Performance evaluation of the LIOFeron®TB/LTBI IGRA for screening of paediatric LTBI and tuberculosis

Authors: Chiara Della Bella, Marco Antonio Motisi, Elisabetta Venturini, Sofia D’Elios, Evangelia Asvestopoulou, Agnese Maria Tamborino, Luisa Galli, Mario Milco D’Elios, Elena Chiappini

Published in: European Journal of Pediatrics | Issue 2/2025

Login to get access

Abstract

Purpose: High-accuracy diagnostic screening tests for Mycobacterium tuberculosis (MTB) infection are required, primarily to detect patients with latent infections (LTBIs) in order to avoid their progression to active tuberculosis disease. The performance of the novel IGRA LIOFeron®TB/LTBI was evaluated in children. The originality of this test is the new MTB antigen contained (l-alanine dehydrogenase), identified as a tool to differentiate active TB from LTBI infection. Methods: From March 2022 to November 2023, a population of 90 children was enrolled and grouped into healthy, active TB or LTBI individuals, based on diagnostic guidelines. The blood of all these participants was tested with LIOFeron®TB/LTBI assay in comparison to diagnosis, as gold standard, and to the current used IGRA QuantiFERON®-TB Gold Plus. Results: The two assays demonstrated an excellent concordance of their results with patients’ diagnosis of MTB infection. The performance of LIOFeron®TB/LTBI assay in terms of accuracy of MTB infection diagnosis was high at ROC analysis (AUC = 0.997), and the test showed 100% sensitivity in LTBI detection. The QuantiFERON®-TB Gold Plus sensitivity for LTBI detection was 85.7%.
Conclusions: Based on the obtained results, the LIOFeron®TB/LTBI assay appears to be a promising test for TB and LTBI screening among paediatric patients.
What is known:
• The detection of LTBI in children, exposed to MTB infections, followed by appropriate treatment, has a pivotal role in reducing tuberculosis burden.
• IGRA tests are easy-to-use methods for helping large TB screening in paediatrics.
What is new:
• The LIOFeron®TB/LTBI performance evaluation showed 100% of sensitivity in the detection of LTBI patients.
• The LIOFeron®TB/LTBI assay might be useful for the detection of LTBI and active tuberculosis paediatric patients.
Appendix
Available only for authorised users
Literature
2.
go back to reference Global tuberculosis report (2023) Geneva: World Health Organization; 2023. Licence: CC BY-NC-SA 3.0 IGO Global tuberculosis report (2023) Geneva: World Health Organization; 2023. Licence: CC BY-NC-SA 3.0 IGO
7.
go back to reference WHO (2023) Roadmap toward ending TB in children and adolescents, 3rd edn. Geneva, Switzerland, World Health Organization WHO (2023) Roadmap toward ending TB in children and adolescents, 3rd edn. Geneva, Switzerland, World Health Organization
13.
go back to reference Bastian I, Coulter C, National Tuberculosis Advisory Committee (NTAC) (2017) Position statement on interferon-γ release assays for the detection of latent tuberculosis infection. Commun Dis Intell Q Rep. 41(4):E322–E336PubMed Bastian I, Coulter C, National Tuberculosis Advisory Committee (NTAC) (2017) Position statement on interferon-γ release assays for the detection of latent tuberculosis infection. Commun Dis Intell Q Rep. 41(4):E322–E336PubMed
19.
go back to reference Chiappini E, Della Bella C, Bonsignori F, Sollai S, Amedei A, Galli L, Niccolai E, Del Prete G, Singh M, D'Elios MM, de Martino M (2012) Potential role of M. tuberculosis specific IFN-γ and IL-2 ELISPOT assays in discriminating children with active or latent tuberculosis. PLoS One 7(9):e46041. https://doi.org/10.1371/journal.pone.0046041 Chiappini E, Della Bella C, Bonsignori F, Sollai S, Amedei A, Galli L, Niccolai E, Del Prete G, Singh M, D'Elios MM, de Martino M (2012) Potential role of M. tuberculosis specific IFN-γ and IL-2 ELISPOT assays in discriminating children with active or latent tuberculosis. PLoS One 7(9):e46041. https://​doi.​org/​10.​1371/​journal.​pone.​0046041
21.
go back to reference Agren D, Stehr M, Berthold CL, Kapoor S, Oehlmann W, Singh M, Schneider G (2008) Three-dimensional structures of apo- and holo-L-alanine dehydrogenase from Mycobacterium tuberculosis reveal conformational changes upon coenzyme binding. J Mol Biol 377(4):1161–73. https://doi.org/10.1016/j.jmb.2008.01.091 Agren D, Stehr M, Berthold CL, Kapoor S, Oehlmann W, Singh M, Schneider G (2008) Three-dimensional structures of apo- and holo-L-alanine dehydrogenase from Mycobacterium tuberculosis reveal conformational changes upon coenzyme binding. J Mol Biol 377(4):1161–73. https://​doi.​org/​10.​1016/​j.​jmb.​2008.​01.​091
28.
go back to reference American Academy of Pediatrics (2021). Red Book: 2021–2024 Report of the Committee on Infectious Diseases. 32nd ed. AAP. American Academy of Pediatrics (2021). Red Book: 2021–2024 Report of the Committee on Infectious Diseases. 32nd ed. AAP.
30.
go back to reference Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, Keane J, Lewinsohn DA, Loeffler AM, Mazurek GH et al (2017) Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention clinical practice guidelines: diagnosis of tuberculosis in adults and children. Clin Infect Dis 64(2):111–115. https://doi.org/10.1093/cid/ciw778CrossRefPubMed Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, Keane J, Lewinsohn DA, Loeffler AM, Mazurek GH et al (2017) Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention clinical practice guidelines: diagnosis of tuberculosis in adults and children. Clin Infect Dis 64(2):111–115. https://​doi.​org/​10.​1093/​cid/​ciw778CrossRefPubMed
32.
go back to reference Lionex (2019) LIOFeron®TB-LTBI_EN_Instructions-for-use-rev.-8.0. Lionex (2019) LIOFeron®TB-LTBI_EN_Instructions-for-use-rev.-8.0.
33.
go back to reference Qiagen (2016) QuantiFERON-TB Gold Plus Package Insert. Qiagen (2016) QuantiFERON-TB Gold Plus Package Insert.
37.
go back to reference DeLong ER, DeLong DM, Clarke-Pearson DL (1988) Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics 44(3):837–845 (PMID: 3203132)CrossRefPubMed DeLong ER, DeLong DM, Clarke-Pearson DL (1988) Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics 44(3):837–845 (PMID: 3203132)CrossRefPubMed
38.
go back to reference Garazzino S, Galli L, Chiappini E, Pinon M, Bergamini BM, Cazzato S, Dal Monte P, Dodi I, Lancella L, Esposito S, et al, SITIP IGRA Study Group (2014) Performance of interferon-γ release assay for the diagnosis of active or latent tuberculosis in children in the first 2 years of age: a multicenter study of the Italian Society of Pediatric Infectious Diseases. Pediatr Infect Dis J. 33(9):e226–31. https://doi.org/10.1097/INF.0000000000000353. Garazzino S, Galli L, Chiappini E, Pinon M, Bergamini BM, Cazzato S, Dal Monte P, Dodi I, Lancella L, Esposito S, et al, SITIP IGRA Study Group (2014) Performance of interferon-γ release assay for the diagnosis of active or latent tuberculosis in children in the first 2 years of age: a multicenter study of the Italian Society of Pediatric Infectious Diseases. Pediatr Infect Dis J. 33(9):e226–31. https://​doi.​org/​10.​1097/​INF.​0000000000000353​.
41.
go back to reference Goscé L, Allel K, Hamada Y, Surkova E, Kontsevaya I, Wang TT, Liu WH, Matveev A, Ziganshina LE, Korobitsyn A et al (2024) Systematic review of the economic impact of novel Mycobacterium tuberculosis specific antigen-based skin tests for detection of TB infection compared with tuberculin skin test and interferon-gamma release assays. PLOS Glob Public Health 4(10):e0003655. https://doi.org/10.1371/journal.pgph.0003655CrossRefPubMedPubMedCentral Goscé L, Allel K, Hamada Y, Surkova E, Kontsevaya I, Wang TT, Liu WH, Matveev A, Ziganshina LE, Korobitsyn A et al (2024) Systematic review of the economic impact of novel Mycobacterium tuberculosis specific antigen-based skin tests for detection of TB infection compared with tuberculin skin test and interferon-gamma release assays. PLOS Glob Public Health 4(10):e0003655. https://​doi.​org/​10.​1371/​journal.​pgph.​0003655CrossRefPubMedPubMedCentral
47.
go back to reference Hirabayashi R, Nakayama H, Yahaba M, Yamanashi H, Kawasaki T, Japanese TB Clinical Practice Guideline Systematic Review Task Force (2024) Utility of interferon-gamma releasing assay for the diagnosis of active tuberculosis in children: a systematic review and meta-analysis. J Infect Chemother. 30(6):516–525. https://doi.org/10.1016/j.jiac.2023.12.007. Hirabayashi R, Nakayama H, Yahaba M, Yamanashi H, Kawasaki T, Japanese TB Clinical Practice Guideline Systematic Review Task Force (2024) Utility of interferon-gamma releasing assay for the diagnosis of active tuberculosis in children: a systematic review and meta-analysis. J Infect Chemother. 30(6):516–525. https://​doi.​org/​10.​1016/​j.​jiac.​2023.​12.​007.
Metadata
Title
Performance evaluation of the LIOFeron®TB/LTBI IGRA for screening of paediatric LTBI and tuberculosis
Authors
Chiara Della Bella
Marco Antonio Motisi
Elisabetta Venturini
Sofia D’Elios
Evangelia Asvestopoulou
Agnese Maria Tamborino
Luisa Galli
Mario Milco D’Elios
Elena Chiappini
Publication date
01-02-2025
Publisher
Springer Berlin Heidelberg
Published in
European Journal of Pediatrics / Issue 2/2025
Print ISSN: 0340-6199
Electronic ISSN: 1432-1076
DOI
https://doi.org/10.1007/s00431-025-05972-6

Keynote webinar | Spotlight on adolescent vaping

Growing numbers of young people are using e-cigarettes, despite warnings of respiratory effects and addiction. How can doctors tackle the epidemic, and what health effects should you prepare to manage in your clinics?

Prof. Ann McNeill
Dr. Debbie Robson
Benji Horwell
Developed by: Springer Medicine
Watch now