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The definition of tuberculosis infection based on the spectrum of tuberculosis disease

Giovanni Battista Migliori, Catherine W.M. Ong, Linda Petrone, Lia D'Ambrosio, Rosella Centis, Delia  Goletti
Breathe 2021 17: 210079; DOI: 10.1183/20734735.0079-2021
Giovanni Battista Migliori
1Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy
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  • ORCID record for Giovanni Battista Migliori
  • For correspondence: giovannibattista.migliori@fsm.it
Catherine W.M. Ong
2Dept of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
3Institute for Health Innovation and Technology (iHealthtech), National University of Singapore, Singapore
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Linda Petrone
4Translational Research Unit, National Institute for Infectious Diseases “Lazzaro Spallanzani”-IRCCS, Rome, Italy
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Lia D'Ambrosio
5Public Health Consulting Group, Lugano, Switzerland
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Rosella Centis
1Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy
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Delia  Goletti
4Translational Research Unit, National Institute for Infectious Diseases “Lazzaro Spallanzani”-IRCCS, Rome, Italy
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  • Article
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  • Figure 1
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    Figure 1

    The “continuum process” leading from TB infection to disease. BCG: bacille Calmette–Guérin; DX: diagnosis; TX: treatment; IGRAs: interferon-γ release assays; TST: tuberculin skin test; (L)TBI: (latent) TB infection.

Tables

  • Figures
  • Table 1

    Tests for diagnosing TB infection

    TSTNew skin testsIGRAs and in vitro testsNew in vitro tests
    ExamplesDiaskin test, EC-skin test and c-TbQuantiFERON-TB Gold Plus and T-SPOT.TB
    Standard E TB-Feron, AdvanSure TB-IGRA ELISA, LIOFeron TB/LTBI, IP-10 ELISA
    QIAreach QuantiFERON-TB, the ichroma IGRA-TB, STANDARD F TB-Feron FIA, Erythra TB-test, IP-10 IGRA LF
    VIDAS TB-IGRA, AdvanSure I3 TB-IGRA, LIAISON QuantiFERON-TB Gold Plus, GBTsol Latent TB Test Kit
    Character­isticsIntradermal administration of PPD in the forearm
    Cold chain requirement for PPD
    Induration reading within 72 h
    Trained staff for administration and reading the skin induration
    Intradermal administration of ESAT-6/CFP-10 antigens in the forearm
    Cold chain requirement for ESAT-6/CFP-10
    Induration reading within 72 h
    Trained staff for administration and reading the skin induration
    In vitro tests with internal controls
    Detection of IFN-γ or other markers in blood or PBMCs using ELISA
    Need for fresh samples
    Incubation time of 16–24 h
    Need for efficient sample transport system
    Need for different blood collection tubes depending on the altitude
    Need for laboratory infrastructure
    Assay time:
    20 min for IP-10 ELISA;
    1.5–4 h for QuantiFERON-TB Gold Plus, T-SPOT.TB, Standard E TB-Feron, AdvanSure TB-IGRA ELISA, LIOFeron TB/LTBI
    In vitro tests with internal controls
    Detection of IFN-γ or other biomarkers in the blood or isolated T-cells using LFA or chemiluminescence or ELFA systems
    Need for fresh samples
    Incubation time of 0#–24 h
    Need for efficient sample transport system
    Need for different blood collection tubes depending on the altitude
    Need for laboratory infrastructure for some assays¶
    Assay time:
    15–20 min for QIAreach QuantiFERON-TB, STANDARD F TB-Feron FIA, ichroma IGRA-TB, AdvanSure I3 TB-IGRA, Erythra TB test;
    46 min to 17 h+ for LIAISON QuantiFERON-TB Gold Plus, GBTsol Latent TB Test Kit, GBTsol Latent TB Test Kit, IP-10 IGRA LF and VIDAS TB-IGRA
    Disadvan­tagesFalse positive results in BCG-vaccinated individuals
    False negative results in immunocom­promised hosts
    Inaccuracy/bias in performing the test and in reading it
    Second visit needed
    False negative results in immunocom­promised hosts
    Inaccuracy/bias in performing the test and in reading it
    False negative results in immunocompromised
    Errors in the pre-analytical phase
    Misinterpretation of the assays
    Expensive
    Limited data
    We expect:
    Errors in the pre-analytical phase
    Misinterpretation of the assays
    Expensive
    AdvantagesUseful for large screening settings
    Cost-effective
    No laboratory infrastructure required
    Useful for large screening settings
    Cost-effective
    No laboratory infrastructure required
    Higher specificity for TB infection compared with TST
    No booster effect compared with TST
    No need for a second visit compared with TST
    Faster turn-around time compared with TST
    Higher specificity for TB infection compared with TST
    No booster effect
    No need for a second visit compared with TST
    Lower turn-around time compared with IGRAs
    Very likely: faster§ and/or less handlingƒ compared with IGRAs

    Assay time: time from post-incubation and result delivery. Incubation time: time of stimulation. BCG: bacille Calmette–Guérin; ELFA: enzyme-linked fluorescence assay; ELISA: enzyme-linked immunosorbent assay; LFA: lateral flow assay; PBMC: peripheral blood mononuclear cells. #: incubation time not required for Erythra TB-test; ¶: VIDAS TB-IGRA, AdvanSure I3 TB-IGRA, LIAISON QuantiFERON-TB Gold Plus; +: VIDAS TB-IGRA assay time is reported to be 17 h and includes incubation, post-incubation and result score; §: applies to QIAreach QuantiFERON-TB, the ichroma IGRA-TB, STANDARD F TB-Feron FIA, Erythra TB-test, AdvanSure I3 TB-IGRA; ƒ: applies to VIDAS TB-IGRA, LIAISON QuantiFERON-
TB Gold Plus.

    • Table 2

      Research priorities for TB infection

      Areas for researchSpecific areas
      Risks of progression from TB infection to TB diseaseEvaluation of the likelihood of progressing from TB infection to TB disease in the various at-risk populationsEvaluation of the incidence and risk of progression to TB disease in the following groups of patients:
       Diabetes mellitus
       Harmful alcohol use
       Tobacco use
       Underweight
       Silica exposure
       Steroid treatment
       Rheumatological diseases
       CancerEvaluation of the harms including stigmatisation and acceptability of testing and TB preventive therapy in risk groups
      Defining the best clinical algorithm to exclude TB disease from TB infectionPerformance and feasibility of these algorithms should be assessedCreating algorithms for children and pregnant womenIdentify feasible cost-effective methods for contact tracing
      Improved diagnostic tests and defining the performance of latent TB tests in at-risk populationsTests with improved performance and predictive value for progression to TB diseasePerformance of existing latent TB tests in at-risk populationsTests to determine TB reinfectionHow to use existing tests to best determine LTBI
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    The definition of tuberculosis infection based on the spectrum of tuberculosis disease
    Giovanni Battista Migliori, Catherine W.M. Ong, Linda Petrone, Lia D'Ambrosio, Rosella Centis, Delia  Goletti
    Breathe Sep 2021, 17 (3) 210079; DOI: 10.1183/20734735.0079-2021

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    The definition of tuberculosis infection based on the spectrum of tuberculosis disease
    Giovanni Battista Migliori, Catherine W.M. Ong, Linda Petrone, Lia D'Ambrosio, Rosella Centis, Delia  Goletti
    Breathe Sep 2021, 17 (3) 210079; DOI: 10.1183/20734735.0079-2021
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    • Article
      • Abstract
      • Abstract
      • Introduction
      • What new tests are available to diagnose TB infection?
      • What is new for treatment of TB infection?
      • What is new on TB infection from the public health perspective?
      • TB infection and subclinical disease policy development
      • Priorities for research
      • Conclusions
      • Acknowledgements
      • Footnotes
      • References
    • Figures & Data
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    • Respiratory infections and tuberculosis
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