Position statement on interferon-γ release assays for the detection of latent tuberculosis infection

Authors

  • Ivan Bastian Microbiology Infectious Diseases (MID) Directorate, SA Pathology
  • Chris Coulter
  • National Tuberculosis Advisory Committee (NTAC)

DOI:

https://doi.org/10.33321/cdi.2017.41.43

Keywords:

tuberculosis, management, latent tuberculosis infection

Abstract

Interferon-y release assays (IGRAs), such as the Quantiferon (QIFN) TB-Gold Plus assay (Qiagen, Hilden, Germany) and the T-SPOT.TB test (Oxford Immunotec Limited, Abingdon, United Kingdom), are marketed as a substitute for the tuberculin skin test (TST) for the detection of latent tuberculosis infection (LTBI). The relative merits of IGRAs and TST have been hotly debated over the last decade. The specificity of IGRAs has been optimised by using Mycobacterium tuberculosis-specific antigens. However, IGRAs are functional in vitro T-cell-based assays that may lack reproducibility due to specimen collection, transport, processing and kit manufacturing issues.

Longitudinal studies comparing the ability of IGRAs and TST to predict the future development of active tuberculosis disease (TB) are the ultimate arbiters on the respective utility of these assays. Three meta-analyses addressing this comparison have now been published and clinical experience with IGRAs is accumulating. The systematic reviews show that IGRAs and TST have similar (but poor) ability to identify patients with LTBI at risk of developing active TB disease. The improved specificity of IGRAs however may reduce the number of patients requiring preventative therapy.

Based on these meta-analyses, The National Tuberculosis Advisory Committee (NTAC) now recommends either TST or an IGRA for the investigation of LTBI in most circumstances. Both tests may be used in patients where the risk of progression to active TB disease is high and the disease sequelae potentially severe (eg. LTBI testing in immunocompromised patients or those commencing anti-tumour necrosis factor-α (TNF) therapy). Neither test should be used in the investigation of active TB disease (though TST and/or IGRA may be used as supplementary tests in paediatric cases). The choice of test for serial testing in healthcare workers (HCWs) remains controversial. A preference remains for TST in this circumstance because IGRAs have been bedevilled by higher rates of reversions and conversions when used for serial testing. These recommendations supersede all previous NTAC IGRA statements.

Downloads

Download data is not yet available.

References

World Health Organization. Toward tuberculosis elimination: an action framework for low-incidence countries. Document WHO/HTM/TB/2014.13. Geneva: WHO, 2014.

National Tuberculosis Advisory Committee. The strategic plan for control and elimination of tuberculosis in Australia: 2016 – 2020. (Manuscript in preparation).

National Tuberculosis Advisory Committee. Position statement on interferon-γ release assays in the detection of latent tuberculosis infection. Commun Dis Intell Q Rep 2012; 36: 125-31.

Denkinger CM, Dheda K, Pai M. Guidelines on interferon-γ release assays for tuberculosis infection: concordance, discordance or confusion? Clin Microbiol Infect 2011; 17: 806-14.

Lee E, Holzman RS. Evolution and current use of the tuberculin test. Clin Infect Dis 2002; 34: 365-70.

Pai M, Kunimoto D, Jamieson F, Menzies D. Diagnosis of latent tuberculosis infection, chapter 4. In: Canadian Tuberculosis Standards – 7th edition. Canadian Thoracic Society and The Public Health Agency of Canada, 2013. Available at: http://www.respiratoryguidelines.ca/sites/all/files/Canadian_TB_Standards_7th_Edition_ENG.pdf

Andersen P, Munk ME, Pollock JM, Doherty TM. Specific immune-based diagnosis of tuberculosis. Lancet 2000; 356: 1099-104.

Quantiferon TB-Gold Plus package insert. Qiagen, February 2016. Available at: http://www.quantiferon.com/wp- content/uploads/2017/04/English_QFTPlus_ELISA_R04_022016.pdf

T-SPOT.TB package insert. Oxford Immunotec Limited, 2013. Available at: http://www.oxfordimmunotec.com/international/wp-content/uploads/sites/3/PI-TB-IVD-UK-v2f288.pdf

Pai M, Denkinger CM, Kik SV, et al. Gamma interferon release assays for the detection of Mycobacterium tuberculosis infection. Clin Microbiol Rev 2014; 27: 3-20.

Diel R, Loddenkemper R, Nienhaus A. Predictive value of interferon-γ release assays and tuberculin skin testing for progression from latent TB infection to disease state: a meta-analysis. Chest 2012; 142: 63-75.

Rangaka MX, Wilkinson KA, Glynn JR, et al. Predictive value of interferon-γ release assays for incident active tuberculosis: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12: 45-55.

World Health Organization. Guidelines on the management of latent tuberculosis infection. Document WHO/HTM/TB/2015.01. Geneva: WHO, 2015.

Alexander TS, Miller MB, Gilligan P. Point-Counterpoint: Should interferon gamma release assays become the standard method for screening patients for Mycobacterium tuberculosis infections in the United States? J Clin Microbiol 2011; 49: 2086-92.

European Centre for Disease Prevention and Control. Use of interferon-gamma release assays in support of TB diagnosis. Stockholm: ECDC, 2011. Available at: http://ecdc.europa.eu/en/publications/Publications/1103_GUI_IGRA.pdf

Tagmouti S, Slater M, Benedetti A, et al. Reproducibility of interferon gamma (IFN-γ) release Assays. A systematic review. Ann Am Thorac Soc 2014; 11: 1267-76.

Metcalfe JZ, Everett C, Steingart KR et al. Interferon-γ release assays for active pulmonary tuberculosis diagnosis in adults in low- and middle-income countries: systematic review and meta-analysis. J Infect Dis 2011; 204 Suppl 4: S1120-9.

Fan L, Chen Z, Hao XH, et al. Interferon-gamma release assays for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis. FEMS Immunol Med Microbiol 2012; 65: 456-66.

Sester M, Sotgiu G, Lange C, et al. Interferon-γ release assays for the diagnosis of active tuberculosis: a systematic review and meta-analysis. Eur Respir J 2011; 37: 100-11.

Tsang T, Waring J. retrospective study on the appropriate implementation of Quantiferon Gold Assay in a tertiary setting. Respirology 2010; 14(S1): TP180.

Erkens C, Kamphorst M, Abubakar I, et al. Tuberculosis contact investigation in low prevalence countries: a European consensus. Eur Respir J 2010; 36: 925-49.

Herrera V, Perry S, Parsonnet J, Banaei N. Clinical application and limitations of interferon-γ release assays for the diagnosis of latent tuberculosis infection. Clin Infect Dis 2011; 52: 1031-7.

Getahun H, Matteelli A, Chaisson RE, Raviglione M. Latent Mycobacterium tuberculosis Infection. N Engl J Med 2015; 372: 2127-35.

Grinsdale J, Ho C, Banouvong H, Kawamura L. Programmatic impact of using QuantiFERON®-TB Gold in routine contact investigation activities. Int J Tuberc Lung Dis 2011; 15: 1614-20.

Goebel K, Tay E, Denholm J. Supplemental use of an interferon-gamma release assay in a state-wide tuberculosis contact tracing program in Victoria: a six-year review. Commun Dis Intell 2015; 39: 191-6.

Farhat M, Greenaway C, Pai M, Menzies D. False-positive tuberculin skin tests: what is the absolute effect of BCG and non-tuberculous mycobacteria? Int J Tuberc Lung Dis 2006 10: 1192-204.

Machingaidze S, Wiysonge CS, Gonzalez-Angulo Y, et al. The utility of an interferon gamma release assay for diagnosis of latent tuberculosis infection and disease in children: a systematic review and meta-analysis. Pediatr Infect Dis J 2011; 30: 694–700.

Mandalakas AM, Detjen AK, Hesseling AC, et al. Interferon-gamma release assays and childhood tuberculosis: systematic review and meta-analysis. Int J Tuberc Lung Dis 2011; 15:1018–1032.

Kampmann B, Whittaker E, Williams A, Walters S, Gordon A, Martinez-Alier N, et al. Interferon-gamma release assays do not identify more children with active tuberculosis than the tuberculin skin test. Eur Respir J 2009; 33: 1374–1382.

Sollai S, Galli L, de Martino M, Chiappini E. Systematic review and meta-analysis on the utility of Interferon-gamma release assays for the diagnosis of Mycobacterium tuberculosis infection in children: a 2013 update. BMC Infect Dis 2014; 14 Suppl 1: S1-6.

Chiappini E, Bonsignori F, Mazzantini R, et al. Interferon-gamma release assay sensitivity in children younger than 5 years is insufficient to replace the use of tuberculin skin test in western countries. Pediatr Infect Dis J 2014: 33: 1291-3.

Mandalakas AM, Kirchner HL, Walzl G, et al. Optimizing the detection of recent tuberculosis infection in children in a high tuberculosis–HIV burden setting. Am J Resp Crit Care Med 2015; 191: 120-130.

Connell TG, Ritz N, Paxton GA, et al. A three-way comparison of tuberculin skin testing, QuantiFERON-TB gold and T-SPOT. TB in children. PLoS ONE 2008; 3: e2624

Connell TG, Tebruegge M, Ritz N, et al. Indeterminate interferon-gamma release assay results in children. Pediatr Infect Dis J 2010; 29: 285–286.

Seddon JA, Paton J, Nademi Z, et al. The impact of BCG vaccination on tuberculin skin test responses in children is age dependent: evidence to be considered when screening children with tuberculosis infection. Thorax Published Online First: [22 June 2016] doi:10.1136/thoraxjnl-2015-207687

Taylor EM, Painter J, Posey DL, et al. Latent tuberculosis infection among immigrant and refugee children arriving in the United States: 2010. J Immigrant Minority Health 2015 Sep 12 [Epub ahead of print]

Méndez-Echevarría A, González-Muñoz M, Mellado MJ , et al; Spanish Collaborative Group for Study of QuantiFERON-TB GOLD Test in Children. Interferon-γ release assay for the diagnosis of tuberculosis in children. Arch Dis Child 2012; 97: 514–516.

Spicer KB, Turner J, Wang SH, et al. Tuberculin skin testing and T-SPOT.TB in internationally adopted children. Pediatr Infect Dis J 2015; 34: 599–603.

Howley MM, Painter JA, Katz DJ, et al; Tuberculosis Epidemiologic Studies Consortium. Evaluation of QuantiFERON-TB Gold in-tube and tuberculin skin tests among immigrant children being screened for latent tuberculosis infection. Pediatr Infect Dis J 2015; 34: 35–39.

Australian Technical Advisory Group on Immunisation (ATAGI). The Australian immunisation handbook 10th ed (2015 update). Canberra: Australian Government Department of Health, 2015. Available at: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/7B28E87511E08905CA257D4D001DB1F8/$File/Aus-Imm-Handbook.pdf

Tarlo SM, Day JH, Mann P, Day MP. Immediate hypersensitivity to tuberculin. Chest 1977; 71: 33-7.

Toms, C., Stapledon, R., Coulter, C., Douglas, P., National Tuberculosis Advisory Committee for CDNA & Australian Mycobacterium Reference Laboratory Network. Tuberculosis notifications in Australia, 2014. Commun Dis Intell 41, E243–E259 (2017)

Pareek M, Watson JP, Ormerod LP, et al. Screening of immigrants in the UK for imported latent tuberculosis: a multicentre cohort study and cost-effectiveness analysis. Lancet Infect Dis 2011; 11: 435–444.

Pareek M, Baussano I, Abubakar I, et al. Evaluation of immigrant tuberculosis screening in industrialized countries. Emerg Infect Dis 2012; 18: 1422-9.

Selwyn PA, Hartel D, Lewis VA, et al. A prospective study of the risk of tuberculosis among intravenous drug users with human immunodeficiency virus infection. N Engl J Med 1989; 320: 545-50.

Cattamanchi A et al. Interferon-Gamma Release Assays for the Diagnosis of Latent Tuberculosis Infection in HIV-Infected Individuals: A Systematic Review and Meta-Analysis. J Acquir Immune Defic Syndr 2011; 56:230–238.

Ramos JM, Robledano C, Masiá M, et al. Contribution of interferon gamma release assays testing to the diagnosis of latent tuberculosis infection in HIV-infected patients: a comparison of QuantiFERON-TB Gold In Tube, T-SPOT.TB and tuberculin skin test. BMC Infect Dis 2012; 12: 169.

Cheallaigh CN, Fitzgerald I, Grace J, et al. Interferon gamma release assays for the diagnosis of latent TB infection in HIV-infected individuals in a low TB burden country. PLoS One 2013; 8(1): e53330.

Bourgarit A, Baron G, Breton G, et al. Latent tuberculosis infection screening and 2-year outcome in antiretroviral-naive HIV-infected patients in a low-prevalence country. Ann Am Thorac Soc 2015; 12: 1138-45.

Santin M, Muñoz L, Rigau D. Interferon-γ release assays for the diagnosis of tuberculosis and tuberculosis infection in HIV-infected adults: a systematic review and meta-analysis. PLoS One 2012; 7(3): e32482.

National Institute for Health and Care Excellence (NICE). Tuberculosis guideline. Available at: https://www.nice.org.uk/guidance/ng33.

Lee SS, Lin HH, Tsai HC, et al. A Clinical Algorithm to Identify HIV Patients at High Risk for Incident Active Tuberculosis: A Prospective 5-Year Cohort Study. PLoS One. 2015 Aug 17;10(8):e0135801. doi: 10.1371/journal.pone.0135801. eCollection 2015.

Winthrop KA. The risk and prevention of tuberculosis: screening strategies to detect latent tuberculosis among rheumatoid arthritis patients who use biologic therapy. Int J Adv Rheumatol 2010; 8: 43–52.

Jick SS, Lieberman ES, Rahman MU, et al. Glucocorticoid use, other associated factors, and the risk of tuberculosis. Arthritis Rheum 2006; 55: 19–26.

Tymms K, Therapeutics Committee, Australian Rheumatology Association. Screening for latent tuberculosis infection (LTBI) prior to use of biological agents in Australia. Available at: http://rheumatology.org.au/downloads/SCREENINGFORLATENTTUBERCULOSISINFECTION.pdf

Lorenzetti R, Zullo A, Ridola L, et al. Higher risk of tuberculosis reactivation when anti-TNF is combined with immunosuppressive agents: a systematic review of randomised control trials. Ann Med 2014; 46: 547-54.

Smith R, Cattamanchi A, Steingart KR, et al. Interferon-gamma release assays for diagnosis of latent tuberculosis infection: evidence in immune-mediated inflammatory disorders. Curr Opin Rheumatol 2011; 23: 377-84.

Theodoropoulos N, Lanternier F, Rassiwala J, et al. Use of the QuantiFERON-TB Gold interferon-gamma release assay for screening transplant candidates: a single-center retrospective study. Transpl Infect Dis 2012; 14: 1-8.

Jafri SM, Singal AG, Kaul D, Fontana RJ. Detection and management of latent tuberculosis in liver transplant patients. Liver Transpl 2011; 17: 306-14

Triverio P-A, Bridevaux P-O, Roux-Lombard P, et al. Interferon-gamma release assays versus tuberculin skin testing for detection of latent tuberculosis in chronic haemodialysis patients. Nephrol Dial Transplant 2009 24: 1952–6.

Joshi M, Monson TP, Woods GL. Use of interferon-gamma release assays in a health care worker screening program: Experience from a tertiary care centre in the United States. Can Respir J 2012; 19(2): 84-88

Daley CL, Reves RR, Beard MA, et al. A summary of meeting proceedings on addressing variability around the cut point in serial interferon-γ release assay testing. Infect Control Hosp Epidemiol 2013; 34: 625-30.

Kobashi Y, Sugiu T, Mouri K, et al. Indeterminate results of QuantiFERON TB-2G test performed in routine clinical practice. Eur Respir J 2009; 33: 812-5.

Nienhaus A, Schablon A, Costa JT, Diel R. Systematic review of cost and cost-effectiveness of different TB-screening strategies. BMC Health Serv Res 2011; 11: 247

Oxlade O, Pinto M, Trajman A, Menzies D. How methodologic differences affect results of economic analyses: a systematic review of interferon gamma release assays for the diagnosis of LTBI. PLoS One 2013; 8(3): e56044.

Campbell JR, Sasitharan T, Marra F. A systematic review of studies evaluating the cost utility of screening high-risk populations for latent tuberculosis infection. Appl Health Econ Health Policy 2015; 13: 325-40.

Downloads

Published

01/12/17

How to Cite

Bastian, Ivan, Chris Coulter, and National Tuberculosis Advisory Committee (NTAC). 2017. “Position Statement on Interferon-γ Release Assays for the Detection of Latent Tuberculosis Infection”. Communicable Diseases Intelligence 41 (December):322-36. https://doi.org/10.33321/cdi.2017.41.43.

Issue

Section

Policy and guidelines

Categories