Pneumology - Reviews
1 September 2025
Early Access
Interferon-γ release assay
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
90
Views
49
Downloads
Authors
Traditionally, tuberculosis (TB) has been viewed as having two distinct manifestations, known as TB infection (TBI) and TB disease. The spectrum, however, has recently been expanded to include the elimination of TBI with the help of innate and/or adaptive immunity, TBI, incipient and subclinical TB disease, and TB disease. Epidemiologically speaking, identifying individuals with TBI is critical since diagnosis and treatment of TBI are essential in controlling the TB burden. It is important to identify high-risk individuals with TBI who are more likely to progress to active TB disease. There are two diagnostic methods for identifying TBI. These include the conventional tuberculin skin test (TST) and interferon-γ release assay (IGRA). However, these methods are not the ‘gold standard.’ Furthermore, all of these methods are indirect, relying on the host’s adaptive immune response to Mycobacterium tuberculosis-derived protein antigens. This review will describe the various tests for TBI, such as TST, IGRAs, newer skin and blood tests, methods for performing IGRAs, interpretation strategies, and limitations.
Altmetrics
Downloads
Download data is not yet available.
Citations
WHO. Global tuberculosis report 2023. Available from: https://www.who.int/publications/i/item/9789240083851.
Kiazyk S, Ball TB. Latent tuberculosis infection: an overview. Can Commun Dis Rep 2017;43:62-6. DOI: https://doi.org/10.14745/ccdr.v43i34a01
Mack U, Migliori GB, Sester M, et al. LTBI: latent tuberculosis infection or lasting immune responses to M. tuberculosis? A TBNET consensus statement. Eur Respir J 2009;33:956-73. DOI: https://doi.org/10.1183/09031936.00120908
WHO. WHO Global tuberculosis report 2018. Available from: https://www.who.int/publications-detail-redirect/9789240013131.
Houben RMGJ, Dodd PJ. The global burden of latent tuberculosis infection: a re-estimation using mathematical modelling. PLoS Med 2016;13:e1002152. DOI: https://doi.org/10.1371/journal.pmed.1002152
Menzies NA, Cohen T, Hill AN, et al. Prospects for tuberculosis elimination in the United States: results of a transmission dynamic model. Am J Epidemiol 2018;187:2011-20. DOI: https://doi.org/10.1093/aje/kwy094
Grange JM. Koch's Tubercle Bacillus - a centenary reappraisal. Zentralbl Bakteriol Mikrobiol Hyg A Med Mikrobiol Infekt Parasitol 1982;251:297-307. DOI: https://doi.org/10.1016/S0174-3031(82)80100-5
Daniel TM. The history of tuberculosis. Respir Med 2006;100:1862-70. DOI: https://doi.org/10.1016/j.rmed.2006.08.006
Yang H, Kruh-Garcia NA, Dobos KM. Purified protein derivatives of tuberculin--past, present, and future. FEMS Immunol Med Microbiol 2012;66:273-80. DOI: https://doi.org/10.1111/j.1574-695X.2012.01002.x
Pollock L, Basu Roy R, Kampmann B. How to use: interferon γ release assays for tuberculosis. Arch Dis Child Educ Pract Ed 2013;98:99-105. DOI: https://doi.org/10.1136/archdischild-2013-303641
Huebner RE, Schein MF, Bass JB Jr. The tuberculin skin test. Clin Infect Dis 1993;17:968-75. DOI: https://doi.org/10.1093/clinids/17.6.968
Markowitz N, Hansen NI, Wilcosky TC, et al. Tuberculin and anergy testing in HIV-seropositive and HIV-seronegative persons. Pulmonary Complications of HIV Infection Study Group. Ann Intern Med 1993;119:185-93. DOI: https://doi.org/10.7326/0003-4819-119-3-199308010-00002
Menzies D. Interpretation of repeated tuberculin tests. Boosting, conversion, and reversion. Am J Respir Crit Care Med 1999;159:15-21. DOI: https://doi.org/10.1164/ajrccm.159.1.9801120
Streeton JA, Desem N, Jones SL. Sensitivity and specificity of a gamma interferon blood test for tuberculosis infection. Int J Tuberc Lung Dis 1998;2:443-50.
Food and Drug Administration, Center for Devices and Radiological Health. QuantiFERON®-TB - P010033 [Letter]. Rockville, MD: Food and Drug Administration, 2002. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P010033.
Lalvani A, Richeldi L, Kunst H. Interferon gamma assays for tuberculosis. Lancet Infect Dis 2005;5:322-4; author reply 325-7 DOI: https://doi.org/10.1016/S1473-3099(05)70118-3
Mahairas GG, Sabo PJ, Hickey MJ, et al. Molecular analysis of genetic differences between Mycobacterium bovis BCG and virulent M. bovis. J Bacteriol 1996;178:1274-82. DOI: https://doi.org/10.1128/jb.178.5.1274-1282.1996
Andersen P, Munk ME, Pollock JM, Doherty TM. Specific immune-based diagnosis of tuberculosis. Lancet 2000;356:1099-104. DOI: https://doi.org/10.1016/S0140-6736(00)02742-2
Prevention Committee of the Japanese Society for Tuberculosis. Guidelines for using QuantiFERON® TB Gold In-Tube August 2011. Kekkaku 2013;88:33-7.
Brock I, Weldingh K, Leyten EM, et al. Specific T-cell epitopes for immunoassay-based diagnosis of Mycobacterium tuberculosis infection. J Clin Microbiol 2004;42:2379-87. DOI: https://doi.org/10.1128/JCM.42.6.2379-2387.2004
Whitworth HS, Scott M, Connell DW, et al. IGRAs--the gateway to T cell based TB diagnosis. Methods 2013;61:52-62. DOI: https://doi.org/10.1016/j.ymeth.2012.12.012
QIAGEN GmbH. QuantiFERON-TB Gold Plus, ELISA Package Insert. Available from: https://www.quantiferon.com/wp-content/uploads/2017/04/English_QFTPlus_ELISA_R04_022016.pdf.
Haas MK, Belknap RW. Diagnostic tests for latent TB infection. Clin Chest Med 2019;40:829-37. DOI: https://doi.org/10.1016/j.ccm.2019.07.007
Manuel O, Kumar D. QuantiFERON-TB Gold assay for the diagnosis of latent tuberculosis infection. Expert Rev Mol Diagn 2008;8:247-56. DOI: https://doi.org/10.1586/14737159.8.3.247
Lalvani A, Pathan AA, McShane H, et al. Rapid detection of Mycobacterium tuberculosis infection by enumeration of antigen-specific T cells. Am J Respir Crit Care Med 2001;163:824-8. DOI: https://doi.org/10.1164/ajrccm.163.4.2009100
Lalvani A, Pathan AA, Durkan H, et al. Enhanced contact tracing and spatial tracking of Mycobacterium tuberculosis infection by enumeration of antigen-specific T cells. Lancet 2001;357:2017-21. DOI: https://doi.org/10.1016/S0140-6736(00)05115-1
Revvity. T-SPOT technology (ELISPOT). Available from: https://www.oxfordimmunotec.com/international/products-services/t-cell-select/.
Li J, Liu Y, Ma L, et al. The performance of T-cell Xtend reagent in increasing blood storage times for interferon gamma release assays. J Clin Lab Anal 2018;32:e22253. DOI: https://doi.org/10.1002/jcla.22253
WHO. WHO operational handbook on tuberculosis. Module 3: diagnosis. Tests for TB infection. 2022. Available from: https://iris.who.int/bitstream/handle/10665/363237/9789240058361-eng.pdf.
WHO. ELISA-based WANTAI TB-IGRA. Available from: https://tbksp.org/en/node/2427.
WHO. Use of alternative interferon-gamma release assays for the diagnosis of TB infection. WHO policy statement. Available from: https://iris.who.int/bitstream/handle/10665/351180/9789240042360-eng.pdf.
Mori T, Sakatani M, Yamagishi F, et al. Specific detection of tuberculosis infection: an interferon-gamma-based assay using new antigens. Am J Respir Crit Care Med 2004;170:59-64. DOI: https://doi.org/10.1164/rccm.200402-179OC
Pai M, Zwerling A, Menzies D. Systematic review: T-cell-based assays for the diagnosis of latent tuberculosis infection: an update. Ann Intern Med 2008;149:177-84. DOI: https://doi.org/10.7326/0003-4819-149-3-200808050-00241
Diel R, Goletti D, Ferrara G, et al. Interferon-γ release assays for the diagnosis of latent Mycobacterium tuberculosis infection: a systematic review and meta-analysis. Eur Respir J 2011;37:88-99. DOI: https://doi.org/10.1183/09031936.00115110
Lalvani A, Berrocal-Almanza LC, Halliday A. Predicting progression to active tuberculosis: A rate-limiting step on the path to elimination. PLoS Med 2019;16:e1002814. DOI: https://doi.org/10.1371/journal.pmed.1002814
Sotgiu G, Saderi L, Petruccioli E, et al. QuantiFERON TB Gold Plus for the diagnosis of tuberculosis: a systematic review and meta-analysis. J Infect 2019;79:444-53. DOI: https://doi.org/10.1016/j.jinf.2019.08.018
Pourakbari B, Mamishi S, Benvari S, Mahmoudi S. Comparison of the QuantiFERON-TB Gold Plus and QuantiFERON-TB Gold In-Tube interferon-γ release assays: a systematic review and meta-analysis. Adv Med Sci 2019;64:437-43. DOI: https://doi.org/10.1016/j.advms.2019.09.001
Xu Y, Yang Q, Zhou J, et al. Comparison of QuantiFERON-TB gold in-tube and QuantiFERON-TB gold-plus in the diagnosis of Mycobacterium tuberculosis infections in immunocompromised patients: a real-world study. Microbiol Spectr 2022;10:e0187021. DOI: https://doi.org/10.1128/spectrum.01870-21
Darmawan G, Liman LMS, Hamijoyo L, et al. Comparison of interferon-gamma production between TB1 and TB2 tubes of QuantiFERON-TB Gold Plus: a meta-analysis. Clin Chem Lab Med 2023;61:2067-75. DOI: https://doi.org/10.1515/cclm-2023-0293
Venkatappa TK, Punnoose R, Katz DJ, et al. Comparing QuantiFERON-TB gold plus with other tests to diagnose Mycobacterium tuberculosis Infection. J Clin Microbiol 2019;57:e00985-19. DOI: https://doi.org/10.1128/JCM.00985-19
Gupta RK, Lipman M, Jackson C, et al. Quantitative IFN-γ release assay and tuberculin skin test results to predict incident tuberculosis. a prospective cohort study. Am J Respir Crit Care Med 2020;201:984-91 DOI: https://doi.org/10.1164/rccm.201905-0969OC
WHO. Consensus meeting report: development of a target product profile (TPP) and a framework for evaluation for a test for predicting progression from tuberculosis infection to active disease. Available from: http://www.who.int/iris/handle/10665/259176.
Rangaka MX, Wilkinson KA, Seldon R, et al. Effect of HIV-1 infection on T-Cell-based and skin test detection of tuberculosis infection. Am J Respir Crit Care Med 2007;175:514.20. DOI: https://doi.org/10.1164/rccm.200610-1439OC
Stephan C, Wolf T, Goetsch U, et al. Comparing QuantiFERON tuberculosis gold, T-SPOT tuberculosis and tuberculin skin test in HIV-infected individuals from a low prevalence tuberculosis country. AIDS 2008;22:2471-9. DOI: https://doi.org/10.1097/QAD.0b013e3283188415
Leidl L, Mayanja-Kizza H, Sotgiu G, et al. Relationship of immunodiagnostic assays for tuberculosis and numbers of circulating CD4+ T-cells in HIV infection. Eur Respir J 2010;35:619-26 DOI: https://doi.org/10.1183/09031936.00045509
Cattamanchi A, Smith R, Steingart KR, 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;56:230-8. DOI: https://doi.org/10.1097/QAI.0b013e31820b07ab
Laboratory Procedure Manual. Tuberculosis (TB) QUANTIFERON gold plus (Interferon-gamma). Available from: https://www.quantiferon.com/wp-content/uploads/2017/04/English_QFTPlus_ELISA_R04_022016.pdf.
Belknap R, Daley CL. Interferon-gamma release assays. Clin Lab Med 2014;34:337-49. DOI: https://doi.org/10.1016/j.cll.2014.02.007
Pagaduan JV, Altawallbeh G. Advances in TB testing. Adv Clin Chem 2023;115:33-62. DOI: https://doi.org/10.1016/bs.acc.2023.03.003
Revvity. T-SPOT technology (ELISPOT). Available from: https://www.oxfordimmunotec.com/international/wp-content/uploads/sites/3/Final-File-PI-TB-US-V6.pdf.
Testing for TB infection video: tuberculin skin test & IGRA blood test Available from: https://www.michigan.gov/-/media/Project/Websites/mdhhs/Folder2/Folder90/Folder1/Folder190/6_Participant_Guide_Testing_for_TB_Infection_Video_-_2017.pdf?rev=65b6c1708ee14792ab6467636d22e4f1.
WHO. South-East Asia immunizes a record-high number of children in 2024. Available from: http://www.searo.who.int/india/mediacentre/events/2014/stci_book.pdf.
Pai M, Rodrigues C. Management of latent tuberculosis infection: An evidence-based approach. Lung India 2015;32:205-7. DOI: https://doi.org/10.4103/0970-2113.156210
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. DOI: https://doi.org/10.1183/09031936.00114810
van Ingen J, de Zwaan R, Dekhuijzen R, et al. Region of difference 1 in nontuberculous Mycobacterium species adds a phylogenetic and taxonomical character. J Bacteriol 2009;191:5865-7. DOI: https://doi.org/10.1128/JB.00683-09
Behr MA, Wilson MA, Gill WP, et al. Comparative genomics of BCG vaccines by whole-genome DNA microarray. Science 1999;284:1520-3. DOI: https://doi.org/10.1126/science.284.5419.1520
de Visser V, Sotgiu G, Lange C, et al. False-negative interferon-γ release assay results in active tuberculosis: a TBNET study. Eur Respir J 2015;45:279-83. DOI: https://doi.org/10.1183/09031936.00120214
Kobashi Y, Shimizu H, Ohue Y, et al. False negative results of QuantiFERON TB-2G test in patients with active tuberculosis. Jpn J Infect Dis 2009;62:300-2. DOI: https://doi.org/10.7883/yoken.JJID.2009.300
Kobashi Y, Mouri K, Yagi S, et al. Clinical utility of the QuantiFERON TB-2G test for elderly patients with active tuberculosis. Chest 2008;133:1196-1202. DOI: https://doi.org/10.1378/chest.07-1995
Hang NT, Lien LT, Kobayashi N, et al. Analysis of factors lowering sensitivity of interferon-γ release assay for tuberculosis. PLoS One 2011;6:e23806. DOI: https://doi.org/10.1371/journal.pone.0023806
Yamasue M, Komiya K, Usagawa Y, et al. Factors associated with false negative interferon-γ release assay results in patients with tuberculosis: a systematic review with meta-analysis. Sci Rep 2020;10:1607. DOI: https://doi.org/10.1038/s41598-020-58459-9
Wang MS, Liu XJ. Risk factors for false-negative interferon-γ release assay results in culture-confirmed childhood TB. Am J Trop Med Hyg 2019;101:1303-7. DOI: https://doi.org/10.4269/ajtmh.18-0684
Overton K, Varma R, Post JJ. Comparison of interferon-γ release assays and the tuberculin skin test for diagnosis of tuberculosis in human immunodeficiency virus: a systematic review. Tuberc Respir Dis 2018;81:59-72. DOI: https://doi.org/10.4046/trd.2017.0072
Zhou G, Luo Q, Luo S, et al. Indeterminate results of interferon gamma release assays in the screening of latent tuberculosis infection: a systematic review and meta-analysis. Front Immunol 2023;14:1170579. DOI: https://doi.org/10.3389/fimmu.2023.1170579
Diel R, Loddenkemper R, Nienhaus A. Evidence-based comparison of commercial interferon-gamma release assays for detecting active TB: a metaanalysis. Chest 2010;137:952-68. DOI: https://doi.org/10.1378/chest.09-2350
Zrinski Topić R, Zoričić-Letoja I, Pavić I, Dodig S. Indeterminate results of QuantiFERON-TB gold in-tube assay in nonimmunosuppressed children. Arch Med Res 2011;42:138-43. DOI: https://doi.org/10.1016/j.arcmed.2011.02.001
Sun X, Wan S, Zhang L, et al. Prevalence and influencing factors of the high nil-control spot count in T-SPOT.TB: A matched case-control study. Clin Chim Acta 2018;487:96-100. DOI: https://doi.org/10.1016/j.cca.2018.09.012
Ward JD, Cornaby C, Schmitz JL. Indeterminate QuantiFERON gold plus results reveal deficient interferon gamma responses in severely ill COVID-19 patients. J Clin Microbiol 2021;59:e0081121. DOI: https://doi.org/10.1128/JCM.00811-21
Banach DB, Harris TG. Indeterminate QuantiFERON®-TB Gold results in a public health clinic setting. Int J Tuberc Lung Dis 2011;15:1623-30. DOI: https://doi.org/10.5588/ijtld.11.0017
Sharninghausen JC, Shapiro AE, Koelle DM, Kim HN. Risk factors for indeterminate outcome on interferon gamma release assay in non-US-born persons screened for latent tuberculosis infection. Open Forum Infect Dis 2018;5:ofy184. DOI: https://doi.org/10.1093/ofid/ofy184
Kobashi Y, Mouri K, Obase Y, et al. Clinical evaluation of QuantiFERON TB-2G test for immunocompromised patients. Eur Respir J 2007;30:945-50. DOI: https://doi.org/10.1183/09031936.00040007
Redelman-Sidi G, Sepkowitz KA. IFN-γ release assays in the diagnosis of latent tuberculosis infection among immunocompromised adults. Am J Respir Crit Care Med 2013;188:422-31. DOI: https://doi.org/10.1164/rccm.201209-1621CI
Gualano G, Mencarini P, Lauria FN, et al. Tuberculin skin test - Outdated or still useful for Latent TB infection screening? Int J Infect Dis 2019;80S:S20-2. DOI: https://doi.org/10.1016/j.ijid.2019.01.048
Ewer K, Deeks J, Alvearez L, et al. Longitudinal tracking of M. tuberculosis-specific T cells ex vivo in latently infected, tuberculin skin test-negative tuberculosis contacts. In: Tuberculosis: integrating host and pathogen biology. Keystone Symposia 2003 Abstract Book; Abstract 317. Silverthorne, CO: Keystone Symposia
Herrera V, Perry S, Parsonnet J, Banaei N. Clinical application and limitations of interferon-gamma release assays for the diagnosis of latent tuberculosis infection. Clin Infect Dis 2011;52:1031-7. DOI: https://doi.org/10.1093/cid/cir068
Joshi M, Monson TP, Joshi A, Woods GL. IFN-γ release assay conversions and reversions. Challenges with serial testing in U.S. health care workers. Ann Am Thorac Soc 2014;11:296-302. DOI: https://doi.org/10.1513/AnnalsATS.201310-378OC
Pai M, Joshi R, Dogra S, et al. Serial testing of health care workers for tuberculosis using interferon-gamma assay. Am J Respir Crit Care Med 2006;174:349-55. DOI: https://doi.org/10.1164/rccm.200604-472OC
Thanassi W, Noda A, Hernandez B, et al. Delineating a Retesting Zone Using Receiver Operating Characteristic Analysis on Serial QuantiFERON Tuberculosis Test Results in US Healthcare Workers. Pulm Med 2012;2012:291294. DOI: https://doi.org/10.1155/2012/291294
Dorman SE, Belknap R, Graviss EA, et al. Interferon-γ release assays and tuberculin skin testing for diagnosis of latent tuberculosis infection in healthcare workers in the United States. Am J Respir Crit Care Med 2014;189:77-87. DOI: https://doi.org/10.1164/rccm.201302-0365OC
Pollock NR, McAdam AJ, Pai M, et al. Interferon γ-release assays for diagnosis of latent tuberculosis in healthcare workers in low-incidence settings: pros and cons. Clin Chem 2014;60:714-8. DOI: https://doi.org/10.1373/clinchem.2012.201178
van Zyl-Smit RN, Zwerling A, Dheda K, Pai M. Within-subject variability of interferon-g assay results for tuberculosis and boosting effect of tuberculin skin testing: a systematic review. PLoS One 2009;4:e857. DOI: https://doi.org/10.1371/journal.pone.0008517
Pai M, Denkinger CM, Kik SV, et al. Gamma interferon release assays for detection of Mycobacterium tuberculosis infection. Clin Microbiol Rev 2014;27:3-20. DOI: https://doi.org/10.1128/CMR.00034-13
Banaei N, Gaur RL, Pai M. Interferon gamma release assays for latent tuberculosis: what are the sources of variability? J Clin Microbiol 2016;54:845-50. DOI: https://doi.org/10.1128/JCM.02803-15
Menzies D. Use of interferon-gamma release assays for diagnosis of tuberculosis infection (tuberculosis screening) in adults. Available from: https://www.uptodate.com/contents/use-of-interferon-gamma-release-assays-for-diagnosis-of-tuberculosis-infection-tuberculosis-screening-in-adults.
Doberne D, Gaur RL, Banaei N. Preanalytical delay reduces sensitivity of QuantiFERON-TB gold in-tube assay for detection of latent tuberculosis infection. J Clin Microbiol 2011;49:3061-4. DOI: https://doi.org/10.1128/JCM.01136-11
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. DOI: https://doi.org/10.1513/AnnalsATS.201405-188OC
Pai M, Banaei N. Occupational screening of health care workers for tuberculosis infection: tuberculin skin testing or interferon-γ release assays? Occup Med 2013;63:458-60. DOI: https://doi.org/10.1093/occmed/kqt105
Canadian Tuberculosis Committee (CTC). Updated recommendations on interferon gamma release assays for latent tuberculosis infection. An Advisory Committee Statement (ACS). Can Commun Dis Rep 2008;34:1-13.
Tuberculosis blood test: interferon gamma release assay (IGRA). Available from: https://www.dhs.wisconsin.gov/publications/p01182.pdf.
Lee SW, Oh DK, Lee SH, et al. Time interval to conversion of interferon-gamma release assay after exposure to tuberculosis. Eur Respir J 2011;37:1447-52. DOI: https://doi.org/10.1183/09031936.00089510
Weinberg A, Aaron L, Montepiedra G, et al. Effects of pregnancy and isoniazid preventive therapy on mycobacterium tuberculosis interferon gamma response assays in women with HIV. Clin Infect Dis 2021;73:e3555-62. DOI: https://doi.org/10.1093/cid/ciaa1083
Silverman MS, Reynolds D, Kavsak PA, et al. Use of an interferon-gamma based assay to assess bladder cancer patients treated with intravesical BCG and exposed to tuberculosis. Clin Biochem 2007;40:913-5. DOI: https://doi.org/10.1016/j.clinbiochem.2007.04.006
WHO. Rapid communication: TB antigen-based skin tests for the diagnosis of TB infection. Available from: https://www.who.int/publications/i/item/WHO-UCN-TB-2022.1.
Ruhwald M, Aggerbeck H, Gallardo RV, et al. Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon γ release assay and the tuberculin skin test: a phase 3, double-blind, randomised, controlled trial. Lancet Respir Med 2017;5:259-68. DOI: https://doi.org/10.1016/S2213-2600(16)30436-2
Aggerbeck H, Giemza R, Joshi P, et al. Randomised clinical trial investigating the specificity of a novel skin test (C-Tb) for diagnosis of M. tuberculosis infection. PLoS One 2013;8:e64215. DOI: https://doi.org/10.1371/journal.pone.0064215
Hamada Y, Cirillo DM, Matteelli A, et al. Tests for tuberculosis infection: landscape analysis. Eur Respir J 2021;58:2100167. DOI: https://doi.org/10.1183/13993003.00167-2021
Hoff ST, Peter JG, Theron G, et al. Sensitivity of C-Tb: a novel RD-1-specific skin test for the diagnosis of tuberculosis infection. Eur Respir J 2016;47:919-28. DOI: https://doi.org/10.1183/13993003.01464-2015
Starshinova A, Dovgalyk I, Malkova A, et al. Recombinant tuberculosis allergen (Diaskintest®) in tuberculosis diagnostic in Russia (meta-analysis). Int J Mycobacteriol 2020;9:335-46. DOI: https://doi.org/10.4103/ijmy.ijmy_131_20
Zhang H, Wang L, Li F, et al. Induration or erythema diameter not less than 5 mm as results of recombinant fusion protein ESAT6-CFP10 skin test for detecting M. tuberculosis infection. BMC Infect Dis 2020;20:685. DOI: https://doi.org/10.1186/s12879-020-05413-9
Xu M, Lu W, Li T, et al. Sensitivity, specificity, and safety of a novel ESAT6-CFP10 skin test for tuberculosis infection in China: 2 randomized, self-controlled, parallel-group phase 2b trials. Clin Infect Dis 2022;74:668-77. DOI: https://doi.org/10.1093/cid/ciab472
DiaSorin. LIAISON® QuantiFERON®-TB Gold Plus ([REF] 311020). Avaialable from: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180047D.pdf.
Fernández-Huerta M, Moreto C, Vila-Olmo N, et al. Evaluation of the fully automated chemiluminescence analyzer liaison XL for the performance of the QuantiFERON-TB gold plus assay in an area with a low incidence of tuberculosis. J Clin Microbiol 2021;59:e0060321. DOI: https://doi.org/10.1128/JCM.00603-21
Bisognin F, Lombardi G, Re MC, Dal Monte P. QuantiFERON-TB gold plus with chemiluminescence immunoassay: do we need a higher cutoff? J Clin Microbiol 2020;58:e00780-20. DOI: https://doi.org/10.1128/JCM.00780-20
Kobashi Y. Current status and future landscape of diagnosing tuberculosis infection. Respir Investig 2023;61:563-78. DOI: https://doi.org/10.1016/j.resinv.2023.04.010
Altawallbeh G, Gabrielson D, Peters JM, Killeen AA. Performance of an advanced interferon-gamma release assay for Mycobacterium tuberculosis detection. J Appl Lab Med 2021;6:1287-92. DOI: https://doi.org/10.1093/jalm/jfab012
Buron V, Banaei N. Inflated gamma interferon response with QuantiFERON-TB gold plus using the automated liaison XL analyzer: a testing algorithm to mitigate false-positive results in low-incidence settings. J Clin Microbiol 2023;61:e0029523. DOI: https://doi.org/10.1128/jcm.01067-23
Saluzzo F, Mantegani P, Poletti de Chaurand V, Cirillo DM. QIAreach QuantiFERON-TB for the diagnosis of Mycobacterium tuberculosis infection. Eur Respir J 2022;59:2102563. DOI: https://doi.org/10.1183/13993003.02563-2021
Stieber F, Howard J, Manissero D, et al. Evaluation of a lateral-flow nanoparticle fluorescence assay for TB infection diagnosis. Int J Tuberc Lung Dis 2021;25:917-22. DOI: https://doi.org/10.5588/ijtld.21.0391
Aziz ZA, Noordin NM, Wan Mohd WM, Kasim MA. First evaluation of the performance of portable IGRA, QIAreach® QuantiFERON®-TB in intermediate TB incidence setting. PLoS One 2023;18:e0279882. DOI: https://doi.org/10.1371/journal.pone.0279882
Mahmoudi S, Nourazar S. Evaluating the diagnostic accuracy of QIAreach QuantiFERON-TB compared to QuantiFERON-TB Gold Plus for tuberculosis: a systematic review and meta-analysis. Sci Rep 2024;14:14455. DOI: https://doi.org/10.1038/s41598-024-65663-4
Diagbouga S, Djibougou AD, Pease C, et al. Preliminary diagnostic performance of the VIDAS® TB-IGRA for the detection of Mycobacterium tuberculosis infection and disease. medRxiv 2022.04.01.22271763. DOI: https://doi.org/10.1101/2022.04.01.22271763
Lionex. LIOFeron®TB/LTBI IGRA. Avaialble from: https://lionex.de/product/lioferon/.
Jungblut PR, Schaible UE, Mollenkopf HJ, et al. Comparative proteome analysis of Mycobacterium tuberculosis and Mycobacterium bovis BCG strains: towards functional genomics of microbial pathogens. Mol Microbiol 1999;33:1103-17. DOI: https://doi.org/10.1046/j.1365-2958.1999.01549.x
Dong Y, Demaria S, Sun X, et al. HLA-A2-restricted CD8+-cytotoxic-T-cell responses to novel epitopes in Mycobacterium tuberculosis superoxide dismutase, alanine dehydrogenase, and glutamine synthetase. Infect Immun 2004;72:2412-5. DOI: https://doi.org/10.1128/IAI.72.4.2412-2415.2004
Tripathi SM, Ramachandran R. Crystal structures of the Mycobacterium tuberculosis secretory antigen alanine dehydrogenase (Rv2780) in apo and ternary complex forms captures "open" and "closed" enzyme conformations. Proteins 2008;72:1089-95. DOI: https://doi.org/10.1002/prot.22101
Della Bella C, Spinicci M, Alnwaisri HFM, et al. LIOFeron®TB/LTBI: a novel and reliable test for LTBI and tuberculosis. Int J Infect Dis 2020;91:177-81. DOI: https://doi.org/10.1016/j.ijid.2019.12.012
Ichroma™ IGRA-TB 25. Available from: https://labindustrias.com/wp-content/uploads/2023/10/INS-TBE-EN-ichroma-IGRA-TB-25_Rev.00_2002111.pdf.
Kweon OJ, Lim YK, Kim HR, et al. Performance evaluation of newly developed fluorescence immunoassay-based interferon-gamma release assay for the diagnosis of latent tuberculosis infection in healthcare workers. J Microbiol Immunol Infect 2022;55:328-31. DOI: https://doi.org/10.1016/j.jmii.2021.05.007
SD Biosensor STANDARD F TB-Feron FIA. Available from: https://www.sdbiosensor.com/product/product_view? product_no=167.
Migliori GB, Ong CWM, Petrone L, et al. The definition of tuberculosis infection based on the spectrum of tuberculosis disease. Breathe 2021;17:210079. DOI: https://doi.org/10.1183/20734735.0079-2021
Kweon OJ, Lim YK, Kim HR, et al. Evaluation of standard E TB-feron enzyme-linked immunosorbent assay for diagnosis of latent tuberculosis infection in health care workers. J Clin Microbiol 2019;57:e01347-19. DOI: https://doi.org/10.1128/JCM.01347-19
Yoo IY, Lee J, Choi AR, et al. Comparative evaluation of standard E TB-Feron ELISA and QuantiFERON-TB gold plus assays in patients with tuberculosis and healthcare workers. Diagnostics 2021;11:1659. DOI: https://doi.org/10.3390/diagnostics11091659
Kim JJ, Park Y, Choi D, Kim HS. performance evaluation of a new automated chemiluminescent immunoanalyzer-based interferon-gamma releasing assay AdvanSure I3 in comparison with the QuantiFERON-TB gold in-tube assay. Ann Lab Med 2020;40:33-39. DOI: https://doi.org/10.3343/alm.2020.40.1.33
TB diagnostics pipeline: needs & solutions by Samuel Schumacher, Deputy Head TB. FIND & NDWG joint symposium, 50th Union World Conference, 30 October 2019. https://www.stoptb.org/sites/default/files/imported/article/oldweb/wg/new_diagnostics/assets/documents/TB_diagnostics_pipeline_needs_and_solutions.pdf.
Ortiz-Brizuela E, Apriani L, Mukherjee T, et al. Assessing the diagnostic performance of new commercial interferon-γ release assays for mycobacterium tuberculosis infection: a systematic review and meta-analysis. Clin Infect Dis 2023;76:1989-99. DOI: https://doi.org/10.1093/cid/ciad030
How to Cite
“Interferon-γ Release Assay”. 2025. Monaldi Archives for Chest Disease, September. https://doi.org/10.4081/monaldi.2025.3258.
Copyright (c) 2025 The Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.