QuantiFERON-TB Gold PLUS versus QuantiFERON- TB Gold In-Tube test for diagnosing tuberculosis infection
1
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
Background/Aims: QuantiFERON-TB Gold PLUS (QFT-PLUS) was developed as a new version of the interferon-γ (IFN-γ) release assay that contains an extra antigen tube to elicit a CD8+ T-cell response in addition to a CD4+ T-cell response. This study aimed to evaluate the performances of QFT-PLUS versus QuantiFERON-TB Gold In-Tube (QFT-GIT) for detecting tuberculosis (TB) infection. Methods: Between October, 2016 and May, 2018, 137 participants were prospectively recruited and subjected to QFT-GIT and QFT-PLUS testing. The concordance between tests and performance based on different immune states and/or TB infection risk were evaluated. Results: The 137 participants were classified as follows: active TB (n = 14), TB contact (n = 14), screening before biologic therapy (n = 85) and other disease (n = 24). The positive results for either test were 100% (n = 14/14), 42.9% (n = 6/14), 15.3% (n = 13/85), and 62.5% (n = 15/24) in each four groups, respectively. The QFT-GIT and QFT-PLUS test results showed good concordance with 91.2% agreement and a Cohen’s κ of 0.807. The good concordance between two tests was also observed in 64 immunocompromised subjects (agreement of 90.6% and a Cohen’s κ of 0.711). The intra-class correlation coefficient for each antigen tube of the QFT-PLUS showed a good correlation with the IFN-γ release of the QFT-GIT (TB1 = 0.912, p < 0.001; TB2 = 0.918, p < 0.001). Conclusions: QFT-PLUS showed highly comparable results to those of QFT-GIT for diagnosing TB infection in South Korea as well as in immunocompromised subjects.
Abstract
Background/Aims: QuantiFERON-TB Gold PLUS (QFT-PLUS) was developed as a new version of the interferon-γ (IFN-γ) release assay that contains an extra antigen tube to elicit a CD8+ T-cell response in addition to a CD4+ T-cell response. This study aimed to evaluate the performances of QFT-PLUS versus QuantiFERON-TB Gold In-Tube (QFT-GIT) for detecting tuberculosis (TB) infection. Methods: Between October, 2016 and May, 2018, 137 participants were prospectively recruited and subjected to QFT-GIT and QFT-PLUS testing. The concordance between tests and performance based on different immune states and/or TB infection risk were evaluated. Results: The 137 participants were classified as follows: active TB (n = 14), TB contact (n = 14), screening before biologic therapy (n = 85) and other disease (n = 24). The positive results for either test were 100% (n = 14/14), 42.9% (n = 6/14), 15.3% (n = 13/85), and 62.5% (n = 15/24) in each four groups, respectively. The QFT-GIT and QFT-PLUS test results showed good concordance with 91.2% agreement and a Cohen’s κ of 0.807. The good concordance between two tests was also observed in 64 immunocompromised subjects (agreement of 90.6% and a Cohen’s κ of 0.711). The intra-class correlation coefficient for each antigen tube of the QFT-PLUS showed a good correlation with the IFN-γ release of the QFT-GIT (TB1 = 0.912, p < 0.001; TB2 = 0.918, p < 0.001). Conclusions: QFT-PLUS showed highly comparable results to those of QFT-GIT for diagnosing TB infection in South Korea as well as in immunocompromised subjects.
참고문헌 (32)
- Global Tuberculosis Report 2017, "World Health Organization", World Health Organization, ~ (2017)
- Getahun H, "Latent Mycobacterium tuberculosis infection", N Engl J Med, 372, pp.2127~2135 (2015)
- Trauer JM, "Risk of active tuberculosis in the five years following infection . . . 15%?", Chest, 149, pp.516~525 (2016)
- Jasmer RM, "Clinical practice. Latent tuberculosis infection", N Engl J Med, 347, pp.1860~1866 (2002)
- Lonnroth K, "Towards tuberculosis elimination : an action framework for low-incidence countries", Eur Respir J, 45, pp.928~952 (2015)
- Goletti D, "Performance of the tuberculin skin test and interferon-γ release assays: an update on the accuracy, cutoff stratification, and new potential immune-based approaches", J Rheumatol Suppl, 91, pp.24~31 (2014)
- van Ingen J, "Region of difference 1 in nontuberculous Mycobacterium species adds a phylogenetic and taxonomical character", J Bacteriol, 191, pp.5865~5867 (2009)
- Santin M, "Interferon-γ release assays for the diagnosis of tuberculosis and tuberculosis infection in HIV-infected adults : a systematic review and meta-analysis", PLoS One, 7, pp.e32482~ (2012)
- Mandalakas AM, "Interferon-gamma release assays and childhood tuberculosis : systematic review and meta-analysis", Int J Tuberc Lung Dis, 15, pp.1018~1032 (2011)
- Rangaka MX, "Predictive value of interferon-γ release assays for incident active tuberculosis : a systematic review and meta-analysis", Lancet Infect Dis, 12, pp.45~55 (2012)
- Brighenti S, "Induction and regulation of CD8+ cytolytic T cells in human tuberculosis and HIV infection", Biochem Biophys Res Commun, 396, pp.50~57 (2010)
- Cooper AM, "Cell-mediated immune responses in tuberculosis", Annu Rev Immunol, 27, pp.393~422 (2009)
- Bruns H, "Anti-TNF immunotherapy reduces CD8+ T cell-mediated antimicrobial activity against Mycobacterium tuberculosis in humans", J Clin Invest, 119, pp.1167~1177 (2009)
- Mazzaccaro RJ, "Cytotoxic T lymphocytes in resistance to tuberculosis", Adv Exp Med Biol, 452, pp.85~101 (1998)
- Lewinsohn DA, "Mycobacterium tuberculosis-specific CD8+ T cells preferentially recognize heavily infected cells", Am J Respir Crit Care Med, 168, pp.1346~1152 (2003)
- Rozot V, "Mycobacterium tuberculosis-specific CD8+ T cells are functionally and phenotypically different between latent infection and active disease", Eur J Immunol, 43, pp.1568~1577 (2013)
- Petruccioli E, "First characterization of the CD4 and CD8 T-cell responses to QuantiFERON-TB Plus", J Infect, 73, pp.588~597 (2016)
- "QuantiFERON-TB Gold Plus (QFT-PLUS), ELISA Package Insert" (2015)[URL]
- Pieterman ED, "A multicentre verification study of the QuantiFERON(®)-TB Gold Plus assay", Tuberculosis, 108, pp.136~142 (2018)
- Petruccioli E, "Analytical evaluation of QuantiFERON-Plus and QuantiFERON-Gold In-tube assays in subjects with or without tuberculosis", Tuberculosis, 106, pp.38~43 (2017)
- Hoffmann H, "Equal sensitivity of the new generation QuantiFERON-TB Gold plus in direct comparison with the previous test version QuantiFERON-TB Gold IT", Clin Microbiol Infect, 22, pp.701~703 (2016)
- Barcellini L, "First evaluation of QuantiFERON-TB Gold Plus performance in contact screening", Eur Respir J, 48, pp.1411~1419 (2016)
- Korea Centers for Disease Control and Prevention, "Korean Guidelines for Tuberculosis" (2017), Korea Centers for Disease Control and Prevention
- Blumberg HM, "American Thoracic Society", Centers for Disease Control and Prevention, Am J Respir Crit Care Med, pp.2003, 167[DOI]
- Metcalfe JZ, "Test variability of the QuantiFERON-TB gold in-tube assay in clinical practice", Am J Respir Crit Care Med, 187, pp.206~211 (2013)
- Yi L, "Evaluation of QuantiFERON-TB Gold Plus for detection of Mycobacterium tuberculosis infection in Japan", Sci Rep, 6, pp.30617~ (2016)
- Telisinghe L, "The sensitivity of the QuantiFERON(®)-TB Gold Plus assay in Zambian adults with active tuberculosis", Int J Tuberc Lung Dis, 21, pp.690~696 (2017)
- Keane J, "Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent", N Engl J Med, 345, pp.1098~1104 (2001)
- Solovic I, "The risk of tuberculosis related to tumour necrosis factor antagonist therapies : a TBNET consensus statement", Eur Respir J, 36, pp.1185~1206 (2010)
- Ryu MR, "Comparative evaluation of QuantiFERON-TB Gold In-Tube and QuantiFERON-TB Gold Plus in diagnosis of latent tuberculosis infection in immunocompromised patients", J Clin Microbiol, 56, pp.e00438-18~ (2018)
- Banaei N, "Interferon gamma release assays for latent tuberculosis : what are the sources of variability", J Clin Microbiol, 54, pp.845~850 (2016)
- Andrews JR, "Serial QuantiFERON testing and tuberculosis disease risk among young children : an observational cohort study", Lancet Respir Med, 5, pp.282~290 (2017)
