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Dodd PJ, Gardiner E, Coghlan R, Seddon JA, 2014. Burden of childhood tuberculosis in 22 high-burden countries: a mathematical modelling study. Lancet Glob Health 2: e453–e459.
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Mandalakas AM, Hesseling AC, Gie RP, Schaaf HS, Marais BJ, Sinanovic E, 2013. Modelling the cost-effectiveness of strategies to prevent tuberculosis in child contacts in a high-burden setting. Thorax 68: 247–255.
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Telisinghe L, Amofa-Sekyi M, Maluzi K, Kaluba-Milimo D, Cheeba-Lengwe M, Chiwele K, Kosloff B, Floyd S, Bailey SL, Ayles H, 2017. The sensitivity of the QuantiFERON®-TB Gold Plus assay in Zambian adults with active tuberculosis. Int J Tuberc Lung Dis 21: 690–696.
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Takasaki J, Manabe T, Morino E, Muto Y, Hashimoto M, Iikura M, Izumi S, Sugiyama H, Kudo K, 2018. Sensitivity and specificity of QuantiFERON-TB Gold Plus compared with QuantiFERON-TB Gold In-Tube and T-SPOT.TB on active tuberculosis in Japan. J Infect Chemother 24: 188–192.
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Evaluation of the QuantiFERON-Tuberculosis Gold Plus Assay in Children with Tuberculosis Disease or Following Household Exposure to Tuberculosis
Alexander W. Kay
Alexander W. Kay
Baylor College of Medicine, Houston, Texas;
Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, Texas;
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Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, Texas;
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Andrew R. DiNardo
Andrew R. DiNardo
Baylor College of Medicine, Houston, Texas;
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Qiniso Dlamini
Qiniso Dlamini
Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, Texas;
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Jaqueline Kahari
Jaqueline Kahari
Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, Texas;
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Temhlanga Mndzebele
Temhlanga Mndzebele
Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, Texas;
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Godwin Mtetwa
Godwin Mtetwa
Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, Texas;
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Pilar Ustero
Pilar Ustero
Baylor College of Medicine, Houston, Texas;
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Gugu Maphalala
Gugu Maphalala
Ministry of Health, Mbabane, Eswatini
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Anna M. Mandalakas
Anna M. Mandalakas
Baylor College of Medicine, Houston, Texas;
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Interferon-gamma release assays are increasingly used in children to establish evidence of tuberculosis (TB) infection and to assist in the diagnosis of TB disease. The QuantiFERON-TB Gold In-Tube assay is being phased out in favor of a next-generation test, the QuantiFERON-TB Gold Plus (QFT-Plus) assay. The QFT-Plus assay is designed with two antigen tubes to differentially stimulate CD4+ and CD8+ T cells. The performance of this assay has been documented extensively in adults but has not yet been evaluated in children. Here, we compare the performance of the two assays in a cohort of 46 children exposed to TB and 12 children diagnosed with TB disease in Eswatini. The tests demonstrated excellent concordance in both TB disease (100% agreement, Cohen’s kappa = 1) and TB infection (96% agreement, Cohen’s kappa = 0.91). Most of the children with household exposure tested negative for TB infection by both tests, indicating the ongoing need for new tests for TB infection that can be easily implemented in TB high-burden settings at minimal cost.
Author Notes
Authors’ addresses: Alexander W. Kay, Baylor College of Medicine, Houston, TX, and Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, TX, E-mail: alexander.kay@bcm.edu. Andrew R. DiNardo, Pilar Ustero, and Anna M. Mandalakas, Baylor College of Medicine, Houston, TX, E-mails: andrew.dinardo@bcm.edu, pustero@yahoo.es, and anna.mandalakas@bcm.edu. Qiniso Dlamini, Jaqueline Kahari, Temhlanga Mndzebele, and Godwin Mtetwa, Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, TX, E-mails: qinisod@baylorswaziland.org.sz, jaqkahari@gmail.com, m.temhlanga@gmail.com, and gmtetwa@baylorswaziland.org.sz. Gugu Maphalala, Eswatini Health Laboratory Services, Ministry of Health, Eswatini, E-mail: gpmaph@gmail.com.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Dodd PJ, Gardiner E, Coghlan R, Seddon JA, 2014. Burden of childhood tuberculosis in 22 high-burden countries: a mathematical modelling study. Lancet Glob Health 2: e453–e459.
-
2.
World Health Organization, 2016. The End TB Strategy: Global Strategy and Targets for Tuberculosis Prevention, Care and Control after 2015. Geneva, Switzerland: WHO.
-
3.
World Health Organization, 2017. Global Tuberculosis Report 2017. Geneva, Switzerland: WHO.
-
4.
Mandalakas AM, Hesseling AC, Gie RP, Schaaf HS, Marais BJ, Sinanovic E, 2013. Modelling the cost-effectiveness of strategies to prevent tuberculosis in child contacts in a high-burden setting. Thorax 68: 247–255.
-
5.
National Tuberculosis Controllers Association, Centers for Disease Control and Prevention (CDC), 2005. Guidelines for the investigation of contacts of persons with infectious tuberculosis. Recommendations from the National Tuberculosis Controllers Association and CDC. MMWR. Recomm Rep 54: 1–47.
-
6.
Starke JR; Committee On Infectious Diseases, 2014. Interferon-γ release assays for diagnosis of tuberculosis infection and disease in children. Pediatrics 134: e1763–e1773.
-
7.
Petruccioli E, Vanini V, Chiacchio T, Cuzzi G, Cirillo DM, Palmieri F, Ippolito G, Goletti D, 2017. Analytical evaluation of QuantiFERON- Plus and QuantiFERON- Gold In-tube assays in subjects with or without tuberculosis. Tuberculosis 106: 38–43.
-
8.
Telisinghe L, Amofa-Sekyi M, Maluzi K, Kaluba-Milimo D, Cheeba-Lengwe M, Chiwele K, Kosloff B, Floyd S, Bailey SL, Ayles H, 2017. The sensitivity of the QuantiFERON®-TB Gold Plus assay in Zambian adults with active tuberculosis. Int J Tuberc Lung Dis 21: 690–696.
-
9.
Horne DJ et al. 2018. Multicenter study of QuantiFERON®-TB Gold Plus in patients with active tuberculosis. Int J Tuberc Lung Dis 22: 617–621.
-
10.
Takasaki J, Manabe T, Morino E, Muto Y, Hashimoto M, Iikura M, Izumi S, Sugiyama H, Kudo K, 2018. Sensitivity and specificity of QuantiFERON-TB Gold Plus compared with QuantiFERON-TB Gold In-Tube and T-SPOT.TB on active tuberculosis in Japan. J Infect Chemother 24: 188–192.
-
11.
Pieterman ED et al. 2018. A multicentre verification study of the QuantiFERON®-TB Gold Plus assay. Tuberculosis (Edinb) 108: 136–142.
-
12.
Barcellini L et al. 2016. First evaluation of QuantiFERON-TB Gold Plus performance in contact screening. Eur Respir J 48: 1411–1419.
-
13.
Theel ES et al. 2018. Comparison of the QuantiFERON-TB Gold Plus and QuantiFERON-TB Gold In-Tube interferon gamma release assays in patients at risk for tuberculosis and in health care workers. J Clin Microbiol 56: e00614–e00618.
-
14.
Dieli F et al. 2018. Performance of QuantiFERON-TB Gold Plus for detection of latent tuberculosis infection in pregnant women living in a tuberculosis- and HIV-endemic setting. Plos One 13: e0193589.
-
15.
Petruccioli E et al. 2016. First characterization of the CD4 and CD8 T-cell responses to QuantiFERON-TB Plus. J Infect 73: 588–597.
-
16.
Mandalakas AM, Kirchner HL, Lombard C, Walzl G, Grewal HM, Gie RP, Hesseling AC, 2012. Well-quantified tuberculosis exposure is a reliable surrogate measure of tuberculosis infection. Int J Tuberc Lung Dis 16: 1033–1039.
-
17.
QIAGEN, 2017. QFT Plus ELISA Package Insert. Available at: http://www.quantiferon.com/wp-content/uploads/2017/04/English_QFTPlus_ELISA_R04_022016.pdf.
-
18.
World Health Organization, 2018. Latent Tuberculosis Infection Updated and Consolidated Guidelines for Programmatic Management. Geneva, Switzerland: WHO.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 401 | 294 | 21 |
| Full Text Views | 554 | 16 | 0 |
| PDF Downloads | 236 | 17 | 0 |