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

The Lancet Respiratory Medicine

Volumn 5, Issue 4, 2017, Pages 259-268

  Ruhwald, Morten ^a   Aggerbeck, Henrik ^a   Gallardo, Rafael Vázquez ^d   Hoff, Søren T ^a   Villate, José I ^e   Borregaard, Bettine ^a   Martinez, José A ^m   Kromann, Ingrid ^a   Penas, Antón ^f   Anibarro, Luis L ^g   de Souza Galvão, Maria Luiza ^h   Sánchez, Francisca ⁱ   Rodrigo Pendás, Jose Ángel ^h   Noguera Julian, Antoni ^c,j   Martínez Lacasa, Xavier ^k   Tuñez, Maria Victoria ^l   Fernández, Virginia Leiro ^d   Millet, Joan P ^b,c   Moreno, Antonio ^b,c   Cobos, Nazaret ^m   Miró, José M ^m   Roldan, Llanos ^b   Orcau, Angels ^b,c   Andersen, Peter ^a   Caylá, Joan A ^b,c   more..

^a STATENS SERUM INSTITUT   (Denmark)

^b AGÈNCIA DE SALUT PÚBLICA DE BARCELONA   (Spain)

^c CIBER EPIDEMIOLOGÍA Y SALUD PÚBLICA CIBERESP   (Spain)

^d UNIVERSITY HOSPITAL COMPLEX OF VIGO   (Spain)

^e HOSPITAL DE CRUCES   (Spain)

^f HOSPITAL UNIVERSITARIO LUCUS AUGUSTI   (Spain)

^g Galicia Sur Health Research Institute   (Spain)

^h HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

ⁱ HOSPITAL DEL MAR   (Spain)

^j HOSPITAL SANT JOAN DE DÉU   (Spain)

^k HOSPITAL MÚTUA DE TERRASSA   (Spain)

^l HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

^m UNIVERSITY OF BARCELONA   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

TUBERCULIN; BCG VACCINE;

ADOLESCENT; ARTICLE; C TUBERCULOSIS SKIN TEST; CHILD; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DIAGNOSTIC TEST; DIAGNOSTIC TEST ACCURACY STUDY; DISEASE ASSOCIATION; FEMALE; HUMAN; INFECTION RISK; INTERFERON GAMMA RELEASE ASSAY; MAJOR CLINICAL STUDY; NONHUMAN; PATIENT SAFETY; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; QUANTIFERON TUBERCULOSIS GOLD IN TUBE TEST; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; SCHOOL CHILD; SKIN INDURATION; SKIN TEST; TREND STUDY; TUBERCULIN TEST; TUBERCULOSIS; ADULT; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; IMMUNOLOGY; MALE; MULTICENTER STUDY; MYCOBACTERIUM TUBERCULOSIS; PROCEDURES; SPAIN; YOUNG ADULT;

ADOLESCENT; ADULT; BCG VACCINE; CHILD; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTERFERON-GAMMA RELEASE TESTS; MALE; MYCOBACTERIUM TUBERCULOSIS; SPAIN; TUBERCULIN TEST; TUBERCULOSIS; YOUNG ADULT;

EID: 85011088662     PISSN: 22132600     EISSN: 22132619     Source Type: Journal    
DOI: 10.1016/S2213-2600(16)30436-2     Document Type: Article

References (28)

1. 1 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 33 (2009), 956–973.
2. 2 WHO. Framework towards tuberculosis elimination in low-incidence countries, 2014, World Health Organization, Geneva.
3. 3 Horsburgh, CR, Barry, CE, Lange, C, Treatment of tuberculosis. N Engl J Med 373 (2015), 2149–2160.
4. 4 Lobue, P, Menzies, D, Treatment of latent tuberculosis infection: an update. Respirology 15 (2010), 603–622.
5. 5 Sotgiu, G, Matteelli, A, Getahun, H, et al. Monitoring toxicity in individuals receiving treatment for latent tuberculosis infection: a systematic review versus expert opinion. Eur Respir J 45 (2015), 1170–1173.
6. 6 Huebner, RE, Schein, MF, Bass, JJ, The tuberculin skin test. Clin Infect Dis 17 (1993), 968–975.
7. 7 Harboe, M, Antigens of PPD, old tuberculin, and autoclaved Mycobacterium bovis BCG studied by crossed immunoelectrophoresis. Am Rev Respir Dis 124 (1981), 80–87.
8. 8 Pai, M, Denkinger, CM, Kik, SV, et al. Gamma interferon release assays for detection of Mycobacterium tuberculosis infection. Clin Microbiol Rev 27 (2014), 3–20.
9. 9 WHO. Guidance for national tuberculosis programmes on the management of tuberculosis in children, 2nd edn., 2014, World Health Organization, Geneva.
10. 10 CDC. Fact sheets: tuberculin skin testing. http://www.cdc.gov/tb/publications/factsheets/testing/skintesting.htm, May 11, 2016 (accessed Dec 6, 2016).
11. 11 Zellweger, J-P, Sotgiu, G, Block, M, et al. Risk assessment of tuberculosis in contacts by IFN-γ release assays. A Tuberculosis Network European Trials Group study. Am J Respir Crit Care Med 191 (2015), 1176–1184.
12. 12 Haldar, P, Thuraisingam, H, Patel, H, et al. Single-step QuantiFERON screening of adult contacts: a prospective cohort study of tuberculosis risk. Thorax 68 (2013), 240–246.
13. 13 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, 8, 2013, e64215.
14. 14 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 47 (2016), 919–928.
15. 15 The Contacts Study Group of the Research Unit on Tuberculosis in Barcelona (UITB). Documento de consenso sobre el estudio de contactos en los pacientes tuberculosos. Med Clin (Barc) 112 (1999), 151–156.
16. 16 Grup de Treball. Protocols I circuits de coordinació: guia i proposta d'organització per a la prevenció i control del a tuberculosis a la Regió Sanitària Barcelona. http://www.saveva.com/domamCons/pub/botss/pdf/guia_tuberculos_def.pdf, 2008 (accessed Oct 20, 2016).
17. 17 Diel, R, Loddenkemper, R, Niemann, S, Meywald-Walter, K, Nienhaus, A, Negative and positive predictive value of a whole-blood interferon-γ release assay for developing active tuberculosis: an update. Am J Respir Crit Care Med 183 (2011), 88–95.
18. 18 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 56 (2011), 230–238.
19. 19 Mori, T, Specific detection of tuberculosis infection: an interferon-based assay using new antigens. Am J Respir Crit Care Med 170 (2004), 59–64.
20. 20 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 37 (2011), 100–111.
21. 21 Chegou, NN, Heyckendorf, J, Walzl, G, Lange, C, Ruhwald, M, Beyond the IFN-horizon: biomarkers for immunodiagnosis of infection with Mycobacterium tuberculosis. Eur Respir J 43 (2014), 1472–1486.
22. 22 Sester, U, Fousse, M, Dirks, J, et al. Whole-blood flow-cytometric analysis of antigen-specific CD4 T-cell cytokine profiles distinguishes active tuberculosis from non-active states. PLoS One, 6, 2011, e17813.
23. 23 Lienhardt, C, Lönnroth, K, Menzies, D, et al. Translational research for tuberculosis elimination: priorities, challenges, and actions. PLoS Med, 13, 2016, e1001965.
24. 24 WHO. Guidelines on the management of latent tuberculosis infection, 2015, World Health Organization, Geneva.
25. 25 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 10 (2006), 1192–1204.
26. 26 Pai, M, Sotgiu, G, Diagnostics for latent TB infection: incremental, not transformative progress. Eur Respir J 47 (2016), 704–706.
27. 27 Cunningham, J, Perkins, M, Diagnostics for tuberculosis—global demand and market potential. http://apps.who.int/iris/bitstream/10665/43543/1/9241563303_eng.pdf, 2006 (accessed Dec 6, 2016).
28. 28 Tebruegge, M, Bogyi, M, Soriano-Arandes, A, Kampmann, B, Shortage of purified protein derivative for tuberculosis testing. Lancet, 384, 2014, 2026.