Sensitivity of C-Tb: A novel RD-1-specific skin test for the diagnosis of tuberculosis infection

European Respiratory Journal

Volumn 47, Issue 3, 2016, Pages 919-928

  Hoff, Soren T ^b   Peter, Jonathan G ^a   Theron, Grant ^a   Pascoe, Mellissa ^a   Tingskov, Pernille N ^b   Aggerbeck, Henrik ^b   Kolbus, Daniel ^b   Ruhwald, Morten ^b   Andersen, Peter ^b   Dheda, Keertan ^a  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b STATENS SERUM INSTITUT   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; CD4 LYMPHOCYTE COUNT; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE DEFICIENCY; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; MYCOBACTERIUM TUBERCULOSIS TEST KIT; PATIENT SAFETY; PRIORITY JOURNAL; SENSITIVITY ANALYSIS; SENSITIVITY AND SPECIFICITY; SERODIAGNOSIS; SKIN TEST; TUBERCULIN TEST; TUBERCULOSIS; TUBERCULOSIS RAPID TEST; ADOLESCENT; CLINICAL TRIAL; COMPARATIVE STUDY; COMPLICATION; ISOLATION AND PURIFICATION; MICROBIOLOGY; MIDDLE AGED; MYCOBACTERIUM TUBERCULOSIS; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RECEIVER OPERATING CHARACTERISTIC; SOUTH AFRICA; STANDARDS; YOUNG ADULT;

ADOLESCENT; ADULT; COINFECTION; DOUBLE-BLIND METHOD; FEMALE; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; MYCOBACTERIUM TUBERCULOSIS; ROC CURVE; SOUTH AFRICA; TUBERCULIN TEST; TUBERCULOSIS; YOUNG ADULT;

EID: 84959891548     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/13993003.01464-2015     Document Type: Article

References (29)

1. Dheda K, Barry C III, Maartens G. Tuberculosis. Lancet 2015 [in press; DOI: 10.1016/S0140-6736(15)00151-8].
2. Esmail H, Barry CE, Young DB, et al. The ongoing challenge of latent tuberculosis. Philos Trans R Soc Lond B Biol Sci 2014; 369: 20130437.
3. 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: 956-973.
4. Dheda K, Smit R, van Z, et al. T-cell interferon-γ release assays for the rapid immunodiagnosis of tuberculosis: clinical utility in high-burden vs. low-burden settings. Curr Opin Pulm Med 2009; 15: 188-200.
5. Farhat M, Greenaway C, Pai M, et al. False-positive tuberculin skin tests: what is the absolute effect of BCG and non-tuberculous mycobacteria? Int J Tuberc Lung Dis 2006; 10: 1192-1204.
6. Brock I, Munk ME, Kok-Jensen A, et al. Performance of whole blood IFN-γ test for tuberculosis diagnosis based on PPD or the specific antigens ESAT-6 and CFP-10. Int J Tuberc Lung Dis 2001; 5: 462-467.
7. Johnson PD, Stuart RL, Grayson ML, et al. Tuberculin-purified protein derivative-, MPT-64-, and ESAT-6-stimulated gamma interferon responses in medical students before and after Mycobacterium bovis BCG vaccination and in patients with tuberculosis. Clin Diagn Lab Immunol 1999; 6: 934-937.
8. Mori T, Sakatani M, Yamagishi F, et al. Specific detection of tuberculosis infection. Am J Respir Crit Care Med 2004; 170: 59-64.
9. 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.
10. Adams S, Ehrlich R, Baatjies R, et al. Incidence of occupational latent tuberculosis infection in South African healthcare workers. Eur Respir J 2015; 45: 1364-1373.
11. Dheda K, Ruhwald M, Theron G, et al. Point-of-care diagnosis of tuberculosis: past, present and future. Respirology 2013; 18: 217-232.
12. Bergstedt W, Tingskov PN, Thierry-Carstensen B, et al. First-in-man open clinical trial of a combined rdESAT-6 and rCFP-10 tuberculosis specific skin test reagent. PLoS One 2010; 5: e11277.
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 2013; 8: e64215.
14. Wang G-Z. Efficacy and safety of recombinant Mycobacterium tuberculosis ESAT-6 protein for diagnosis of pulmonary tuberculosis: a phase II trial. Med Sci Monit 2013; 19: 969-977.
15. Kiselev VI, Baranovskii PM, Rudykh IV, et al. [Clinical trials of the new skin test Diaskintest for the diagnosis of tuberculosis]. Probl Tuberk Bolezn Legk 2009; 2: 11-16.
16. Schulz KF, Altman DG, Moher D CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med 2010; 7: e1000251.
17. Aggerbeck H, Madsen SM. Safety of ESAT-6. Tuberculosis 2006; 86: 363-373.
18. Andersen P, Munk M, Pollock J, et al. Specific immune-based diagnosis of tuberculosis. Lancet 2000; 356: 1099-1104.
19. Gallant CJ, Cobat A, Simkin L, et al. Tuberculin skin test and in vitro assays provide complementary measures of antimycobacterial immunity in children and adolescents. Chest 2010; 137: 1071-1077.
20. Cobat A, Gallant CJ, Simkin L, et al. Two loci control tuberculin skin test reactivity in an area hyperendemic for tuberculosis. J Exp Med 2009; 206: 2583-2591.
21. Metcalfe JZ, Everett CK, 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: S1120-S1129.
22. Tsiouris SJ, Coetzee D, Toro PL, et al. Sensitivity analysis and potential uses of a novel gamma interferon release assay for diagnosis of tuberculosis. J Clin Microbiol 2006; 44: 2844-2850.
23. Mahomed H, Ehrlich R, Hawkridge T, et al. TB incidence in an adolescent cohort in South Africa. PLoS One 2013; 8: e59652.
24. Botha L, Gey van Pittius NC, van Helden PD. Mycobacteria and disease in Southern Africa. Transbound Emerg Dis 2013; 60: 147-156.
25. 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: 230-238.
26. Elzi L, Schlegel M, Weber R, et al. Reducing tuberculosis incidence by tuberculin skin testing, preventive treatment, and antiretroviral therapy in an area of low tuberculosis transmission. Clin Infect Dis 2007; 44: 94-102.
27. Aabye MG, Ravn P, PrayGod G, et al. The impact of HIV infection and CD4 cell count on the performance of an interferon gamma release assay in patients with pulmonary tuberculosis. PLoS One 2009; 4: e4220.
28. Dheda K, Lalvani A, Miller R, et al. Performance of a T-cell-based diagnostic test for tuberculosis infection in HIV-infected individuals is independent of CD4 cell count. Aids 2005; 19: 2038-2041.
29. Cobelens FG, Egwaga SM, Ginkel T, et al. Tuberculin skin testing in patients with HIV infection: limited benefit of reduced cutoff values. Clin Infect Dis 2006; 43: 634-639.