This is not the most recent version of the article. View current version (21 JAN 2014)

Diagnostic Test Accuracy Protocol

You have free access to this content

Xpert MTB/RIF test for detection of pulmonary tuberculosis and rifampicin resistance

  1. Hojoon Sohn2,
  2. Madhukar Pai3,
  3. Nandini Dendukuri4,
  4. Lorie A Kloda5,
  5. Catharina C Boehme6,
  6. Karen R Steingart1,*

Editorial Group: Cochrane Infectious Diseases Group

Published Online: 18 JAN 2012

DOI: 10.1002/14651858.CD009593

How to Cite

Sohn H, Pai M, Dendukuri N, Kloda LA, Boehme CC, Steingart KR. Xpert MTB/RIF test for detection of pulmonary tuberculosis and rifampicin resistance (Protocol). Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD009593. DOI: 10.1002/14651858.CD009593.

Author Information

  1. 1

    University of Washington, School of Public Health, Department of Health Services, Seattle, Washington, USA

  2. 2

    McGill University, Department of Epidemiology & Biostatistics, Montreal, Quebec, Canada

  3. 3

    McGill University, Dept of Epidemiology and Biostatistics, Montreal, QC, Canada

  4. 4

    McGill University, Department of Epidemiology, Biostatistics, and Occupational Health, Montreal, Canada

  5. 5

    McGill University, Life Sciences Library, Montreal, Quebec, Canada

  6. 6

    FIND, Geneva, Switzerland

*Karen R Steingart, Department of Health Services, University of Washington, School of Public Health, Seattle, Washington, 98195-7230, USA. karenst@uw.edu.

Publication History

  1. Publication Status: New
  2. Published Online: 18 JAN 2012

SEARCH

This is not the most recent version of the article. View current version (21 JAN 2014)

References

Additional references

Armand 2011
  • Armand S, Vanhuls P, Delcroix G, Courcol R, Lemaitre N. Comparison of the Xpert MTB/RIF test with an IS6110-TaqMan real-time PCR assay for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. Journal of Clinical Microbiology 2011;49(5):1772-6.
Balshem 2010
  • Balshem H, Helfand M, Schunemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. Journal of Clinical Epidemiology 2010;64(4):401-6.
Banada 2010
  • Banada PP, Sivasubramani SK, Blakemore R, Boehme C, Perkins MD, Fennelly K, et al. Containment of bioaerosol infection risk by the Xpert MTB/RIF assay and its applicability to point-of-care settings. Journal of Clinical Microbiology 2010;48(10):3551-7.
Blakemore 2010
Boehme 2010
Boehme 2011
  • Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, et al. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet 2011;377(9776):1495-505.
Canetti 1963
  • Canetti G, Froman S, Grosset J, Hauduroy P, Langerova M, Mahler HT, et al. Mycobacteria: Laboratory methods for testing drug sensitivity and resistance. Bulletin of the World Health Organization 1963;29:565-78.
Ciftci 2011
  • Ciftci IH, Aslan MH, Asik G. Evaluation of Xpert MTB/RIF results for the detection of Mycobacterium tuberculosis in clinical samples. Mikrobiyoloji Bulteni 2011;45(1):43-7.
Dye 2010
Fendall 1972
Flores 2005
  • Flores LL, Pai M, Colford JM Jr, Riley LW. In-house nucleic acid amplification tests for the detection of Mycobacterium tuberculosis in sputum specimens: meta-analysis and meta-regression. BMC Microbiology 2005;5:55.
Foundation
  • Foundation for Innovative Diagnostics. Automated molecular detection in 90 minutes for tuberculosis and rifampicin resistance. Available from http://www.finddiagnostics.org/export/sites/default/media/press/pdf/XpertTB_factsheet.pdf (accessed 7 March 2011).
Fox 1999
  • Fox W, Ellard G A, Mitchison D A. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council tuberculosis units, 1946-1986, with relevant subsequent publications. International Journal of Tuberculosis and Lung Disease 1999;3(10 Suppl 2):S231-79.
Gatsonis 2006
Getahun 2007
  • Getahun H, Harrington M, O'Brien R, Nunn P. [Diagnosis of smear-negative pulmonary tuberculosis in people with HIV infection or AIDS in resource-constrained settings: informing urgent policy changes]. Lancet 2007;369(9578):2042-9.
Greco 2006
  • Greco S, Girardi E, Navarra A, Saltini C. Current evidence on diagnostic accuracy of commercially based nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis. Thorax 2006;61(9):783-90.
Guyatt 2008
Harbord 2007
Harries 2004
  • Harries A. [16. How does the diagnosis of tuberculosis in persons infected with HIV differ from diagnosis in persons not infected with HIV?]. In: Frieden T editor(s). Toman's Tuberculosis. Case detection, treatment and monitoring - questions and answers. 2nd Edition. Geneva: World Health Organization, 2004:80-3.
Helb 2009
  • Helb D, Jones M, Story E, Boehme C, Wallace E, Ho K, et al. Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology. Journal of Clinical Microbiology 2009;48(1):229-37.
Hesseling 2011
Hillemann 2011
  • Hillemann D, Ruesch-Gerdes S, Boehme C, Richter E. Rapid molecular detection of extrapulmonary tuberculosis by automated GeneXpert(R) MTB/RIF system. Journal of Clinical Microbiology 2011;49(4):1202-5.
Laszlo 1997
  • Laszlo A, Rahman M, Raviglione M, Bustreo F. Quality assurance programme for drug susceptibility testing of Mycobacterium tuberculosis in the WHO/IUATLD Supranational Laboratory Network: first round of proficiency testing. International Journal of Tuberculosis and Lung Disease 1997;1(3):231-8.
Leeflang 2008
  • Leeflang MM, Deeks JJ, Gatsonis C, Bossuyt PM. Systematic reviews of diagnostic test accuracy. Annals of Internal Medicine 2008;149(12):889-97.
Lijmer 2002
Ling 2008
  • Ling DI, Flores LL, Riley LW, Pai M. Commercial nucleic-acid amplification tests for diagnosis of pulmonary tuberculosis in respiratory specimens: meta-analysis and meta-regression. PLoS One 2008;3(2):e1536.
Macaskill 2010
  • Macaskill P, Gatsonis C, Deeks JJ, Harbord RM, Y Takwoingi. [Chapter 10: Analysing and Presenting Results. In: Deeks JJ, Bossuyt PM, C Gatsonis (editors). Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy Version 1.0. The Cochrane Collaboration 2010]. Available from http://srdta.cochrane.org/.
Malbruny 2011
  • Malbruny B, Le Marrec G, Courageux K, Leclercq R, Cattoir V. Rapid and efficient detection of Mycobacterium tuberculosis in respiratory and non-respiratory samples. International Journal of Tuberculosis and Lung Disease 2011;15(4):553-5.
Marais 2010
Marais 2010a
Marlowe 2011
  • Marlowe EM, Novak Weekley SM, Cumpio J, Sharp SE, Momeny MA, Babst A, et al. Evaluation of the Cepheid Xpert MTB/RIF assay for the direct detection of Mycobacterium tuberculosis complex from respiratory specimens. Journal of Clinical Microbiology 2011;49(4):1621-3.
Moher 2009
Moure 2011
  • Moure R, Munoz L, Torres M, Santin M, Martin R, Alcaide F. Rapid detection of Mycobacterium tuberculosis complex and rifampin resistance in smear-negative clinical samples by use of an integrated real-time PCR method. Journal of Clinical Microbiology 2011;49(3):1137-9.
Mugusi 2006
  • Mugusi F, Villamor E, Urassa W, Saathoff E, Bosch RJ, Fawzi WW. HIV co-infection, CD4 cell counts and clinical correlates of bacillary density in pulmonary tuberculosis. International Journal of Tuberculosis and Lung Disease 2006;10(6):663-9.
Pai 2004
  • Pai M, McCulloch M, Enanoria W, Colford JM Jr. Systematic reviews of diagnostic test evaluations: what's behind the scenes?. ACP Journal Club 2004;141(1):A11-3.
Pai 2010
  • Pai M, Minion J, Steingart K, Ramsay A. New and improved tuberculosis diagnostics: evidence, policy, practice, and impact. Current Opinion in Pulmonary Medicine 2010;16(3):271-84.
Pai 2010a
  • Pai M, Minion J, Steingart K, Ramsay A. New and improved tuberculosis diagnostics: evidence, policy, practice, and impact. Current Opinion in Pulmonary Medicine 2010;16(3):271-84.
Perkins 2002
Perkins 2006
Perkins 2007
Raja 2005
  • Raja S, Ching J, Xi L, Hughes SJ, Chang R, Wong W, et al. Technology for automated, rapid, and quantitative PCR or reverse transcription-PCR clinical testing. Clinical Chemistry 2005;51(5):882-90.
Ramsay 2010
  • Ramsay A, Steingart KR, Pai M. Assessing the impact of new diagnostics on tuberculosis control. International Journal of Tuberculosis and Lung Disease 2010;14(12):1506-7.
Reitsma 2005
  • Reitsma JB, Glas AS, Rutjes AW, Scholten RJ, Bossuyt PM, Zwinderman AH. Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. Journal of Clinical Epidemiology 2005;58(10):982-90.
Reitsma 2009
  • Reitsma JB, Rutjes AWS, Whiting P, Vlassov VV, Leeflang MMG, Deeks JJ. Chapter 9: Assessing methodological quality. In: Deeks JJ, Bossuyt PM, Gatsonis C (editors). Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy Version 1.0. The Cochrane Collaboration 2010. Available from: http://srdta.cochrane.org/.
Review Manager 5
  • The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.0. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008.
Rutter 2001
Schünemann 2008
  • Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008;336(7653):1106-10.
Schünemann 2011
  • Schünemann HJ, Oxman AD, Gunn EV, Higgins JPT, Deeks JL, Glasziou P, et al. [Chapter 11. Presenting results and "Summary of findings" tables. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2. The Cochrane Collaboration 2011]. Available from www.cochrane-handbook.org.
Small 2011
Spiegelhalter 2004
  • Spiegelhalter D, Thomas A, Best N, Lunn D. WinBUGS user manual, Version 1.4.1. Available from http://www.mrc-bsu.cam.ac.uk/bugs.
Stata 2009
  • StataCorp. Stata Statistical Software: Release 11. College Station, TX: StataCorp LP, 2009.
Steingart 2006
  • Steingart KR, Ng V, Henry M, Hopewell PC, Ramsay A, Cunningham J, et al. Sputum processing methods to improve the sensitivity of smear microscopy for tuberculosis: a systematic review. Lancet Infectious Disease 2006;6(10):664-74.
Steingart 2007
  • Steingart KR, Henry M, Laal S, Hopewell P C, Ramsay A, Menzies D, et al. A systematic review of commercial serological antibody detection tests for the diagnosis of extrapulmonary tuberculosis. Thorax 2007;62(10):911-8.
Tatsioni 2005
  • Tatsioni A, Zarin DA, Aronson N, Samson DJ, Flamm CR, Schmid C, et al. Challenges in systematic reviews of diagnostic technologies. Annals of Internal Medicine 2005;142(12 Pt 2):1048-55.
Telenti 1993
Traore 2000
  • Traore H, Fissette K, Bastian I, Devleeschouwer M, Portaels F. Detection of rifampicin resistance in Mycobacterium tuberculosis isolates from diverse countries by a commercial line probe assay as an initial indicator of multidrug resistance. International Journal of Tuberculosis and Lung Disease 2000;4(5):481-4.
Van Rie 2010
  • Van Rie A, Page-Shipp L, Scott L, Sanne I, Stevens W. Xpert((R)) MTB/RIF for point-of-care diagnosis of TB in high-HIV burden, resource-limited countries: hype or hope?. Expert Review of Molecular Diagnostics 2010;10(7):937-46.
Whiting 2003
  • Whiting P, Rutjes AW, Reitsma JB, Bossuyt PM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Medical Research Methodology 2003;3:25.
WHO 2008
  • World Health Organization. Policy guidance on drug-susceptibility testing (DST) of second-line antituberculosis drugs. Available at http://www.who.int/tb/publications/2008/whohtmtb_2008_392/en/index.html.. Geneva: WHO, 2008.
WHO 2009
  • World Health Organization. Treatment of tuberculosis: guidelines - 4th edition. Available at http://whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf.. Geneva: World Health Organization, 2009 (accessed 8 June 2011).
WHO 2010
  • [World Bank List of Economies]. Available: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS. 2010 (accessed 7 June 2011).
WHO 2010a
  • World Health Organization. Global tuberculosis control: WHO report 2010. Geneva: World Health Organization, 2010; Vol. WHO/HTM/TB/2010.7.
WHO 2010b
  • World Health Organization. Roadmap for rolling out Xpert MTB/RIF for rapid diagnosis of TB and MDR-TB. Available at http://www.who.int/tb/laboratory/roadmap_xpert_mtb-rif.pdf 2010 (accessed 6 March 2011).
WHO 2010c
  • World Health Organization. Multidrug and extensively drug-resistant TB (M/XDR-TB): 2010 global report on surveillance and response.. 2010;WHO/HTM/TB/2010.3.
WHO 2010d
  • World Health Organization. WHO endorses new rapid tuberculosis test.. Available at http://www.who.int/tb/features_archive/new_rapid_test/en/index.html 2010 (accessed 7 March 2011).
WHO 2011
  • World Health Organization. Rapid implementation of the Xpert MTB/RIF diagnostic test. Technical and Operational "How-to" Practical Considerations. Available at http://whqlibdoc.who.int/publications/2011/9789241501569_eng.pdf 2011.
WHO 2011a
  • World Health Organization. Global tuberculosis control: WHO report. WHO; Geneva 2011:WHO/HTM/TB/2011.16.