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Diagnostic Test Accuracy Review

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Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults

  1. Karen R Steingart1,*,
  2. Hojoon Sohn2,
  3. Ian Schiller3,
  4. Lorie A Kloda4,
  5. Catharina C Boehme5,
  6. Madhukar Pai2,
  7. Nandini Dendukuri2

Editorial Group: Cochrane Infectious Diseases Group

Published Online: 31 JAN 2013

Assessed as up-to-date: 7 SEP 2012

DOI: 10.1002/14651858.CD009593.pub2


How to Cite

Steingart KR, Sohn H, Schiller I, Kloda LA, Boehme CC, Pai M, Dendukuri N. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD009593. DOI: 10.1002/14651858.CD009593.pub2.

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 and Occupational Health, Montreal, Quebec, Canada

  3. 3

    McGill University Health Centre, Department of Clinical Epidemiology, Montreal, Canada

  4. 4

    McGill University, Library, Montreal, Quebec, Canada

  5. 5

    Foundation for Innovative New Diagnostics (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: Edited (no change to conclusions)
  2. Published Online: 31 JAN 2013

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

References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
Boehme 2010a {published data only}
Boehme 2010b {published data only}
Boehme 2010c {published data only}
Boehme 2010d {published data only}
Boehme 2010e {published data only}
Boehme 2011a {published data only}
  • 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.
Boehme 2011b {published data only}
  • 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.
Boehme 2011c {published data only}
  • 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.
Boehme 2011d {published data only}
  • 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.
Boehme 2011e {published data only}
  • 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.
Boehme 2011f {published data only}
  • 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.
Bowles 2011 {published data only}
  • Bowles EC, Freyee B, van Ingen J, Mulder B, Boeree M J, van Soolingen D. Xpert MTB/RIF®, a novel automated polymerase chain reaction-based tool for the diagnosis of tuberculosis. International Journal of Tuberculosis and Lung Disease 2011;15:988-9.
Ciftci 2011 {published data only}
  • 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.
Friedrich 2011 {published data only}
  • Friedrich SO, Venter A, Kayigire XA, Dawson R, Donald PR, Diacon AH. Suitability of Xpert MTB/RIF and genotype MTBDRplus for patient selection for a tuberculosis clinical trial. Journal of Clinical Microbiology 2011;49(8):2827-31.
Hanif 2011 {published data only}
  • Hanif SN, Eldeen HS, Ahmad S, Mokaddas E. GeneXpert MTB/RIF for rapid detection of Mycobacterium tuberculosis in pulmonary and extra-pulmonary samples. International Journal of Tuberculosis and Lung Disease 2011;15(9):1274-5.
Helb 2010 {published data only}
  • 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 2010;48(1):229-37.
Ioannidis 2011 {published data only}
  • Ioannidis P, Papaventsis D, Karabela S, Nikolaou S, Panagi M, Raftopoulou E, et al. Cepheid GeneXpert MTB/RIF assay for Mycobacterium tuberculosis detection and rifampin resistance identification in patients with substantial clinical indications of tuberculosis and smear-negative microscopy results. Journal of Clinical Microbiology 2011;49(8):3068-70.
Lawn 2011 {published data only}
  • Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, et al. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Medicine 2011;8(7):e1001067.
Malbruny 2011 {published data only}
  • 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.
Marlowe 2011 {published data only}
  • Marlowe EM, Novak-Weekley SM, Cumpio J, Sharp SE, Momeny MA, Babst A, et al. Evaluation of the Cepheid Xpert MTB/RIF assay for direct detection of Mycobacterium tuberculosis complex in respiratory specimens. Journal of Clinical Microbiology 2011;49(4):1621-3.
Miller 2011 {published data only}
  • Miller MB, Popowitch EB, Backlund MG, Ager EP. Performance of Xpert MTB/RIF RUO Assay and IS6110 Real-Time PCR for Mycobacterium tuberculosis detection in clinical samples. Journal of Clinical Microbiology 2011;49(10):3458-62.
Moure 2011 {published data only}
  • 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.
Rachow 2011 {published data only}
  • Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K, et al. Rapid and accurate detection of Mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay--a clinical validation study. PLoS One 2011;6(6):e20458.
Scott 2011 {published data only}
  • Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Medicine 2011;8(7):e1001061.
Teo 2011 {published data only}
  • Teo J, Jureen R, Chiang D, Chan D, Lin R. Comparison of two nucleic acid amplification assays, the Xpert MTB/RIF and the amplified Mycobacterium tuberculosis Direct assay, for the detection of Mycobacterium tuberculosis in respiratory and non-respiratory specimens. Journal of Clinical Microbiology 2011;49(10):3659-62.
Theron 2011 {published data only}
  • Theron G, Peter J, van Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. American Journal of Respiratory Critical Care Medicine 2011;184(1):132-40.
Zeka 2011 {published data only}
  • Zeka AN, Tasbakan S, Cavusoglu C. Evaluation of the GeneXpert MTB/RIF assay for the rapid diagnosis of tuberculosis and detection of RIF-resistance in pulmonary and extrapulmonary specimens. Journal of Clinical Micobiology 2011;49(12):4138-41.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
Armand 2011 {published data only}
  • 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.
Blakemore 2011 {published data only}
  • Blakemore R, Nabeta P, Davidow A L, Vadwai V, Tahirli R, Munsamy V, et al. A multi-site assessment of the quantitative capabilities of the Xpert(R) MTB/RIF assay. American Journal of Respiratory Critical Care Medicine 2011;184(9):1076-84.
Causse 2011 {published data only}
  • Causse M, Ruiz P, Gutierrez-Aroca JB, Casal M. Comparison of two molecular methods for rapid diagnosis of extrapulmonary tuberculosis. Journal of Clinical Microbiology 2011;49(8):3065-7.
Friedrich 2011a {published data only}
Hillemann 2011 {published data only}
  • Hillemann D, Rusch-Gerdes S, Boehme C, Richter E. Rapid molecular detection of extrapulmonary tuberculosis by the automated GeneXpert MTB/RIF system. Journal of Clinical Microbiology 2011;49(4):1202-5.
Lawn 2011b {published data only}
  • Lawn SD, Nicol MP. Xpert® MTB/RIF assay: development, evaluation and implementation of a new rapid molecular diagnostic for tuberculosis and rifampicin resistance. Future Microbiology 2011;6(9):1067-82.
Ligthelm 2011 {published data only}
  • Ligthelm LJ, Nicol MP, Hoek KG, Jacobson R, van Helden PD, Marais BJ, et al. Xpert MTB/RIF for rapid diagnosis of tuberculous lymphadenitis from fine-needle-aspiration biopsy specimens. Journal of Clinical Microbiology 2011;49(11):3967-70.
Nicol 2011 {published data only}
  • Nicol MP, Workman L, Isaacs W, Munro J, Black F, Eley B, et al. Accuracy of the Xpert MTB/RIF test for the diagnosis of pulmonary tuberculosis in children admitted to hospital in Cape Town, South Africa: a descriptive study. Lancet Infectious Diseases 2011;11(11):819-24.
Vadwai 2011 {published data only}
  • Vadwai V, Boehme C, Nabeta P, Shetty A, Alland D, Rodrigues C. Xpert MTB/RIF: a new pillar in diagnosis of extrapulmonary tuberculosis?. Journal of Clinical Microbiology 2011;49(7):2540-5.
Van Rie 2010 {published data only}
  • Van Rie A, Page-Shipp L, Scott L, Sanne I, Stevens W. Xpert(®) 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.

References to ongoing studies

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
Dheda 2012 {unpublished data only}
  • Multicentre randomised control trial of point-of-treatment (Clinic-based) Xpert MTB/RIF assay. Ongoing study 7 July 2011.
Luetkemeyer 2012 {unpublished data only}
  • Evaluation of Xpert MTB/RIF assay for the rapid identification of TB and TB rifampin resistance in HIV-infected and HIV-uninfected pulmonary tuberculosis suspects. Ongoing study 24 April 2012.
Peter 2012 {unpublished data only}
  • A randomised control trial of sputum induction, and new and emerging technologies in a high HIV prevalence primary care setting. Ongoing study August 2009.

Additional references

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Andrews 2012
  • Andrews JR, Lawn SD, Rusu C, Wood R, Noubary F, Bender MA, et al. The cost-effectiveness of routine tuberculosis screening with Xpert MTB/RIF prior to initiation of antiretroviral therapy: a model-based analysis. AIDS 2012;26(8):987-95.
Banada 2010
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