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Diagnostic Test Accuracy Protocol

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The GenoType® MTBDRsl test for resistance to second-line anti-tuberculosis drugs

  1. Grant Theron1,*,
  2. Jonny Peter1,
  3. Marinus Barnard2,3,
  4. Sarah Donegan4,
  5. Rob Warren3,
  6. Karen R Steingart5,
  7. Keertan Dheda1

Editorial Group: Cochrane Infectious Diseases Group

Published Online: 22 AUG 2013

DOI: 10.1002/14651858.CD010705


How to Cite

Theron G, Peter J, Barnard M, Donegan S, Warren R, Steingart KR, Dheda K. The GenoType® MTBDRsl test for resistance to second-line anti-tuberculosis drugs (Protocol). Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD010705. DOI: 10.1002/14651858.CD010705.

Author Information

  1. 1

    University of Cape Town, Department of Medicine, Cape Town, Western Cape, South Africa

  2. 2

    National Health Laboratory Service, Cape Town, South Africa

  3. 3

    Stellenbosch University, Matieland, South Africa

  4. 4

    Liverpool School of Tropical Medicine, Department of Clinical Sciences, Liverpool, Merseyside, UK

  5. 5

    Liverpool School of Tropical Medicine, Cochrane Infectious Diseases Group, Liverpool, UK

*Grant Theron, Department of Medicine, University of Cape Town, H47.88, Old Main Building, Groote Schuur Hospital, Cape Town, Western Cape, 7798, South Africa. grant.theron@uct.ac.za.

Publication History

  1. Publication Status: New
  2. Published Online: 22 AUG 2013

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Abstract

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  2. Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To obtain summary estimates of the diagnostic accuracy of GenoType® MTBDRsl for detection of resistance to the fluoroquinolones in patient specimens or culture isolates confirmed as TB positive.

To obtain summary estimates of the diagnostic accuracy of GenoType® MTBDRsl for detection of resistance to second-line injectable drugs in patient specimens or culture isolates confirmed as TB positive.

To obtain summary estimates of the diagnostic accuracy of GenoType® MTBDRsl for detection of XDR-TB in patient specimens or culture isolates confirmed as TB positive.

Purpose of index test: GenoType® MTBDRsl used as an initial test replacing phenotypic culture-based DST as the initial test.

We plan to investigate heterogeneity in relation to the reference tests (genetic sequencing, culture-based DST, and culture-based DST followed by genetic sequencing), as well as by type of testing (indirect or direct). We also plan to investigate heterogeneity in relation to HIV status, conditions of the specimens (fresh or frozen, volume of specimen) and patient population (patients suspected of having MDR-TB or XDR-TB).