The diagnostic accuracy of the GenoType® MTBDRsl assay for the detection of resistance to second-line anti-tuberculosis drugs

This paper examines evidence from 21 studies, 11 of which were in low-income or middle-income countries

Abstract

Background

Genotype® MTBDRsl (MTBDRsl) is a rapid DNA-based test for detecting specific mutations associated with resistance to fluoroquinolones and second-line injectable drugs (SLIDs) in Mycobacterium tuberculosis complex. MTBDRsl version 2.0 (released in 2015) identifies the mutations detected by version 1.0, as well as additional mutations. The test may be performed on a culture isolate or a patient specimen, which eliminates delays associated with culture. Version 1.0 requires a smear-positive specimen, while version 2.0 may use a smear-positive or -negative specimen. The authors performed this updated review as part of a World Health Organization process to develop updated guidelines for using MTBDRsl.

Objectives

To assess and compare the diagnostic accuracy of MTBDRsl for: 1. fluoroquinolone resistance, 2. SLID resistance, and 3. extensively drug-resistant tuberculosis, indirectly on a M. tuberculosis isolate grown from culture or directly on a patient specimen. Participants were people with rifampicin-resistant or multidrug-resistant tuberculosis. The role of MTBDRsl would be as the initial test, replacing culture-based drug susceptibility testing (DST), for detecting second-line drug resistance.

This research is supported by the Department for International Development’s Evidence Building and Synthesis Research Programme which is led by Liverpool School of Tropical Medicine

Citation

Theron, G.; Peter, J.; Richardson, M.; Barnard, M.; Donegan, S.; Warren, R.; Steingart, K.R.; Dheda, K. The diagnostic accuracy of the GenoType® MTBDRsl assay for the detection of resistance to second-line anti-tuberculosis drugs. Cochrane Database of Systematic Reviews (2016) [DOI: 10.1002/14651858.CD010705.pub3]

The diagnostic accuracy of the GenoType® MTBDRsl assay for the detection of resistance to second-line anti-tuberculosis drugs

Published 8 September 2016