The use of molecular line probe assays for the detection of resistance to second-line anti-tuberculosis drugs: policy guidance
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World Health Organization
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42 p.
This policy guidance presents WHO recommendations on the use of second-line line probe assays (SL-LPA) for the rapid detection of resistance to fluoroquinolones and second-line injectable drugs in patients with rifampicin-resistant or multidrug-resistant tuberculosis (RR-TB/MDR-TB). Developed following a systematic review of the evidence and the WHO guideline development process using the GRADE approach, it evaluates the diagnostic accuracy of the commercially available Genotype® MTBDRsl assay (versions 1.0 and 2.0) for direct testing of sputum specimens and indirect testing of culture isolates. The guidance was produced in response to the need for rapid and reliable detection of second-line drug resistance to support timely treatment decisions, including the use of shorter MDR-TB regimens and newer medicines. The document recommends that SL-LPA may be used as the initial test, in place of phenotypic culture-based drug susceptibility testing, to detect resistance to fluoroquinolones and second-line injectable drugs in patients with confirmed RR-TB or MDR-TB. It also outlines the scope and limitations of the assay, emphasizing that conventional phenotypic drug susceptibility testing remains necessary to confirm resistance to other drugs and monitor emerging resistance. Implementation considerations, intended users and research needs are presented to support adoption of the recommendations within national tuberculosis programmes.
This policy guidance presents WHO recommendations on the use of second-line line probe assays (SL-LPA) for the rapid detection of resistance to fluoroquinolones and second-line injectable drugs in patients with rifampicin-resistant or multidrug-resistant tuberculosis (RR-TB/MDR-TB). Developed following a systematic review of the evidence and the WHO guideline development process using the GRADE approach, it evaluates the diagnostic accuracy of the commercially available Genotype® MTBDRsl assay (versions 1.0 and 2.0) for direct testing of sputum specimens and indirect testing of culture isolates. The guidance was produced in response to the need for rapid and reliable detection of second-line drug resistance to support timely treatment decisions, including the use of shorter MDR-TB regimens and newer medicines. The document recommends that SL-LPA may be used as the initial test, in place of phenotypic culture-based drug susceptibility testing, to detect resistance to fluoroquinolones and second-line injectable drugs in patients with confirmed RR-TB or MDR-TB. It also outlines the scope and limitations of the assay, emphasizing that conventional phenotypic drug susceptibility testing remains necessary to confirm resistance to other drugs and monitor emerging resistance. Implementation considerations, intended users and research needs are presented to support adoption of the recommendations within national tuberculosis programmes.