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Bibliographic Info

Guideline
Year of Publication
Issuing Institution

Recommendation

Status
Maintained

Recommended in favor

Conditional

For patients with confirmed rifampicin-resistant TB (tuberculosis) or MDR-TB (multidrug resistant tuberculosis), SL-LPA (Second-line lineprobe assays) may be used as the initial test, instead of phenotypic culture-based DST (drug-susceptibility testing), to detect resistance to fluoroquinolones

Notes and Remarks

a. These recommendations apply to the use of SL-LPA for testing sputum specimens (direct testing) and cultured isolates of M. tuberculosis complex (indirect testing) from both pulmonary and extrapulmonary sites. Direct testing on sputum specimens allows for the earlier initiation of appropriate treatment; b. These recommendations apply to the direct testing of sputum specimens from rifampicin-resistant TB or MDR-TB, irrespective of the smear status, while acknowledging that the indeterminate rate is higher when testing smear-negative sputum specimens compared with smear-positive sputum specimens; c. These recommendations apply to the diagnosis of XDR-TB while acknowledging that the accuracy for detecting resistance to the fluoroquinolones and to the SLIDs differs and hence the accuracy of a diagnosis of XDR-TB overall is reduced ; d. These recommendations do not eliminate the need for conventional phenotypic DST capacity which will be necessary to confirm resistance to other drugs and to monitor the emergence of additional drug resistance; e. Conventional phenotypic DST can still be used in the evaluation of patients with a negative SL-LPA result, particularly in populations with a high pre-test probability for resistance to fluoroquinolones and/or SLID; f. These recommendations apply to the use of SL-LPA in children with confirmed rifampicinresistant TB or MDR-TB based on the generalisation of data from adults; g. Resistance conferring mutations detected by SL-LPA are highly correlated with phenotypic resistance to ofloxacin and levofloxacin. However, the correlation of these mutations with phenotypic resistance to moxifloxacin and gatifloxacin is unclear and the inclusion of moxifloxacin or gatifloxacin in a MDR-TB regimen is best guided by phenotypic DST results; h. Resistance conferring mutations detected by SL-LPA are highly correlated with phenotypic resistance to SLID and are an indication to use a MDR-TB regimen which is appropriately strengthened; i. Given high specificity for detecting resistance to fluoroquinolones and SLID the positive results of SL-LPA could be used to guide the implementation of appropriate infection control precautions.

Also Featured In

This recommendation also appears in the following guidelines:

Guideline

WHO consolidated guidelines on tuberculosis: module 3: diagnosis – rapid diagnostics for tuberculosis detection: web annex 2. GRADE profiles

Year2020
InstitutionWHO
Guideline

WHO consolidated guidelines on tuberculosis: module 3: diagnosis – rapid diagnostics for tuberculosis detection: web annex 2. GRADE profiles

Year2020
InstitutionWHO
Guideline

WHO consolidated guidelines on tuberculosis: module 3: diagnosis – rapid diagnostics for tuberculosis detection: web annex 2. GRADE profiles

Year2020
InstitutionWHO
Guideline

WHO consolidated guidelines on tuberculosis: module 3: diagnosis: rapid diagnostics for tuberculosis detection, 3rd ed.

Year2024
InstitutionWorld Health Organization
Guideline

WHO consolidated guidelines on tuberculosis: module 3: diagnosis

Year2025
InstitutionWorld Health Organization
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