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Rapid diagnosis of second-line drug resistance in TB
Rapid diagnosis of the gene mutation associated with rifampicin resistance using GeneXpert MTB/RIF has improved the speed of diagnosis of multidrug-resistant TB; however, there are no established rapid techniques to assess for resistance to fluoroquinolones and injectable drugs. Xie et al (N Engl J Med 2017;377:1043–54)have conducted a multicentre, prospective, blinded study in Korea and China to determine the sensitivity and specificity of a GeneXpert compatible assay which detects genes associated with resistance to isoniazid, moxifloxacin, ofloxacin, amikacin and kanamycin. A total of 405 patients were enrolled from June 2014 to June 2015 with 304 suitable samples included in the final analysis. The sensitivity of the assay for detection of Mycobacterium tuberculosis was 98%, which equalled GeneXpert MTB/RIF. The WHO recommended performance for molecular tests of drug resistance is a sensitivity of 95% and specificity of 98%. Sensitivity for resistance gene detection compared with DNA sequencing ranged from 92.7% for kanamycin to 98.1% for isoniazid; specificity was 99.6% for kanamycin and 100% for the other antibiotics. However, assay performance against phenotypic resistance characterisation was less accurate …
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.
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