FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the development, evaluation and introduction of an Xpert MTB/XDR assay
Study Type
OBSERVATIONAL
Enrollment
710
The Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA) is an integrated, automated, cartridge-based system for MDR-TB diagnosis that uses the GeneXpert instrument platform. WHO confirmed evidence to support the widespread use of the Xpert MTB/RIF assay in 2010 and the assay has since been widely used in TB programs, but it is only capable of identifying Mycobacterium tuberculosis (Mtb) and detecting RIF resistance. The Xpert MTB/XDR assay will be evaluated for INH and second-line resistance detection, and to recommend its use in diverse clinical settings. The focus of this protocol is the multicentre clinical evaluation.
Institute of Pthisiopenumology
Chisinau, Moldova
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection
Sensitivity and specificity estimates for INH and ETH resistance detection
Time frame: Day 1
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection
Sensitivity and specificity estimates for fluoroquinolone resistance detection
Time frame: Day 1
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection
Sensitivity and specificity estimates for second-line injectable resistance detection
Time frame: Day 1
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