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•The Xpert MTB/XDR assay has a limit of detection for M. tuberculosis equivalent to Xpert MTB/RIF.•The Xpert MTB/XDR assay reliably detects a wide range of globally relevant isoniazid-, ethionamide-, fluoroquinolone- and second-line injectable resistance mutations.•The Xpert MTB/XDR assay demonstrates potential for heteroresistance detection.
In a manufacturer-independent laboratory validation study, the Xpert MTB/XDR® assay demonstrated equivalent limit of detection to Xpert MTB/RIF®, detected 100% of tested resistance mutations and showed some utility for resistance detection in strain mixtures. The Xpert MTB/XDR assay is a reliable, sensitive assay for tuberculosis and expanded resistance detection.