Analytical performance of the Xpert MTB/XDR® assay for tuberculosis and expanded resistance detection.

Sophia B Georghiou,Adam Penn-Nicholson,Margaretha de Vos,Aurélien Macé,Melanie W Syrmis, Kevin Jacob, Alyanna Mape,Heta Parmar,Yuan Cao,Chris Coulter,Morten Ruhwald,Sushil K Pandey,Samuel G Schumacher,Claudia M Denkinger

Diagnostic microbiology and infectious disease（2021）

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摘要

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.

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