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

Diagn Microbiol Infect Dis. 2021 Sep;101(1):115397. doi: 10.1016/j.diagmicrobio.2021.115397. Epub 2021 Apr 20.

Abstract

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.

Keywords: Drug-resistant tuberculosis; drug susceptibility testing; molecular diagnostics.

Publication types

  • Validation Study

MeSH terms

  • Antibiotics, Antitubercular / pharmacology
  • Bacterial Proteins / genetics
  • Drug Resistance, Bacterial / drug effects
  • Drug Resistance, Bacterial / genetics*
  • Microbial Sensitivity Tests
  • Molecular Diagnostic Techniques*
  • Mutation
  • Mycobacterium tuberculosis / drug effects
  • Mycobacterium tuberculosis / genetics
  • Mycobacterium tuberculosis / isolation & purification
  • Sensitivity and Specificity
  • Tuberculosis / diagnosis
  • Tuberculosis, Multidrug-Resistant / diagnosis*

Substances

  • Antibiotics, Antitubercular
  • Bacterial Proteins