PLoS ONE (Jan 2021)

Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection.

  • Sophia B Georghiou,
  • Riccardo Alagna,
  • Daniela M Cirillo,
  • Sergio Carmona,
  • Morten Ruhwald,
  • Samuel G Schumacher

DOI
https://doi.org/10.1371/journal.pone.0261442
Journal volume & issue
Vol. 16, no. 12
p. e0261442

Abstract

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A laboratory validation study was conducted to assess the equivalence of Xpert MTB/RIF Ultra testing on the GeneXpert System and the GeneXpert Omni System ('Omni') for tuberculosis and rifampicin resistance. High concordance of the two devices was demonstrated for well-characterized clinical samples as well as control materials, with controls tested on Omni at normal and challenging environmental conditions (i.e. 35°C, 90% relative humidity). Equivalence of the Cts for all probes was also shown. Equivalence was demonstrated for the Omni and GeneXpert devices for tuberculosis and rifampicin resistance detection for a diverse range of clinical specimens and environmental conditions.