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Public Library of Science, PLoS ONE, 12(16), p. e0261442, 2021

DOI: 10.1371/journal.pone.0261442

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

Journal article published in 2021 by Sophia B. Georghiou ORCID, Riccardo Alagna, Daniela M. Cirillo, Sergio Carmona, Morten Ruhwald ORCID, Samuel G. Schumacher ORCID
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

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.