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

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...

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Autores principales: Georghiou, Sophia B., Alagna, Riccardo, Cirillo, Daniela M., Carmona, Sergio, Ruhwald, Morten, Schumacher, Samuel G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8682871/
https://www.ncbi.nlm.nih.gov/pubmed/34919559
http://dx.doi.org/10.1371/journal.pone.0261442
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author Georghiou, Sophia B.
Alagna, Riccardo
Cirillo, Daniela M.
Carmona, Sergio
Ruhwald, Morten
Schumacher, Samuel G.
author_facet Georghiou, Sophia B.
Alagna, Riccardo
Cirillo, Daniela M.
Carmona, Sergio
Ruhwald, Morten
Schumacher, Samuel G.
author_sort Georghiou, Sophia B.
collection PubMed
description 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.
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spelling pubmed-86828712021-12-18 Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection Georghiou, Sophia B. Alagna, Riccardo Cirillo, Daniela M. Carmona, Sergio Ruhwald, Morten Schumacher, Samuel G. PLoS One Research Article 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. Public Library of Science 2021-12-17 /pmc/articles/PMC8682871/ /pubmed/34919559 http://dx.doi.org/10.1371/journal.pone.0261442 Text en © 2021 Georghiou et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Georghiou, Sophia B.
Alagna, Riccardo
Cirillo, Daniela M.
Carmona, Sergio
Ruhwald, Morten
Schumacher, Samuel G.
Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection
title Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection
title_full Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection
title_fullStr Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection
title_full_unstemmed Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection
title_short Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection
title_sort equivalence of the genexpert system and genexpert omni system for tuberculosis and rifampicin resistance detection
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8682871/
https://www.ncbi.nlm.nih.gov/pubmed/34919559
http://dx.doi.org/10.1371/journal.pone.0261442
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