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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Detalles Bibliográficos
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
Descripción
Sumario: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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