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.
Publication types
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Research Support, Non-U.S. Gov't
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Validation Study
MeSH terms
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Antibiotics, Antitubercular / pharmacology*
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Bacterial Proteins / genetics
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DNA-Directed RNA Polymerases / genetics
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Drug Resistance, Multiple, Bacterial / genetics
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Humans
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Microbial Sensitivity Tests
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Mycobacterium tuberculosis / drug effects*
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Mycobacterium tuberculosis / genetics
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Mycobacterium tuberculosis / isolation & purification
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Point-of-Care Testing*
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Rifampin / pharmacology
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Sputum / microbiology
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Tuberculosis, Multidrug-Resistant / diagnosis*
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Tuberculosis, Multidrug-Resistant / drug therapy
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Tuberculosis, Pulmonary / diagnosis*
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Tuberculosis, Pulmonary / drug therapy
Substances
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Antibiotics, Antitubercular
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Bacterial Proteins
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rpoB protein, Mycobacterium tuberculosis
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DNA-Directed RNA Polymerases
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Rifampin
Grants and funding
This work was supported by a grant to FIND (MR, SBG, SC, SGS) from the German Federal Ministry of Education and Research (BMBF) through KfW (
https://www.bmbf.de/bmbf/en/home/home_node.html). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.