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:10.1371/journal.pone.0261442

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

PLoS One. 2021 Dec 17;16(12):e0261442. doi: 10.1371/journal.pone.0261442. eCollection 2021.

Authors

Sophia B Georghiou¹, Riccardo Alagna², Daniela M Cirillo², Sergio Carmona¹, Morten Ruhwald¹, Samuel G Schumacher¹

Affiliations

¹ FIND, The Global Alliance for Diagnostics, Geneva, Switzerland.
² IRCCS San Raffaele Scientific Institute, Milan, Italy.

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

Research Support, Non-U.S. Gov't
Validation Study

MeSH terms

Antibiotics, Antitubercular / pharmacology*
Bacterial Proteins / genetics
DNA-Directed RNA Polymerases / genetics
Drug Resistance, Multiple, Bacterial / genetics
Humans
Microbial Sensitivity Tests
Mycobacterium tuberculosis / drug effects*
Mycobacterium tuberculosis / genetics
Mycobacterium tuberculosis / isolation & purification
Point-of-Care Testing*
Rifampin / pharmacology
Sputum / microbiology
Tuberculosis, Multidrug-Resistant / diagnosis*
Tuberculosis, Multidrug-Resistant / drug therapy
Tuberculosis, Pulmonary / diagnosis*
Tuberculosis, Pulmonary / drug therapy

Substances

Antibiotics, Antitubercular
Bacterial Proteins
rpoB protein, Mycobacterium tuberculosis
DNA-Directed RNA Polymerases
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.