Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection
- Resource Type
- Authors
- Sophia B. Georghiou; Riccardo Alagna; Daniela M. Cirillo; Sergio Carmona; Morten Ruhwald; Samuel G. Schumacher
- Source
- PLoS ONE
PLoS ONE, Vol 16, Iss 12, p e0261442 (2021)
- Subject
- Bacterial Diseases
Atmospheric Science
Physiology
Science
Extensively Drug-Resistant Tuberculosis
Gene Identification and Analysis
Bioengineering
Microbial Sensitivity Tests
Medical Conditions
Meteorology
Bacterial Proteins
Diagnostic Medicine
Drug Resistance, Multiple, Bacterial
Tuberculosis, Multidrug-Resistant
Medicine and Health Sciences
Genetics
Tuberculosis
Humans
Mutation Detection
Antibiotics, Antitubercular
Tuberculosis, Pulmonary
Multidisciplinary
Bacteria
Organisms
Sputum
Biology and Life Sciences
Humidity
DNA-Directed RNA Polymerases
Mycobacterium tuberculosis
Tropical Diseases
Body Fluids
Actinobacteria
Mucus
Infectious Diseases
Point-of-Care Testing
Earth Sciences
Medicine
Engineering and Technology
Tuberculosis Diagnosis and Management
Medical Devices and Equipment
Anatomy
Rifampin
Research Article
Biotechnology
- Language
- English
- ISSN
- 1932-6203
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.