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.
Highlights
Despite the gains made in tuberculosis (TB) and drug-resistant TB (DR-TB) diagnosis since the launch and rollout of rapid molecular assays, including the Cepheid Xpert and Molbio TrueNat assays [1], diagnostic gaps remain
The aim of this study was to evaluate the equivalence of Omni compared to GeneXpert through MTB Ultra testing of well-characterized clinical specimens and controls
The results confirmed high concordance between the Omni and GeneXpert devices in clinical specimens tested at normal environmental conditions as well as for an MMQCI control panel tested at high temperature and humidity conditions, including equivalent Cts for all MTB Ultra probes
Summary
Despite the gains made in tuberculosis (TB) and drug-resistant TB (DR-TB) diagnosis since the launch and rollout of rapid molecular assays, including the Cepheid Xpert and Molbio TrueNat assays [1], diagnostic gaps remain. The use of rapid molecular assays in peripheral settings is limited by insufficient infrastructure (i.e. stable power supply) and challenging environmental conditions [4]. To address this issue, Cepheid has developed the GeneXpert Omni System (‘Omni’) for Xpert cartridge testing in remote, low-throughput settings with limited infrastructure.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
