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Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection.
Georghiou, Sophia B; Alagna, Riccardo; Cirillo, Daniela M; Carmona, Sergio; Ruhwald, Morten; Schumacher, Samuel G.
Affiliation
  • Georghiou SB; FIND, The Global Alliance for Diagnostics, Geneva, Switzerland.
  • Alagna R; IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Cirillo DM; IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Carmona S; FIND, The Global Alliance for Diagnostics, Geneva, Switzerland.
  • Ruhwald M; FIND, The Global Alliance for Diagnostics, Geneva, Switzerland.
  • Schumacher SG; FIND, The Global Alliance for Diagnostics, Geneva, Switzerland.
PLoS One ; 16(12): e0261442, 2021.
Article in En | MEDLINE | ID: mdl-34919559
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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Full text: 1 Collection: 01-internacional Health context: 2_ODS3 / 3_ND Database: MEDLINE Main subject: Tuberculosis, Pulmonary / Tuberculosis, Multidrug-Resistant / Point-of-Care Testing / Antibiotics, Antitubercular / Mycobacterium tuberculosis Type of study: Diagnostic_studies Limits: Humans Language: En Journal: PLoS One Year: 2021 Document type: Article
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Full text: 1 Collection: 01-internacional Health context: 2_ODS3 / 3_ND Database: MEDLINE Main subject: Tuberculosis, Pulmonary / Tuberculosis, Multidrug-Resistant / Point-of-Care Testing / Antibiotics, Antitubercular / Mycobacterium tuberculosis Type of study: Diagnostic_studies Limits: Humans Language: En Journal: PLoS One Year: 2021 Document type: Article