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dc.contributor.authorDharan, Nila J.
dc.contributor.authorBlakemore, Robert
dc.contributor.authorSloutsky, Alexander
dc.contributor.authorKaur, Devinder
dc.contributor.authorAlexander, Richard C.
dc.contributor.authorGhajar, Minoo
dc.contributor.authorMusser, Kimberlee A.
dc.contributor.authorEscuyer, Vincent E.
dc.contributor.authorRowlinson, Marie-Claire
dc.contributor.authorCrowe, Susanne
dc.contributor.authorLaniado-Laborin, Rafael
dc.contributor.authorValli, Eloise
dc.contributor.authorNabeta, Pamela
dc.contributor.authorJohnson, Pamela
dc.contributor.authorAlland, David
dc.date2022-08-11T08:09:46.000
dc.date.accessioned2022-08-23T16:43:06Z
dc.date.available2022-08-23T16:43:06Z
dc.date.issued2016-12-20
dc.date.submitted2017-05-16
dc.identifier.citationBMC Infect Dis. 2016 Dec 20;16(1):764. <a href="https://doi.org/10.1186/s12879-016-2039-4">Link to article on publisher's site</a>
dc.identifier.issn1471-2334 (Linking)
dc.identifier.doi10.1186/s12879-016-2039-4
dc.identifier.pmid27993132
dc.identifier.urihttp://hdl.handle.net/20.500.14038/40223
dc.description.abstractBACKGROUND: The Xpert(R) MTB/RIF (Xpert) assay is a rapid PCR-based assay for the detection of Mycobacterium tuberculosis complex DNA (MTBc) and mutations associated with rifampin resistance (RIF). An updated version introduced in 2011, the G4 Xpert, included modifications to probe B and updated analytic software. METHODS: An analytical study was performed to assess Xpert detection of mutations associated with rifampin resistance in rifampin-susceptible and -resistant isolates. A clinical study was performed in which specimens from US and non-US persons suspected of tuberculosis (TB) were tested to determine Xpert performance characteristics. All specimens underwent smear microscopy, mycobacterial culture, conventional drug-susceptibility testing and Xpert testing; DNA from isolates with discordant rifampin resistance results was sequenced. RESULTS: Among 191 laboratory-prepared isolates in the analytical study, Xpert sensitivity for detection of rifampin resistance associated mutations was 97.7% and specificity was 90.8%, which increased to 99.0% after DNA sequencing analysis of the discordant samples. Of the 1,096 subjects in the four clinical studies, 49% were from the US. Overall, Xpert detected MTBc in 439 of 468 culture-positive specimens for a sensitivity of 93.8% (95% confidence interval [CI]: 91.2%-95.7%) and did not detect MTBc in 620 of 628 culture-negative specimens for a specificity of 98.7% (95% CI: 97.5%-99.4%). Sensitivity was 99.7% among smear-positive cases, and 76.1% among smear-negative cases. Non-determinate MTBc detection and false-positive RIF resistance results were low (1.2 and 0.9%, respectively). CONCLUSIONS: The updated Xpert assay retained the high sensitivity and specificity of the previous assay versions and demonstrated low rates of non-determinate and RIF resistance false positive results.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=27993132&dopt=Abstract">Link to Article in PubMed</a>
dc.rights© The Author(s). 2016.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectDiagnostics
dc.subjectG4
dc.subjectGeneXpert
dc.subjectTuberculosis
dc.subjectXpert
dc.subjectBacterial Infections and Mycoses
dc.subjectImmunology and Infectious Disease
dc.subjectInfectious Disease
dc.subjectMicrobiology
dc.titlePerformance of the G4 Xpert(R) MTB/RIF assay for the detection of Mycobacterium tuberculosis and rifampin resistance: a retrospective case-control study of analytical and clinical samples from high- and low-tuberculosis prevalence settings
dc.typeJournal Article
dc.source.journaltitleBMC infectious diseases
dc.source.volume16
dc.source.issue1
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=4022&amp;context=oapubs&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/oapubs/3017
dc.identifier.contextkey10171423
refterms.dateFOA2022-08-23T16:43:06Z
html.description.abstract<p>BACKGROUND: The Xpert(R) MTB/RIF (Xpert) assay is a rapid PCR-based assay for the detection of Mycobacterium tuberculosis complex DNA (MTBc) and mutations associated with rifampin resistance (RIF). An updated version introduced in 2011, the G4 Xpert, included modifications to probe B and updated analytic software.</p> <p>METHODS: An analytical study was performed to assess Xpert detection of mutations associated with rifampin resistance in rifampin-susceptible and -resistant isolates. A clinical study was performed in which specimens from US and non-US persons suspected of tuberculosis (TB) were tested to determine Xpert performance characteristics. All specimens underwent smear microscopy, mycobacterial culture, conventional drug-susceptibility testing and Xpert testing; DNA from isolates with discordant rifampin resistance results was sequenced.</p> <p>RESULTS: Among 191 laboratory-prepared isolates in the analytical study, Xpert sensitivity for detection of rifampin resistance associated mutations was 97.7% and specificity was 90.8%, which increased to 99.0% after DNA sequencing analysis of the discordant samples. Of the 1,096 subjects in the four clinical studies, 49% were from the US. Overall, Xpert detected MTBc in 439 of 468 culture-positive specimens for a sensitivity of 93.8% (95% confidence interval [CI]: 91.2%-95.7%) and did not detect MTBc in 620 of 628 culture-negative specimens for a specificity of 98.7% (95% CI: 97.5%-99.4%). Sensitivity was 99.7% among smear-positive cases, and 76.1% among smear-negative cases. Non-determinate MTBc detection and false-positive RIF resistance results were low (1.2 and 0.9%, respectively).</p> <p>CONCLUSIONS: The updated Xpert assay retained the high sensitivity and specificity of the previous assay versions and demonstrated low rates of non-determinate and RIF resistance false positive results.</p>
dc.identifier.submissionpathoapubs/3017
dc.contributor.departmentDepartment of Medicine, Division of Infectious Diseases and Immunology
dc.source.pages764


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