Universidad Peruana Cayetano Heredia

A multisite assessment of the quantitative capabilities of the Xpert MTB/RIF assay

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dc.contributor.author Blakemore, R.
dc.contributor.author Nabeta, P.
dc.contributor.author Davidow, A.L.
dc.contributor.author Vadwai, V.
dc.contributor.author Tahirli, R.
dc.contributor.author Munsamy, V.
dc.contributor.author Nicol, M.
dc.contributor.author Jones, M.
dc.contributor.author Persing, D.H.
dc.contributor.author Hillemann, D.
dc.contributor.author Ruesch-Gerdes, S.
dc.contributor.author Leisegang, F.
dc.contributor.author Zamudio Fuertes, Carlos Eduardo
dc.contributor.author Rodrigues, C.
dc.contributor.author Boehme, C.C.
dc.contributor.author Perkins, M.D.
dc.contributor.author Alland, D.
dc.date.accessioned 2022-01-18T19:34:34Z
dc.date.available 2022-01-18T19:34:34Z
dc.date.issued 2011
dc.identifier.uri https://hdl.handle.net/20.500.12866/11020
dc.description.abstract Rationale: The Xpert MTB/RIF is an automated molecular test for Mycobacterium tuberculosis that estimates bacterial burden by measuring the threshold-cycle (Ct) of its M. tuberculosis-specific real-time polymerase chain reaction. Bacterialburden is an important biomarker for disease severity, infection control risk, and response to therapy. Objectives: Evaluate bacterial load quantitation by Xpert MTB/RIF compared with conventional quantitative methods. Methods: Xpert MTB/RIF results we recompared with smear-microscopy, semiquantiative solid culture, and time-to-detection in liquid culture for 741 patients and 2,008 samples tested in a multisite clinical trial. An internal control real-time polymerase chain reaction was evaluated for its ability to identify inaccurate quantitative Xpert MTB/RIF results. Measurements and Main Results: Assays with an internal control Ct greater than 34 were likely to be inaccurately quantitated; this represented 15% of M. tuberculosis-positive tests. Excluding these, decreasing M. tuberculosis Ct was associated with increasing smear microscopy grade for smears of concentrated sputum pellets (r s = 20.77) and directly from sputum (r s = -0.71). A Ct cutoff of approximately 27.7 best predicted smear-positive status. The association between M. tuberculosis Ct and time-to-detection in liquid culture (r s = 0.68) andsemiquantitative colony counts (r s = -0.56)wasweaker than smear. Tests of paired same-patient sputum showed that highviscosity sputum samples contained x32 more M. tuberculosis than nonviscous samples. Comparisons between the grade of the acid-fast bacilli smear and Xpert MTB/RIF quantitative data across study sites enabled us to identify a site outlier inmicroscopy. Conclusions: Xpert MTB/RIF quantitation offers a new, standardized approach to measuring bacterial burden in the sputum of patients with tuberculosis. en_US
dc.language.iso eng
dc.publisher American Thoracic Society
dc.relation.ispartofseries American Journal of Respiratory and Critical Care Medicine
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Humans en_US
dc.subject controlled study en_US
dc.subject major clinical study en_US
dc.subject diagnostic test en_US
dc.subject disease severity en_US
dc.subject quantitative analysis en_US
dc.subject Algorithms en_US
dc.subject bacterial load en_US
dc.subject Bacterial Proteins en_US
dc.subject Clinical trial en_US
dc.subject Diagnosis en_US
dc.subject Diagnostic techniques and procedures en_US
dc.subject DNA, Bacterial en_US
dc.subject infection control en_US
dc.subject Microscopy en_US
dc.subject Molecular diagnostics en_US
dc.subject Multicenter Studies as Topic en_US
dc.subject Mycobacterium tuberculosis en_US
dc.subject Nucleic Acid Amplification Techniques en_US
dc.subject Predictive Value of Tests en_US
dc.subject Randomized Controlled Trials as Topic en_US
dc.subject Real-Time Polymerase Chain Reaction en_US
dc.subject Research Design en_US
dc.subject Sensitivity and Specificity en_US
dc.subject Sputum en_US
dc.subject Tuberculosis en_US
dc.title A multisite assessment of the quantitative capabilities of the Xpert MTB/RIF assay en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1164/rccm.201103-0536OC
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.07
dc.relation.issn 1535-4970


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