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Multicenter Study of the Accuracy of the BD MAX MDR-TB Assay for Detection of Mycobacterium tuberculosis Complex and Mutations Associated with Resistance to Rifampin and Isoniazid.

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dc.contributor.author Shah, Maunank
dc.contributor.author Paradis, Sonia
dc.contributor.author Betz, Joshua
dc.contributor.author Beylis, Natalie
dc.contributor.author Bharadwaj, Renu
dc.contributor.author Caceres, Tatiana
dc.contributor.author Gotuzzo, Eduardo
dc.contributor.author Joloba, Moses
dc.contributor.author Mave, Vidya
dc.contributor.author Nakiyingi, Lydia
dc.contributor.author Nicol, Mark P.
dc.contributor.author Pradhan, Neeta
dc.contributor.author King, Bonnie
dc.contributor.author Armstrong, Derek
dc.contributor.author Knecht, Deborah
dc.contributor.author Maus, Courtney E.
dc.contributor.author Cooper, Charles K.
dc.contributor.author Dorman, Susan E.
dc.contributor.author Manabe, Yukari C.
dc.date.accessioned 2019-12-06T20:57:45Z
dc.date.available 2019-12-06T20:57:45Z
dc.date.issued 2019
dc.identifier.uri https://hdl.handle.net/20.500.12866/7394
dc.description.abstract BACKGROUND: Tuberculosis (TB) control is hindered by absence of rapid tests to identify Mycobacterium tuberculosis (MTB), and detect isoniazid (INH) and rifampin (RIF) resistance. We evaluated the accuracy of the BD MAX MDR-TB assay (BD MAX) in South Africa, Uganda, India, and Peru. METHODS: Outpatient adults with signs and/or symptoms of pulmonary TB were prospectively enrolled. Sputum smear-microscopy and BD MAX were performed on a single raw sputum, which was then processed for mycobacterial culture and phenotypic drug susceptibility testing (DST), BD MAX and Xpert MTB/RIF (Xpert). RESULTS: 1053 participants with presumptive TB were enrolled with median age of 35 (47% female; 32% HIV-infected, and 32% unknown HIV status). In microbiologically-confirmed TB patients, BD MAX sensitivity was 93% (262/282 [95% CI 89, 95]); specificity was 97% (593/610 [96, 98]) among participants with negative cultures on raw sputa. BD MAX sensitivity was 100% (175/175, [98,100]) for smear-positive samples (florescence smear-microscopy), and 81% (87/107, [73,88]) in smear-negative samples. Among participants with both BD MAX and Xpert, sensitivity was 91% (249/274, [87,94]) for BD MAX and 90% (246/274 [86,93]) for Xpert on processed sputa. Sensitivity and specificity for RIF resistance compared to phenotypic DST was 90% (9/10 [60,98]) and 95% (211/222 [91,97]), respectively. Sensitivity and specificity for detection of INH resistance was 82% (22/27 [63,92]) and 100% (205/205 [98,100]), respectively. CONCLUSIONS: The BD MAX MDR-TB assay had high sensitivity and specificity for detection of MTB, and RIF and INH drug resistance and may be an important tool for rapid detection of TB and MDR-TB globally. en_US
dc.language.iso eng
dc.publisher Oxford University Press
dc.relation.ispartof urn:issn:1537-6591
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject acquired immunodeficiency syndrome en_US
dc.subject diagnosis en_US
dc.subject HIV en_US
dc.subject multidrug resistance en_US
dc.subject mycobacterium infections en_US
dc.subject tuberculosis en_US
dc.title Multicenter Study of the Accuracy of the BD MAX MDR-TB Assay for Detection of Mycobacterium tuberculosis Complex and Mutations Associated with Resistance to Rifampin and Isoniazid. en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1093/cid/ciz932
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.03.08


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