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dc.contributor.authorMadico, Guillermo
dc.contributor.authorMpeirwe, Moses
dc.contributor.authorWhite, Laura
dc.contributor.authorVinhas, Solange
dc.contributor.authorOrr, Beverley
dc.contributor.authorOrikiriza, Patrick
dc.contributor.authorMiller, Nancy S.
dc.contributor.authorGaeddert, Mary
dc.contributor.authorAmumpaire, Juliet Mwanga
dc.contributor.authorPalaci, Moises
dc.contributor.authorKreiswirth, Barry
dc.contributor.authorStraight, Joe
dc.contributor.authorDietze, Reynaldo
dc.contributor.authorII, Yap Boum,
dc.contributor.authorJones-López, Edward C.
dc.date.accessioned2022-08-26T08:17:07Z
dc.date.available2022-08-26T08:17:07Z
dc.date.issued2016
dc.identifier.citationMadico G, Mpeirwe M, White L, Vinhas S, Orr B, Orikiriza P, et al. (2016) Detection and Quantification of Mycobacterium tuberculosis in the Sputum of Culture-Negative HIV-infected Pulmonary Tuberculosis Suspects: A Proof-of-Concept Study. PLoS ONE 11(7): e0158371en_US
dc.identifier.urihttp://ir.must.ac.ug/xmlui/handle/123456789/2413
dc.description.abstractRationale: Rapid diagnosis of pulmonary tuberculosis (TB) is critical for timely initiation of treatment and interruption of transmission. Yet, despite recent advances, many patients remain undiagnosed. Culture, usually considered the most sensitive diagnostic method, is sub-optimal for paucibacillary disease. Methods: We evaluated the Totally Optimized PCR (TOP) TB assay, a new molecular test that we hypothesize is more sensitive than culture. After pre-clinical studies, we estimated TOP’s per-patient sensitivity and specificity in a convenience sample of 261 HIV-infected pulmonary TB suspects enrolled into a TB diagnostic study in Mbarara, Uganda against MGIT culture, Xpert MTB/RIF and a composite reference standard. We validated results with a confirmatory PCR used for sequencing M. tuberculosis. Measurements and Results: Using culture as reference, TOP had 100% sensitivity but 35% specificity. Against a composite reference standard, the sensitivity of culture (27%) and Xpert MTB/RIF (27lower than TOP (99%), with similar specificity (100%, 98% and 87%, respectively). In unadjusted analyses, culture-negative/TOP-positive patients were more likely to be older (P<0.001) female p<0.001), have salivary patum (p=0.05), sputum smear-negative (p<0.001) and less advanced disease on chest radiograph p=0.005). M. tuberculosis genotypes identified in sputum by DNA sequencing exhibit differential growth in culture. Conclusion: These findings suggest that the TOP TB assay is accurately detecting M. tuberculosis DNA in the sputum of culture-negative tuberculosis suspects. Our results require prospective validation with clinical outcomes. If the operating characteristics of the TOP assay are confirmed in future studies, it will be justified as a “TB rule out” test.en_US
dc.description.sponsorshipInternal funds, The Uganda Research Student Support Fund (URSSF), and in part by Thisis Diagnostics, Incen_US
dc.language.isoen_USen_US
dc.publisherPLoS ONEen_US
dc.subjectTuberculosisen_US
dc.subjectTreatmenten_US
dc.subjectInterruption of transmissionen_US
dc.subjectHIVen_US
dc.titleDetection and Quantification of Mycobacterium tuberculosis in the Sputum of Culture-Negative HIV-infected Pulmonary Tuberculosis Suspects: A Proof-of-Concept Studyen_US
dc.typeArticleen_US


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