Evaluation of the Xpert MTB/RIF Assay for the Diagnosis of Pulmonary Tuberculosis in a High HIV Prevalence Setting
作者： Grant Theron , Jonny Peter , Richard van Zyl-Smit , Hridesh Mishra , Elizabeth Streicher
DOI: 10.1164/RCCM.201101-0056OC
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摘要: Rationale: Xpert MTB/RIF is a novel automated molecular diagnostic recently endorsed by the World Health Organization. However, performance-related data from high HIV prevalence settings are limited.Objectives: The impact of sample-related factors on performance and significance MTB/RIF-positive culture-negative discordance remain unclear.Methods: was evaluated using single archived spot-sputum samples 496 South African patients with suspected TB. Mycobacterium tuberculosis culture positivity phenotypic resistance to rifampicin served as reference standards.Measurements Main Results: Overall, detected 95% (95% confidence interval [CI], 88–98%; 89 94) smear-positive culture-positive cases specificity 94% (91–96%; 320 339). sensitivity in smear-negative 55% (35–73%; 12 22) when analysis restricted 1 ml unprocessed sputum time-to-positivity less than or equal 28 days. Compared smea...
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