{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T09:11:21Z","timestamp":1791277881772,"version":"4.1.0"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2011,7,1]],"date-time":"2011-07-01T00:00:00Z","timestamp":1309478400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2011,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The impact of sample-related factors on performance and the significance of Xpert MTB\/RIF-positive culture-negative discordance remain unclear.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Xpert MTB\/RIF was evaluated using single archived spot-sputum samples from 496 South African patients with suspected TB. Mycobacterium tuberculosis culture positivity and phenotypic resistance to rifampicin served as reference standards.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measurements and Main Results<\/jats:title>\n                    <jats:p>Overall, Xpert MTB\/RIF detected 95% (95% confidence interval [CI], 88\u201398%; 89 of 94) of smear-positive culture-positive cases and the specificity was 94% (91\u201396%; 320 of 339). The sensitivity in smear-negative cases was 55% (35\u201373%; 12 of 22) when the analysis was restricted to 1 ml of unprocessed sputum and culture time-to-positivity of less than or equal to 28 days. Compared with smear microscopy (n = 94), Xpert MTB\/RIF detected an additional 17 cases (n = 111) representing an 18% (11\u201327%; 111 vs. 94) relative increase in the rapid TB case detection rate. Moreover, compared with smear microscopy, the inclusion of Xpert MTB\/RIF-positive culture-negative TB cases (ruled-in by an alternative diagnostic method) resulted in the detection of a further 16 cases (n = 127), thus significantly increasing the rapid TB case detection rate to 35% (95% CI, 26\u201345%; 94 to 111 vs. 94 to 127; P &amp;lt; 0.01), the overall specificity to 99.1% (97\u2013100%; 320 of 323; P &amp;lt; 0.001), and sensitivity in smear-negative TB to 60% (P = 0.12). Performance strongly correlated with smear status and culture time-to-positivity. In patients infected with HIV compared with patients uninfected with HIV Xpert MTB\/RIF showed a trend to reduced sensitivity (P = 0.09) and significantly reduced negative predictive value (P = 0.01). The negative predictive value for rifampicin resistance was 99.4%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>XpertMTB\/RIF outperformed smear microscopy, established a diagnosis in a significant proportion of patients with smear-negative TB, detected many highly likely TB cases missed by culture, and accurately ruled out rifampicin-resistant TB. Sample-specific factors had limited impact on performance. Performance in patients infected with HIV, especially those with advanced immunosuppression, warrants further study.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1164\/rccm.201101-0056oc","type":"journal-article","created":{"date-parts":[[2011,4,14]],"date-time":"2011-04-14T22:31:47Z","timestamp":1302820307000},"page":"132-140","source":"Crossref","is-referenced-by-count":254,"title":["Evaluation of the Xpert MTB\/RIF Assay for the Diagnosis of Pulmonary Tuberculosis in a High HIV Prevalence Setting"],"prefix":"10.1093","volume":"184","author":[{"given":"Grant","family":"Theron","sequence":"first","affiliation":[{"name":"Lung Infection and Immunity Unit, Division of Pulmonology and UCT Lung Institute, Department of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonny","family":"Peter","sequence":"additional","affiliation":[{"name":"Lung Infection and Immunity Unit, Division of Pulmonology and UCT Lung Institute, Department of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"van Zyl-Smit","sequence":"additional","affiliation":[{"name":"Lung Infection and Immunity Unit, Division of Pulmonology and UCT Lung Institute, Department of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hridesh","family":"Mishra","sequence":"additional","affiliation":[{"name":"Department of Medicine, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Streicher","sequence":"additional","affiliation":[{"name":"DST\/NRF Centre of Excellence for Biomedical TB Research\/MRC Centre for Molecular and Cellular Biology, Stellenbosch University, Stellenbosch, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"Murray","sequence":"additional","affiliation":[{"name":"Lung Infection and Immunity Unit, Division of Pulmonology and UCT Lung Institute, Department of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodney","family":"Dawson","sequence":"additional","affiliation":[{"name":"Lung Infection and Immunity Unit, Division of Pulmonology and UCT Lung Institute, Department of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Whitelaw","sequence":"additional","affiliation":[{"name":"Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Hoelscher","sequence":"additional","affiliation":[{"name":"Department for Infectious Diseases and Tropical Medicine, Klinikum of the University of Munich, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Surendra","family":"Sharma","sequence":"additional","affiliation":[{"name":"Department of Medicine, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madhukar","family":"Pai","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics, McGill University, Montreal, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin","family":"Warren","sequence":"additional","affiliation":[{"name":"DST\/NRF Centre of Excellence for Biomedical TB Research\/MRC Centre for Molecular and Cellular Biology, Stellenbosch University, Stellenbosch, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keertan","family":"Dheda","sequence":"additional","affiliation":[{"name":"Lung Infection and Immunity Unit, Division of Pulmonology and UCT Lung Institute, Department of Medicine"},{"name":"Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa"},{"name":"Department of Infection, University College London Medical School, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2011,7,1]]},"reference":[{"key":"2026032101181581300_bib1","article-title":"Global tuberculosis control. 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