{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T04:42:56Z","timestamp":1794026576258,"version":"4.8.0"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2019,9,27]],"date-time":"2019-09-27T00:00:00Z","timestamp":1569542400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Becton, Dickinson and Company"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,8,22]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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 multidrug-resistant (MDR)-TB assay (BD MAX) in South Africa, Uganda, India, and Peru.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Outpatient adults with signs\/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 culture and phenotypic drug susceptibility testing (DST), BD MAX, and Xpert MTB\/RIF (Xpert).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>1053 participants with presumptive TB were enrolled (47% female; 32% with human immunodeficiency virus). In patients with confirmed TB, BD MAX sensitivity was 93% (262\/282 [95% CI, 89\u201395%]); specificity was 97% (593\/610 [96\u201398%]) among participants with negative cultures on raw sputa. BD MAX sensitivity was 100% (175\/175 [98\u2013100%]) for smear-positive samples (fluorescence microscopy), and 81% (87\/107 [73\u201388%]) in smear-negative samples. Among participants with both BD MAX and Xpert, sensitivity was 91% (249\/274 [87\u201394%]) for BD MAX and 90% (246\/274 [86\u201393%]) for Xpert on processed sputa. Sensitivity and specificity for RIF resistance compared with phenotypic DST were 90% (9\/10 [60\u201398%]) and 95% (211\/222 [91\u201397%]), respectively. Sensitivity and specificity for detection of INH resistance were 82% (22\/27 [63\u201392%]) and 100% (205\/205 [98\u2013100%]), respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciz932","type":"journal-article","created":{"date-parts":[[2019,9,24]],"date-time":"2019-09-24T12:18:02Z","timestamp":1569327482000},"page":"1161-1167","source":"Crossref","is-referenced-by-count":55,"title":["Multicenter Study of the Accuracy of the BD MAX Multidrug-resistant Tuberculosis Assay for Detection of Mycobacterium tuberculosis Complex and Mutations Associated With Resistance to Rifampin and Isoniazid"],"prefix":"10.1093","volume":"71","author":[{"given":"Maunank","family":"Shah","sequence":"first","affiliation":[{"name":"Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Paradis","sequence":"additional","affiliation":[{"name":"Becton, Dickinson and Company, Sparks, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua","family":"Betz","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"},{"name":"Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalie","family":"Beylis","sequence":"additional","affiliation":[{"name":"Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa"},{"name":"Medical Microbiology Laboratory National Health Laboratory Services Groote Schuur Hospital, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renu","family":"Bharadwaj","sequence":"additional","affiliation":[{"name":"Byramjee Jeejeebhoy Government Medical College, Johns Hopkins University Clinical Research Site, Pune, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana","family":"Caceres","sequence":"additional","affiliation":[{"name":"Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo","family":"Gotuzzo","sequence":"additional","affiliation":[{"name":"Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moses","family":"Joloba","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vidya","family":"Mave","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"},{"name":"Byramjee Jeejeebhoy Government Medical College, Johns Hopkins University Clinical Research Site, Pune, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lydia","family":"Nakiyingi","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark P","family":"Nicol","sequence":"additional","affiliation":[{"name":"Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa"},{"name":"Division of Infection and Immunity, School of Biomedical Sciences, University of Western Australia, Perth, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neeta","family":"Pradhan","sequence":"additional","affiliation":[{"name":"Byramjee Jeejeebhoy Government Medical College, Johns Hopkins University Clinical Research Site, Pune, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie","family":"King","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derek","family":"Armstrong","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Knecht","sequence":"additional","affiliation":[{"name":"Becton, Dickinson and Company, Sparks, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Courtney 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Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,9,27]]},"reference":[{"key":"2020082200570245300_CIT0001","author":"World Health Organization"},{"key":"2020082200570245300_CIT0002","first-page":"1163","article-title":"A comprehensive comparison of Ziehl-Neelsen and fluorescence microscopy for the diagnosis of tuberculosis in a resource-poor urban setting","volume":"7","author":"Kivihya-Ndugga","year":"2003","journal-title":"Int J Tuberc Lung Dis"},{"key":"2020082200570245300_CIT0003","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1128\/JCM.01463-09","article-title":"Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology","volume":"48","author":"Helb","year":"2010","journal-title":"J Clin Microbiol"},{"key":"2020082200570245300_CIT0004","doi-asserted-by":"crossref","first-page":"1005","DOI":"10.1056\/NEJMoa0907847","article-title":"Rapid molecular 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