{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T11:22:53Z","timestamp":1789384973181,"version":"build-2803163510"},"reference-count":14,"publisher":"American Society for Microbiology","issue":"4","license":[{"start":{"date-parts":[[2016,4,1]],"date-time":"2016-04-01T00:00:00Z","timestamp":1459468800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100000002","name":"The National Institutes of Health","doi-asserted-by":"crossref","award":["HHSN2722000900050C"],"award-info":[{"award-number":["HHSN2722000900050C"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000002","name":"The National Institutes of Health","doi-asserted-by":"crossref","award":["K24AI104830"],"award-info":[{"award-number":["K24AI104830"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"crossref"}]},{"name":"The Foundation for Innovative New Diagnostics"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2016,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            The Epistem Genedrive assay rapidly detects the\n            <jats:named-content content-type=\"genus-species\">Mycobacterium tuberculosis<\/jats:named-content>\n            complex from sputum and is currently available for clinical use. However, the analytical and clinical performance of this test has not been fully evaluated. The analytical limit of detection (LOD) of the Genedrive PCR amplification was tested with genomic DNA; the performance of the complete (sample processing plus amplification) system was tested by spiking\n            <jats:named-content content-type=\"genus-species\">M. tuberculosis<\/jats:named-content>\n            mc\n            <jats:sup>2<\/jats:sup>\n            6030 cells into distilled water and\n            <jats:named-content content-type=\"genus-species\">M. tuberculosis<\/jats:named-content>\n            -negative sputum. Specificity was tested using common respiratory pathogens and nontuberculosis mycobacteria. A clinical evaluation enrolled adults with suspected pulmonary tuberculosis, obtained three sputum samples from each participant, and compared the accuracy of the Genedrive to that of the Xpert MTB\/RIF assay using\n            <jats:named-content content-type=\"genus-species\">M. tuberculosis<\/jats:named-content>\n            cultures as the reference standard. The Genedrive assay had an LOD of 1 pg\/\u03bcl (100 genomic DNA copies\/reaction). The LODs of the system were 2.5 \u00d7 10\n            <jats:sup>4<\/jats:sup>\n            CFU\/ml and 2.5 \u00d7 10\n            <jats:sup>5<\/jats:sup>\n            CFU\/ml for cells spiked into water and sputum, respectively. False-positive\n            <jats:italic>rpoB<\/jats:italic>\n            probe signals were observed in 3\/32 (9.4%) of the negative controls and also in few samples containing\n            <jats:named-content content-type=\"genus-species\">Mycobacterium abscessus<\/jats:named-content>\n            ,\n            <jats:named-content content-type=\"genus-species\">Mycobacterium gordonae<\/jats:named-content>\n            , or\n            <jats:named-content content-type=\"genus-species\">Mycobacterium thermoresistibile<\/jats:named-content>\n            . In the clinical study, among 336 analyzed participants, the overall sensitivities for the tuberculosis case detection of Genedrive, Xpert, and smear microscopy were 45.4% (95% confidence interval [CI], 35.2% to 55.8%), 91.8% (95% CI, 84.4% to 96.4%), and 77.3% (95% CI, 67.7% to 85.2%), respectively. The sensitivities of Genedrive and Xpert for the detection of smear-microscopy-negative tuberculosis were 0% (95% CI, 0% to 15.4%) and 68.2% (95% CI, 45.1% to 86.1%), respectively. The Genedrive assay did not meet performance standards recommended by the World Health Organization for a smear microscopy replacement tuberculosis test. Epistem is working on modifications to improve the assay.\n          <\/jats:p>","DOI":"10.1128\/jcm.02847-15","type":"journal-article","created":{"date-parts":[[2016,2,11]],"date-time":"2016-02-11T20:33:22Z","timestamp":1455222802000},"page":"1051-1057","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":18,"title":["Analytical and Clinical Evaluation of the Epistem Genedrive Assay for Detection of Mycobacterium tuberculosis"],"prefix":"10.1128","volume":"54","author":[{"given":"Shubhada","family":"Shenai","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Center for Emerging Pathogens, Rutgers\u2014New Jersey Medical School, Rutgers Biomedical &amp; Health Sciences, Newark, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derek T.","family":"Armstrong","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eloise","family":"Valli","sequence":"additional","affiliation":[{"name":"Foundation for Innovative New Diagnostics, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L.","family":"Dolinger","sequence":"additional","affiliation":[{"name":"Foundation for Innovative New Diagnostics, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lydia","family":"Nakiyingi","sequence":"additional","affiliation":[{"name":"Infectious Disease Institute and Makerere University, Kampala, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reynaldo","family":"Dietze","sequence":"additional","affiliation":[{"name":"Universidade Federal do Espirito Santo, Vitoria, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margareth Pretti","family":"Dalcolmo","sequence":"additional","affiliation":[{"name":"Centro de Refer\u00eancia Helio Fraga, FIOCRUZ, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark P.","family":"Nicol","sequence":"additional","affiliation":[{"name":"University of Cape Town and National Health Laboratory Service, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Widaad","family":"Zemanay","sequence":"additional","affiliation":[{"name":"University of Cape Town and National Health Laboratory Service, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuka","family":"Manabe","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"},{"name":"Infectious Disease Institute and Makerere University, Kampala, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David Jamil","family":"Hadad","sequence":"additional","affiliation":[{"name":"Universidade Federal do Espirito Santo, Vitoria, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Marques-Rodrigues","sequence":"additional","affiliation":[{"name":"Universidade Federal do Espirito Santo, Vitoria, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moises","family":"Palaci","sequence":"additional","affiliation":[{"name":"Universidade Federal do Espirito Santo, Vitoria, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renata L.","family":"Peres","sequence":"additional","affiliation":[{"name":"Universidade Federal do Espirito Santo, Vitoria, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Gaeddert","sequence":"additional","affiliation":[{"name":"Boston Medical Center, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Armakovitch","sequence":"additional","affiliation":[{"name":"Boston Medical Center, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bareng A. S.","family":"Nonyane","sequence":"additional","affiliation":[{"name":"Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia M.","family":"Denkinger","sequence":"additional","affiliation":[{"name":"Foundation for Innovative New Diagnostics, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Padmapriya","family":"Banada","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Center for Emerging Pathogens, Rutgers\u2014New Jersey Medical School, Rutgers Biomedical &amp; Health Sciences, Newark, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moses L.","family":"Joloba","sequence":"additional","affiliation":[{"name":"Makerere University Mycobacteriology Laboratory, Kampala, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerrold","family":"Ellner","sequence":"additional","affiliation":[{"name":"Boston Medical Center, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catharina","family":"Boehme","sequence":"additional","affiliation":[{"name":"Foundation for Innovative New Diagnostics, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Alland","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Center for Emerging Pathogens, Rutgers\u2014New Jersey Medical School, Rutgers Biomedical &amp; Health Sciences, Newark, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan E.","family":"Dorman","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.4.2.94"},{"key":"e_1_3_3_3_2","first-page":"415","article-title":"Tuberculosis","volume":"100","author":"Harries AD","year":"2006","unstructured":"Harries AD, Dye C. 2006. 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High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. In Proceedings of the WHO\/HTM\/TB\/2014.18. WHO, Geneva, Switzerland."}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.02847-15","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.02847-15","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,5]],"date-time":"2022-03-05T09:51:32Z","timestamp":1646473892000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/JCM.02847-15"}},"subtitle":[],"editor":[{"given":"G. 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