{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T01:24:54Z","timestamp":1789694694972,"version":"4.0.1"},"reference-count":13,"publisher":"AOSIS","issue":"1","license":[{"start":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T00:00:00Z","timestamp":1767830400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:p>Background:\u00a0Drug-resistant tuberculosis (DR-TB) continues to be a major public health threat, especially in high-burden settings like South Africa. Rapid and accurate diagnosis of resistance to rifampicin (RIF) and isoniazid (INH) is essential to ensure that patients receive the right treatment as early as possible. Current diagnostic tools, though effective, have limitations. This study addresses the urgent need for faster, reliable alternatives to improve DR-TB detection.\nAim:\u00a0The aim of this study is to assess the performance of the FluoroType MTBDR assay in detecting resistance to RIF and INH in a real-world diagnostic setting.\nSetting:\u00a0The study was carried out at the National Health Laboratory Services (NHLS) Polokwane Laboratory, a routine laboratory in Limpopo province, South Africa.\nMethods:\u00a0We tested 152\u00a0Mycobacterium tuberculosis\u00a0(MTB) isolates collected from the 2023 laboratory repository using the FluoroType MTBDR version 2 assay. These results were compared with those from two established methods: GenoType MTBDRplus and Xpert MTB\/RIF Ultra. Whole genome sequencing (WGS) was used to resolve any discrepancies, serving as the reference standard. Diagnostic accuracy was evaluated using sensitivity, specificity and predictive values.\nResults:\u00a0Of the 152 isolates, 65% were drug-resistant. FluoroType MTBDR showed excellent performance \u2013 100% specificity and 96% sensitivity for RIF resistance and 91% sensitivity and 99% specificity for INH resistance \u2013 competing with the GenoType MTBDRplus.\nConclusion:\u00a0FluoroType MTBDR offers a reliable, rapid alternative for detecting DR-TB, with the potential to improve timely diagnosis and treatment.\nContribution:\u00a0This study highlights the FluoroType MTBDR assay as a valuable diagnostic tool for routine use, contributing to improved TB control strategies, especially in resource-limited, high-burden settings, consistent with the journal\u2019s scope.<\/jats:p>","DOI":"10.4102\/phcfm.v18i1.5034","type":"journal-article","created":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T07:58:38Z","timestamp":1767772718000},"update-policy":"https:\/\/doi.org\/10.4102\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Diagnostic performance of the FluoroType MTBDR assay for rifampicin and isoniazid resistance in routine laboratory setting"],"prefix":"10.4102","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6279-6409","authenticated-orcid":false,"given":"Ivy","family":"Rukasha","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/017p87168","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Limpopo"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5351-7834","authenticated-orcid":false,"given":"Kabelo G.","family":"Kaapu","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/017p87168","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Limpopo"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8560-8581","authenticated-orcid":false,"given":"Molebogeng R.","family":"Lekalakala-Mokaba","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/017p87168","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Limpopo"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2580","published-online":{"date-parts":[[2026,1,8]]},"reference":[{"key":"ref0","unstructured":"World Health Organization. Global tuberculosis report 2023 [homepage on the Internet]. 2023 [cited 2024 Feb 19]. Available from: https:\/\/www.who.int\/publications\/i\/item\/9789240083851"},{"key":"ref1","unstructured":"WHO. THE stop TB strategy building on and enhancing DOTS to meet the TB-related Millennium Development Goals [homepage on the Internet]. 2006 [cited 2023 Jan 29]. Available from: https:\/\/www.who.int\/publications-detail-redirect\/WHO-HTM-TB-2006.368"},{"key":"ref2","unstructured":"World Health Organization. Operational handbook on tuberculosis [Internet]. 2022. Available from: https:\/\/www.who.int\/publications\/i\/item\/9789240050761"},{"key":"ref3","unstructured":"WHO. Line probe assays for detection of drug-resistant tuberculosis: Interpretation and reporting manual for laboratory staff and clinicians [homepage on the Internet]. Geneva: World Health Organization; 2022 [cited 2023 Feb 19]. Available from: https:\/\/www.who.int\/publications\/i\/item\/9789240046665"},{"key":"ref4","doi-asserted-by":"crossref","unstructured":"Shah M, Paradis S, Betz J, et al. 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. Clin Infect Dis. 2019;71(5): 1161. https:\/\/doi.org\/10.1093\/cid\/ciz932","DOI":"10.1093\/cid\/ciz932"},{"key":"ref5","doi-asserted-by":"crossref","unstructured":"De Vos M, Derendinger B, Dolby T, et al. Diagnostic accuracy and utility of FluoroType MTBDR, a new molecular assay for multidrug-resistant tuberculosis. J Clin Microbiol. 2018;56(9):e00531-18. https:\/\/doi.org\/10.1128\/JCM.00531-18","DOI":"10.1128\/JCM.00531-18"},{"key":"ref6","doi-asserted-by":"crossref","unstructured":"Dippenaar A, Derendinger B, Dolby T, et al. Diagnostic accuracy of the FluoroType MTB and MTBDR VER 2.0 assays for the centralized high-throughput detection of Mycobacterium tuberculosis complex DNA and isoniazid and rifampicin resistance. Clin Microbiol Infect. 2021;27(9): 1351.e1\u20131351.e4. https:\/\/doi.org\/10.1016\/j.cmi.2021.04.022","DOI":"10.1016\/j.cmi.2021.04.022"},{"key":"ref7","doi-asserted-by":"crossref","unstructured":"Hillemann D, Haasis C, Andres S, et al. Validation of the FluoroType MTBDR assay for detection of rifampin and isoniazid resistance in Mycobacterium tuberculosis complex isolates. J Clin Microbiol. 2018;56(6):e00072-18. https:\/\/doi.org\/10.1128\/JCM.00072-18","DOI":"10.1128\/JCM.00072-18"},{"key":"ref8","doi-asserted-by":"crossref","unstructured":"Ismail N, Dippenaar A, Warren RM, et al. Emergence of canonical and noncanonical genomic variants following in vitro exposure of clinical Mycobacterium tuberculosis strains to Bedaquiline or Clofazimine. 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Whole genome sequencing Mycobacterium tuberculosis directly from sputum identifies more genetic diversity than sequencing from culture. BMC Genomics. 2019;20(1):389. https:\/\/doi.org\/10.1186\/s12864-019-5782-2","DOI":"10.1186\/s12864-019-5782-2"},{"key":"ref12","doi-asserted-by":"crossref","unstructured":"Yadav RN, Singh BK, Sharma R, et al. Comparative performance of line probe assay (Version 2) and Xpert MTB\/RIF assay for early diagnosis of rifampicin-resistant pulmonary tuberculosis. Tuberc Respir Dis (Seoul). 2021;84(3):237\u2013244. https:\/\/doi.org\/10.4046\/trd.2020.0171","DOI":"10.4046\/trd.2020.0171"}],"container-title":["African Journal of Primary Health Care &amp; Family Medicine"],"original-title":[],"link":[{"URL":"https:\/\/phcfm.org\/index.php\/phcfm\/article\/view\/5034\/8979","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T07:58:45Z","timestamp":1767772725000},"score":1,"resource":{"primary":{"URL":"https:\/\/phcfm.org\/index.php\/phcfm\/article\/view\/5034"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,8]]},"references-count":13,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,1,1]]}},"URL":"https:\/\/doi.org\/10.4102\/phcfm.v18i1.5034","relation":{},"ISSN":["2071-2928","2071-2936"],"issn-type":[{"value":"2071-2928","type":"print"},{"value":"2071-2936","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,8]]},"article-number":"a5034"}}