{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T15:05:15Z","timestamp":1790867115596,"version":"4.1.0"},"reference-count":28,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,7]]},"abstract":"\n Background:<\/jats:title>\n Drug-resistant tuberculosis (DR-TB) poses a major global challenge to public health and therapeutics. It is an emerging global concern associated with increased morbidity and mortality mostly seen in the low- and middle-income countries. Molecular techniques are highly sensitive and offer timely and accurate results for TB drug resistance testing, thereby positively influencing patient management plan.<\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n \n The study was carried out at the National Tuberculosis Reference Laboratory (NTRL) in Kenya in the period between January and October 2022. A total of 243\n Mycobacterium tuberculosis<\/jats:italic>\n (M.tb) clinical isolates were included in the study. These isolates comprised of 50 isolates with mutations in\n rpoB<\/jats:italic>\n , 51 isolates with\n katG<\/jats:italic>\n mutations, 51 isolates with mutations in\n inhA<\/jats:italic>\n , and 91 M.tb isolates lacking mutations in these genes based on Genotype MTBDR\n plu<\/jats:italic>\n s results. DNA from the isolates was extracted using the FluoroLyse extraction kit. Real-time polymerase chain reaction targeting the\n rpoB<\/jats:italic>\n ,\n InhA,<\/jats:italic>\n and\n katG<\/jats:italic>\n genes was performed using the FluoroType MTBDR amplification mix. Isolates with discordant results between Genotype MTBDR\n plu<\/jats:italic>\n s and FluoroCycler\u00ae MTBDR assays underwent targeted sequencing for the respective genes, then, sequences were analyzed for mutations using Geneious version 11.0 software.\n <\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n \n The sensitivity of the Fluorocycler XT MTBDR assay for the detection of mutations that confer drug resistance was 86% (95% confidence interval [CI] 73.0\u201394.0) for\n rpoB<\/jats:italic>\n , 96% (95% CI 87\u2013100) for\n katG<\/jats:italic>\n and 92% (95% CI 81\u201398) for\n inhA<\/jats:italic>\n . The assay\u2019s specificity was 97% (95% CI 93\u201399) for\n rpoB,<\/jats:italic>\n 98% (95% CI 96\u2013100) for\n katG,<\/jats:italic>\n and 97% (95% CI 93\u201399) for\n inhA.<\/jats:italic>\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion:<\/jats:title>\n \n The diagnostic accuracy of FluoroType MTBDR for the detection of mutations conferring resistance to rifampicin and isoniazid was high compared with that of Genotype MTBDR\n plus<\/jats:italic>\n and demonstrates its suitability as a replacement assay for Genotype MTBDR\n plus.<\/jats:italic>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.4103\/ijmy.ijmy_202_23","type":"journal-article","created":{"date-parts":[[2024,9,15]],"date-time":"2024-09-15T16:00:49Z","timestamp":1726416049000},"page":"258-264","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":3,"title":["Diagnostic Accuracy of FluoroCycler XT MTBDR Assay for Detection of Rifampicin and Isoniazid-resistant Mycobacteria tuberculosis in Clinical Isolates from Kenya"],"prefix":"10.4103","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3608-6892","authenticated-orcid":false,"given":"Zakayo Maingi","family":"Mwangi","sequence":"first","affiliation":[{"name":"Department of Medical Laboratory Sciences, Meru University of Science and Technology, Meru, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samson","family":"Ireri","sequence":"additional","affiliation":[{"name":"National Tuberculosis Reference Laboratory, National Public Health Laboratories, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haron","family":"Opwaka","sequence":"additional","affiliation":[{"name":"National Tuberculosis Reference Laboratory, National Public Health Laboratories, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leon","family":"Otieno","sequence":"additional","affiliation":[{"name":"Molecular Medicine and Infectious Diseases Laboratory, University of Nairobi, Institute of Tropical and Infectious Diseases, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan","family":"Simam","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Sciences, Meru University of Science and Technology, Meru, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank Gekara","family":"Onyambu","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Sciences, Meru University of Science and Technology, Meru, Kenya"},{"name":"Centre for Molecular Biosciences and Genomics, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-9914-3420","authenticated-orcid":false,"given":"Nellie","family":"Mukiri","sequence":"additional","affiliation":[{"name":"National Tuberculosis Reference Laboratory, National Public Health Laboratories, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2024,9,14]]},"reference":[{"key":"R1-20241212","first-page":"2022","article-title":"WHO","year":"2022","journal-title":"Global Tuberculosis Report"},{"key":"R2-20241212","doi-asserted-by":"crossref","first-page":"309","DOI":"10.3389\/fmicb.2019.00309","article-title":"Whole genome sequencing of Mycobacterium tuberculosis clinical isolates from India reveals genetic heterogeneity and region-specific variations that might affect drug susceptibility","volume":"10","author":"Advani","year":"2019","journal-title":"Front Microbiol"},{"key":"R3-20241212","doi-asserted-by":"crossref","first-page":"675","DOI":"10.1016\/S1473-3099(18)30073-2","article-title":"Genetic sequencing for surveillance of drug resistance in tuberculosis in highly endemic countries: A multi-country population-based surveillance study","volume":"18","author":"Zignol","year":"2018","journal-title":"Lancet Infect 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