{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T14:06:08Z","timestamp":1785420368622,"version":"3.56.0"},"reference-count":22,"publisher":"American Society for Microbiology","issue":"1","license":[{"start":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T00:00:00Z","timestamp":1767657600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T00:00:00Z","timestamp":1767657600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1171455"],"award-info":[{"award-number":["OPP1171455"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2026,1,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Despite the availability of molecular diagnostics, only 48% of newly diagnosed tuberculosis (TB) cases were confirmed using nucleic acid amplification tests in 2023. The MAX Multi Drug Resistant Tuberculosis (MAX MDR-TB) assay detects\n                      <jats:italic toggle=\"yes\">Mycobacterium tuberculosis<\/jats:italic>\n                      complex (MTBC) and resistance to rifampicin (RIF) and isoniazid (INH), but data on clinical performance are limited. This study assessed the assay\u2019s performance on sputum and tongue swabs (TSs). The assay was evaluated for MTBC detection and RIF and INH resistance profiling on sputum using liquid culture as the reference and Xpert MTB\/RIF Ultra (Ultra) as a comparator. Diagnostic accuracy for MTBC detection on TS was also assessed. Among 335 participants (56% HIV prevalence), MAX MDR-TB on raw sputum showed an overall sensitivity and specificity of 88.7% (95% confidence interval [CI]: 78.1\u201395.3) and 98.2% (95% CI: 95.8\u201399.4) compared with culture and strong agreement with Ultra (Cohen\u2019s kappa = 0.853). A total of 15\/55 (27%) sputum samples were classified as \u201cMTB low POS.\u201d Two false RIF-resistant results were observed. INH resistance was missed in two cases. Although specimen numbers were small, TS demonstrated better diagnostic accuracy when using a diluted sample treatment reagent (STR) (66%) buffer. Although the MAX MDR-TB assay demonstrated good agreement with Ultra, Ultra identified more TB cases. Preliminary findings suggest that TS, particularly with a diluted STR buffer, may be a feasible specimen type, but larger studies are required. The high frequency of MTB low POS results highlights the importance of technology assessment by TB programs prior to implementation to minimize repeat testing and enhance diagnostic reliability.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>\n                      This study evaluates the accuracy of the BD MAXTM MDR-TB assay in detecting\n                      <jats:italic toggle=\"yes\">Mycobacterium tuberculosis<\/jats:italic>\n                      complex using sputum and tongue swabs from individuals being assessed for tuberculosis (TB) in South Africa. Rapid and reliable TB diagnosis is crucial for early treatment and preventing transmission. The MAX Multi Drug Resistant Tuberculosis (MAX MDR-TB) assay is a fully automated molecular test that can simultaneously detect TB and drug resistance, offering a potentially faster and more efficient alternative for TB diagnosis. By assessing its performance on different specimen types, this study provides valuable insights into its reliability in clinical settings. Although the MAX MDR-TB assay demonstrated strong agreement with the Xpert MTB\/RIF Ultra assay, it identified fewer TB cases. Tongue swabs were also shown to be a feasible specimen type for testing. This research contributes to global TB control efforts by evaluating advanced diagnostics that could streamline testing, reduce delays, and ultimately improve patient outcomes.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.01802-25","type":"journal-article","created":{"date-parts":[[2025,11,28]],"date-time":"2025-11-28T13:00:52Z","timestamp":1764334852000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":0,"title":["Diagnostic accuracy of the BD MAX MDR-TB assay on sputum and tongue swabs for\n                    <i>Mycobacterium tuberculosis<\/i>\n                    complex detection in adults under investigation for TB in South Africa"],"prefix":"10.1128","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1590-198X","authenticated-orcid":true,"given":"Anura","family":"David","sequence":"first","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand","place":["Johannesburg, South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lyndel","family":"Singh","sequence":"additional","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand","place":["Johannesburg, South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel Pedro","family":"da Silva","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00znvbk37","id-type":"ROR","asserted-by":"publisher"}],"name":"National Priority Programmes, National Health Laboratory Services","place":["Johannesburg, South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keneilwe","family":"Peloakgosi-Shikwambani","sequence":"additional","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand","place":["Johannesburg, South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zanele","family":"Nsingwane","sequence":"additional","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand","place":["Johannesburg, South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Violet","family":"Molepo","sequence":"additional","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand","place":["Johannesburg, South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Stevens","sequence":"additional","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand","place":["Johannesburg, South Africa"]},{"id":[{"id":"https:\/\/ror.org\/00znvbk37","id-type":"ROR","asserted-by":"publisher"}],"name":"National Priority Programmes, National Health Laboratory Services","place":["Johannesburg, South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley Erica","family":"Scott","sequence":"additional","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand","place":["Johannesburg, South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","unstructured":"World Health Organisation. 2024. Global tuberculosis report 2024. World Health Organisation. https:\/\/www.who.int\/teams\/global-tuberculosis-programme\/tb-reports\/global-tuberculosis-report-2024."},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41564-023-01365-3"},{"key":"e_1_3_3_4_2","unstructured":"World Health Organization. 2021. Module 3: diagnostics rapid diagnostic for tuberculosis detection WHO consolidated guidelines on tuberculosis. World Health Organization. https:\/\/www.who.int\/publications\/i\/item\/9789240029415."},{"key":"e_1_3_3_5_2","unstructured":"Treatment Action Group. 2023. Pipeline report 2023. https:\/\/www.treatmentactiongroup.org\/wp-content\/uploads\/2023\/11\/2023_pipeline_TB_diagnostics_final.pdf."},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02168-20"},{"key":"e_1_3_3_7_2","unstructured":"NICD. 2023. Yes we can end TB. https:\/\/www.nicd.ac.za\/wp-content\/uploads\/2023\/03\/World-TB-Day-2023.pdf."},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.12701\/jyms.2024.00024"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmoldx.2020.06.013"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2021.1997594"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz932"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(23)00469-2"},{"key":"e_1_3_3_13_2","doi-asserted-by":"crossref","unstructured":"Andama A Steadman AE Ahls C Cangelosi GA David A Vos M Heichman K Kato-Maeda M Penn-Nicholson A Olson A Scott L Turnbull L Wood R Weigel K Cattamanchi A. 2024. Consensus standard operating procedure for collection of tongue swabs for TB diagnostics. Available from: https:\/\/www.protocols.io\/view\/consensus-standard-operating-procedure-for-collect-kxygxyw54l8j\/v1","DOI":"10.17504\/protocols.io.kxygxyw54l8j\/v1"},{"key":"e_1_3_3_14_2","unstructured":"South African National Department of Health. 2023. National guideline on the treatment of tuberculosis infection. https:\/\/www.nicd.ac.za\/wp-content\/uploads\/2024\/12\/National-TB-Infection-Treatment-Guidelines_2023.pdf."},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.3389\/fnut.2023.1194682"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.11613\/BM.2012.031"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00537-19"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11904-011-0083-7"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01885-20"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13073-019-0660-8"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1004237"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00421-22"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00019-24"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.01802-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.01802-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T14:05:25Z","timestamp":1767708325000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.01802-25"}},"subtitle":[],"editor":[{"given":"Ana","family":"Cabrera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,1,6]]},"references-count":22,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1,6]]}},"alternative-id":["10.1128\/spectrum.01802-25"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.01802-25","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,6]]},"assertion":[{"value":"2025-06-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-28","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01802-25"}}