{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T16:34:11Z","timestamp":1785429251833,"version":"3.56.0"},"reference-count":30,"publisher":"American Society for Microbiology","issue":"1","license":[{"start":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T00:00:00Z","timestamp":1768348800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T00:00:00Z","timestamp":1768348800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"Shanghai Sailing Program","award":["22YF1445700"],"award-info":[{"award-number":["22YF1445700"]}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82202568"],"award-info":[{"award-number":["82202568"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82102406"],"award-info":[{"award-number":["82102406"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002858","name":"China Postdoctoral Science Foundation","doi-asserted-by":"publisher","award":["2024M750519"],"award-info":[{"award-number":["2024M750519"]}],"id":[{"id":"10.13039\/501100002858","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Shanghai's three-year plan for Public Health Talent Training","award":["GWVI-11.2-YQ03"],"award-info":[{"award-number":["GWVI-11.2-YQ03"]}]},{"name":"Major Project of Guangzhou National Laboratory","award":["GZNL2024A01030-1"],"award-info":[{"award-number":["GZNL2024A01030-1"]}]},{"name":"Independent Project of Shanghai Sci-Tech Inno Center for Infection & Immunity","award":["SSIII-202404"],"award-info":[{"award-number":["SSIII-202404"]}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2026,1,14]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Effective tuberculosis (TB) management relies on prompt diagnosis of\n                      <jats:italic toggle=\"yes\">Mycobacterium tuberculosis<\/jats:italic>\n                      complex (MTBC) and associated drug resistance. The Sanity 2.0 assay is a high-resolution melting assay designed for direct respiratory sample testing, enabling simultaneous detection of MTBC and resistance to rifampicin (RIF), isoniazid (INH), and fluoroquinolones (FQ) in a single step. This study evaluated its diagnostic performance in two registered multicenter trials among bacteriologically confirmed TB patients. Diagnostic performance was evaluated for MTBC detection, as well as for the identification of resistance to RIF, INH, and FQ, using phenotypic drug susceptibility testing, whole-genome sequencing, and a composite reference standard. Agreement analyses were conducted between the Sanity 2.0 assay and Xpert MTB\/RIF and Xpert MTB\/XDR. Among 611 patients, the Sanity 2.0 assay detected MTBC in 563 patients, exhibiting a sensitivity of 92.1% (95% CI: 89.7\u201394.0). For detecting resistance to RIF, INH, and FQ, sensitivities exceeded 90%, with specificities of 95.8% (95% CI: 88.5\u201398.6), 100.0% (95% CI: 96.4\u2013100.0), and 97.8% (95% CI: 93.8\u201399.3) against the composite reference standard, respectively. The agreement with Xpert MTB\/RIF for RIF detection was 98.6% (95% CI: 96.9\u201399.3). For INH and FQ resistance, the agreement with Xpert MTB\/XDR was 92.0% (95% CI: 88.5\u201394.5) and 94.3% (95% CI: 91.2\u201396.3), respectively. The Sanity 2.0 assay is a rapid and user-friendly platform capable of detecting both MTBC and key drug resistance. It demonstrated good diagnostic performance and could potentially be an effective alternative to guide individualized anti-TB treatment, especially in resource-limited settings.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>\n                      Rapid and accurate detection of both\n                      <jats:italic toggle=\"yes\">Mycobacterium tuberculosis<\/jats:italic>\n                      complex (MTBC) and key drug resistance is critical to improving tuberculosis treatment outcomes and reducing transmission. However, current molecular diagnostic workflows often require sequential testing, which can delay the initiation of effective and individualized therapy. We evaluated the Sanity 2.0 assay, an integrated high-resolution melting test that simultaneously detects MTBC and resistance to rifampicin, isoniazid, and fluoroquinolone resistance directly from respiratory samples in about 2\u20133 hours. The assay demonstrated excellent performance, with MTBC detection sensitivity of 92.1% and drug resistance sensitivities exceeding 90% and specificities over 95% against a composite reference standard, as well as strong concordance with World Health Organization-endorsed molecular assays. Implementation of the Sanity 2.0 assay could streamline TB diagnostic workflows; enable rapid, single-step resistance profiling; and facilitate timely, individualized treatment\u2014particularly in resource-limited settings where rapid and comprehensive resistance testing remains a critical unmet need.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.01299-25","type":"journal-article","created":{"date-parts":[[2025,12,10]],"date-time":"2025-12-10T14:08:32Z","timestamp":1765375712000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":0,"title":["Diagnostic performance of the Sanity 2.0 assay to detect resistance to rifampicin, isoniazid, and fluoroquinolones in tuberculosis"],"prefix":"10.1128","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3096-413X","authenticated-orcid":false,"given":"Zhen","family":"Feng","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01zntxs11","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Shanghai Medical College, Fudan University","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shijia","family":"Ge","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01zntxs11","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Shanghai Medical College, Fudan University","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peiwen","family":"Miao","sequence":"additional","affiliation":[{"name":"Department of infectious disease, Lanxi People\u2019s Hospital","place":["Jinhua, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mei","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Tuberculosis, Affiliated Hospital of Zunyi Medical University","place":["Guizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Tuberculosis, Affiliated Hospital of Zunyi Medical University","place":["Guizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rong","family":"Li","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01zntxs11","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Infectious Diseases, Shanghai 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Press of Military Medical Sciences, Beijing."},{"key":"e_1_3_4_28_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02170-16"},{"key":"e_1_3_4_29_2","doi-asserted-by":"publisher","DOI":"10.1086\/379328"},{"key":"e_1_3_4_30_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkm061"},{"key":"e_1_3_4_31_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(18)30104-X"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01299-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01299-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T14:01:03Z","timestamp":1768399263000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.01299-25"}},"subtitle":[],"editor":[{"given":"Melissa B.","family":"Miller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,1,14]]},"references-count":30,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1,14]]}},"alternative-id":["10.1128\/jcm.01299-25"],"URL":"https:\/\/doi.org\/10.1128\/jcm.01299-25","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,14]]},"assertion":[{"value":"2025-09-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-30","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-10","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01299-25"}}