{"doi":"10.1016/j.cmi.2025.04.013","title":"Diagnostic accuracy of Truenat MTB Ultima on sputum for pulmonary tuberculosis diagnosis in an HIV-endemic setting","abstract":"OBJECTIVES: Assess Truenat MTB Ultima (Ultima) diagnostic accuracy, alongside standard-of-care Truenat MTB Plus (MTB Plus) and Xpert MTB/RIF Ultra (Ultra) tests, for pulmonary tuberculosis (TB) diagnosis in a high-burden setting. We secondarily evaluated Truenat MTB-RIF Dx (MTB-RIF Dx) on Ultima- or MTB Plus-positive samples for rifampicin susceptibility diagnosis. METHODS: Adults (≥18 years; n = 498) with presumptive TB self-presenting to primary care clinics in Cape Town, South Africa (19/02/2016-22/02/2023) provided sputa. The microbiological reference standard was a single culture for TB and MTBDRplus on an isolate for rifampicin susceptibility. RESULTS: In total, 54% (n = 269) of the participants had HIV, and 42% (n = 210) had previous TB. The proportion of Ultima and MTB Plus unsuccessful results was 14% (95% CI 11, 16) and 20% (17, 23), respectively, with at least half resolving upon retesting the same eluate. In a three-way analysis, Ultima, MTB Plus, and Ultra had TB sensitivities of 90% (85, 93), 84% (78, 88), and 92% (87, 95) and specificities of 85% (80, 88), 95% (92, 97), and 95% (92, 97). Ultima specificity did not improve with Ultra in the reference standard. MTB-RIF Dx had high unsuccessful result rates that varied if done on the day of DNA extraction or on Ultima- [18% (10, 26) vs. 44% (35, 51) if after day of extraction] or MTB Plus-positive eluates [9% (3, 16) vs. 27% (18, 35)]. Same day rifampicin susceptibility testing was often unsuccessful in samples with the \"very low\" semiquantitation category reported by Ultima [75% (65, 86)] or MTB Plus [73% (58, 89)] but had 100% (40, 100) sensitivity and 99% (96, 100) specificity (on both MTB Plus- or Ultima-positive DNA). Reagent lot variation in unsuccessful and false positive results was observed. DISCUSSION: Ultima met the minimum sensitivity recommended by the WHO for TB detection, but specificity, reagent lot variation, and unsuccessful results were suboptimal.","journal":"Clinical Microbiology and Infection","year":2025,"id":512875,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":11,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9007,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1352748,"name":"Arthur Chiwaya","orcid":"0000-0003-0357-9663","position":1,"is_corresponding":false},{"id":1228275,"name":"Welile V. Dube-Nwamba","orcid":"0000-0003-4231-1467","position":2,"is_corresponding":false},{"id":660389,"name":"Byron W P Reeve","orcid":"0000-0002-3332-3477","position":3,"is_corresponding":false},{"id":661148,"name":"Zaida Palmer","orcid":null,"position":4,"is_corresponding":false},{"id":775758,"name":"Hridesh Mishra","orcid":"0000-0002-8572-2736","position":5,"is_corresponding":false},{"id":1176121,"name":"Desiree L Mbu","orcid":null,"position":6,"is_corresponding":false},{"id":1353060,"name":"Nondumiso Lushozi","orcid":null,"position":7,"is_corresponding":false},{"id":1353061,"name":"Zola Nkwanyana","orcid":null,"position":8,"is_corresponding":false},{"id":302718,"name":"Morten Rühwald","orcid":"0000-0002-1597-441X","position":9,"is_corresponding":false},{"id":252288,"name":"Adam Penn‐Nicholson","orcid":"0000-0002-1883-0059","position":10,"is_corresponding":false},{"id":89652,"name":"Robin M. Warren","orcid":"0000-0001-5741-7358","position":11,"is_corresponding":false},{"id":244855,"name":"Grant Theron","orcid":"0000-0002-9216-2415","position":12,"is_corresponding":false},{"id":1352747,"name":"Shima M. Abdulgader","orcid":"0000-0003-1911-3729","position":0,"is_corresponding":true}],"reference_count":15,"raw_metadata":null,"created_at":"2026-07-19T02:48:11.233009Z","pmid":"40254059","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}