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Prevalence and predictors of tuberculosis in adults and adolescents with sputum trace Ultra results in two high-burden clinical settings.

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Τίτλος: Prevalence and predictors of tuberculosis in adults and adolescents with sputum trace Ultra results in two high-burden clinical settings.
Συγγραφείς: Visek C; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Dalmat RR; Department of Global Health, University of Washington, Seattle, Washington, USA., Nalutaaya A; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda., Erisa KC; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda., Biché P; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Stein G; Department of Global Health, University of Washington, Seattle, Washington, USA., Ganguloo A; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa.; Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa., Draper R; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa.; Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa., Nantale M; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda., Shapiro AE; Department of Global Health, University of Washington, Seattle, Washington, USA., Wilson D; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa.; Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa., Katamba A; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda.; Clinical Epidemiology & Biostatistics Unit, Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda., Drain PK; Department of Global Health, University of Washington, Seattle, Washington, USA.; Department of Epidemiology, University of Washington, Seattle, Washington, USA., Kendall EA; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Πηγή: MedRxiv : the preprint server for health sciences [medRxiv] 2025 May 18. Date of Electronic Publication: 2025 May 18.
Τύπος έκδοσης: Journal Article; Preprint
Γλώσσα: English
Στοιχεία περιοδικού: Country of Publication: United States NLM ID: 101767986 Publication Model: Electronic Cited Medium: Internet NLM ISO Abbreviation: medRxiv Subsets: PubMed not MEDLINE
Περίληψη: Background: Some patients who test trace-positive on Xpert MTB/RIF Ultra ("Ultra"), a highly sensitive molecular diagnostic platform, may not have tuberculosis (TB) disease. A better understanding of the prevalence of TB disease, associated clinical characteristics, and utility of additional diagnostic tests among people with trace sputum (PWTS) could aid clinical decision-making.
Methods: We enrolled adults and adolescents with trace-positive sputum on initial TB diagnostic evaluation in Uganda and South Africa. Participants were extensively evaluated at enrollment; those with uncertain TB status were followed off treatment, with interval reevaluations by TB clinicians, for up to three months. We assessed TB prevalence and associated patient characteristics and diagnostic results.
Results: Among 311 PWTS, TB was identified by sputum culture at enrollment in 20% of participants (61/311, 95% CI 15-24%). Within three months, 48% (145/301, 95% CI 43-54%) had been judged by clinicians to warrant TB treatment, and among those followed until microbiologic outcomes, 30% (68/227, 95% CI 24-36%) had positive culture and 41% (99/240, 95% CI 35-47%) had positive culture or Ultra. Having TB symptoms, advanced HIV, and no recent TB history were associated with microbiologically-confirmed TB disease, as were an abnormal chest x-ray (in those without recent TB) or elevated CRP.
Conclusions: Roughly half of PWTS were started on TB therapy. Given the low observed mortality rate, some low-risk people with negative results on widely available diagnostic tests could safely defer treatment. Multimodal testing, repeated evaluations, and longer follow-up duration are needed to fully assess the TB burden in PWTS.
Competing Interests: Conflicts of Interest: No conflicts of interest declared for any co-author.
Σχόλια: Update in: Clin Infect Dis. 2026 Jul 8;82(6):e1302-e1310. doi: 10.1093/cid/ciag019.. (PMID: 41858248)
Grant Information: R01 HL153611 United States HL NHLBI NIH HHS
Entry Date(s): Date Created: 20250604 Date Completed: 20260324 Latest Revision: 20260707
Update Code: 20260708
PubMed Central ID: PMC12132140
DOI: 10.1101/2025.05.16.25327787
PMID: 40463552
Βάση Δεδομένων: MEDLINE
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  Data: Prevalence and predictors of tuberculosis in adults and adolescents with sputum trace Ultra results in two high-burden clinical settings.
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  Data: <searchLink fieldCode="AU" term="%22Visek+C%22">Visek C</searchLink>; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Dalmat+RR%22">Dalmat RR</searchLink>; Department of Global Health, University of Washington, Seattle, Washington, USA.<br /><searchLink fieldCode="AU" term="%22Nalutaaya+A%22">Nalutaaya A</searchLink>; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Erisa+KC%22">Erisa KC</searchLink>; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Biché+P%22">Biché P</searchLink>; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Stein+G%22">Stein G</searchLink>; Department of Global Health, University of Washington, Seattle, Washington, USA.<br /><searchLink fieldCode="AU" term="%22Ganguloo+A%22">Ganguloo A</searchLink>; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa.; Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Draper+R%22">Draper R</searchLink>; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa.; Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Nantale+M%22">Nantale M</searchLink>; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Shapiro+AE%22">Shapiro AE</searchLink>; Department of Global Health, University of Washington, Seattle, Washington, USA.<br /><searchLink fieldCode="AU" term="%22Wilson+D%22">Wilson D</searchLink>; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa.; Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Katamba+A%22">Katamba A</searchLink>; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda.; Clinical Epidemiology & Biostatistics Unit, Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Drain+PK%22">Drain PK</searchLink>; Department of Global Health, University of Washington, Seattle, Washington, USA.; Department of Epidemiology, University of Washington, Seattle, Washington, USA.<br /><searchLink fieldCode="AU" term="%22Kendall+EA%22">Kendall EA</searchLink>; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
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  Data: <searchLink fieldCode="JN" term="%22101767986%22">MedRxiv : the preprint server for health sciences</searchLink> [medRxiv] 2025 May 18. <i>Date of Electronic Publication: </i>2025 May 18.
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  Data: Journal Article; Preprint
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  Data: English
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  Data: <i>Country of Publication: </i>United States <i>NLM ID: </i>101767986 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>NLM ISO Abbreviation: </i>medRxiv <i>Subsets: </i>PubMed not MEDLINE
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  Data: Background: Some patients who test trace-positive on Xpert MTB/RIF Ultra ("Ultra"), a highly sensitive molecular diagnostic platform, may not have tuberculosis (TB) disease. A better understanding of the prevalence of TB disease, associated clinical characteristics, and utility of additional diagnostic tests among people with trace sputum (PWTS) could aid clinical decision-making.<br />Methods: We enrolled adults and adolescents with trace-positive sputum on initial TB diagnostic evaluation in Uganda and South Africa. Participants were extensively evaluated at enrollment; those with uncertain TB status were followed off treatment, with interval reevaluations by TB clinicians, for up to three months. We assessed TB prevalence and associated patient characteristics and diagnostic results.<br />Results: Among 311 PWTS, TB was identified by sputum culture at enrollment in 20% of participants (61/311, 95% CI 15-24%). Within three months, 48% (145/301, 95% CI 43-54%) had been judged by clinicians to warrant TB treatment, and among those followed until microbiologic outcomes, 30% (68/227, 95% CI 24-36%) had positive culture and 41% (99/240, 95% CI 35-47%) had positive culture or Ultra. Having TB symptoms, advanced HIV, and no recent TB history were associated with microbiologically-confirmed TB disease, as were an abnormal chest x-ray (in those without recent TB) or elevated CRP.<br />Conclusions: Roughly half of PWTS were started on TB therapy. Given the low observed mortality rate, some low-risk people with negative results on widely available diagnostic tests could safely defer treatment. Multimodal testing, repeated evaluations, and longer follow-up duration are needed to fully assess the TB burden in PWTS.
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  Data: Conflicts of Interest: No conflicts of interest declared for any co-author.
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  Data: Update in: Clin Infect Dis. 2026 Jul 8;82(6):e1302-e1310. doi: 10.1093/cid/ciag019.. (PMID: <searchLink fieldCode="PM" term="%2241858248%22">41858248)</searchLink>
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