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| Verfasst von: | Székely, Rita [VerfasserIn]  |
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| | Sossen, Bianca [VerfasserIn] |
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| | Mukoka, Madalo [VerfasserIn] |
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| | Muyoyeta, Monde [VerfasserIn] |
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| | Nakabugo, Elizabeth [VerfasserIn] |
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| | Hella, Jerry [VerfasserIn] |
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| | Nguyen, Hung Van [VerfasserIn] |
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| | Ubolyam, Sasiwimol [VerfasserIn] |
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| | Chikamatsu, Kinuyo [VerfasserIn] |
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| | Macé, Aurélien [VerfasserIn] |
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| | Vermeulen, Marcia [VerfasserIn] |
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| | Centner, Chad M. [VerfasserIn] |
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| | Nyangu, Sarah [VerfasserIn] |
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| | Sanjase, Nsala [VerfasserIn] |
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| | Sasamalo, Mohamed [VerfasserIn] |
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| | Dinh, Huong Thi [VerfasserIn] |
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| | Ngo, The Anh [VerfasserIn] |
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| | Manosuthi, Weerawat [VerfasserIn] |
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| | Jirajariyavej, Supunnee [VerfasserIn] |
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| | Mitarai, Satoshi [VerfasserIn] |
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| | Nguyen, Nhung Viet [VerfasserIn] |
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| | Avihingsanon, Anchalee [VerfasserIn] |
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| | Reither, Klaus [VerfasserIn] |
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| | Nakiyingi, Lydia [VerfasserIn] |
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| | Kerkhoff, Andrew D. [VerfasserIn] |
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| | MacPherson, Peter [VerfasserIn] |
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| | Meintjes, Graeme [VerfasserIn] |
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| | Denkinger, Claudia M. [VerfasserIn] |
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| | Ruhwald, Morten [VerfasserIn] |
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| Titel: | Prospective multicentre accuracy evaluation of the FUJIFILM SILVAMP TB LAM test for the diagnosis of tuberculosis in people living with HIV demonstrates lot-to-lot variability |
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| Verf.angabe: | Rita Székely, Bianca Sossen, Madalo Mukoka, Monde Muyoyeta, Elizabeth Nakabugo, Jerry Hella, Hung Van Nguyen, Sasiwimol Ubolyam, Kinuyo Chikamatsu, Aurélien Macé, Marcia Vermeulen, Chad M. Centner, Sarah Nyangu, Nsala Sanjase, Mohamed Sasamalo, Huong Thi Dinh, The Anh Ngo, Weerawat Manosuthi, Supunnee Jirajariyavej, Satoshi Mitarai, Nhung Viet Nguyen, Anchalee Avihingsanon, Klaus Reither, Lydia Nakiyingi, Andrew D. Kerkhoff, Peter MacPherson, Graeme Meintjes, Claudia M. Denkinger, Morten Ruhwald, FujiLAM Study Consortium |
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| E-Jahr: | 2024 |
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| Jahr: | May 31, 2024 |
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| Umfang: | 15 S. |
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| Illustrationen: | Illustrationen |
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| Fussnoten: | Gesehen am 05.12.2024 |
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| Titel Quelle: | Enthalten in: PLOS ONE |
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| Ort Quelle: | San Francisco, California, US : PLOS, 2006 |
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| Jahr Quelle: | 2024 |
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| Band/Heft Quelle: | 19(2024), 5, Artikel-ID e0303846, Seite 1-15 |
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| ISSN Quelle: | 1932-6203 |
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| Abstract: | There is an urgent need for rapid, non-sputum point-of-care diagnostics to detect tuberculosis. This prospective trial in seven high tuberculosis burden countries evaluated the diagnostic accuracy of the point-of-care urine-based lipoarabinomannan assay FUJIFILM SILVAMP TB LAM (FujiLAM) among inpatients and outpatients living with HIV. Diagnostic performance of FujiLAM was assessed against a mycobacterial reference standard (sputum culture, blood culture, and Xpert Ultra from urine and sputum at enrollment, and additional sputum culture ≤7 days from enrollment), an extended mycobacterial reference standard (eMRS), and a composite reference standard including clinical evaluation. Of 1637 participants considered for the analysis, 296 (18%) were tuberculosis positive by eMRS. Median age was 40 years, median CD4 cell count was 369 cells/ul, and 52% were female. Overall FujiLAM sensitivity was 54·4% (95% CI: 48·7-60·0), overall specificity was 85·2% (83·2-87·0) against eMRS. Sensitivity and specificity estimates varied between sites, ranging from 26·5% (95% CI: 17·4%-38·0%) to 73·2% (60·4%-83·0%), and 75·0 (65·0%-82·9%) to 96·5 (92·1%-98·5%), respectively. Post-hoc exploratory analysis identified significant variability in the performance of the six FujiLAM lots used in this study. Lot variability limited interpretation of FujiLAM test performance. Although results with the current version of FujiLAM are too variable for clinical decision-making, the lipoarabinomannan biomarker still holds promise for tuberculosis diagnostics. The trial is registered at clinicaltrials.gov (NCT04089423). |
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| DOI: | doi:10.1371/journal.pone.0303846 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
kostenfrei: Volltext: https://doi.org/10.1371/journal.pone.0303846 |
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| | kostenfrei: Volltext: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0303846 |
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| | DOI: https://doi.org/10.1371/journal.pone.0303846 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| Sach-SW: | HIV diagnosis and management |
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| | Mycobacterium tuberculosis |
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| | Nontuberculous mycobacteria |
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| | Sputum |
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| | Tuberculosis |
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| | Tuberculosis diagnosis and management |
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| | Urine |
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| | Virus testing |
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| K10plus-PPN: | 1910957933 |
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| Verknüpfungen: | → Zeitschrift |
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Prospective multicentre accuracy evaluation of the FUJIFILM SILVAMP TB LAM test for the diagnosis of tuberculosis in people living with HIV demonstrates lot-to-lot variability / Székely, Rita [VerfasserIn]; May 31, 2024 (Online-Ressource)
