دورية أكاديمية
Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data.
| العنوان: | Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data. |
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| المؤلفون: | Broger T; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany., Koeppel L; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany., Huerga H; Field Epidemiology Department, Epicentre, Paris, France., Miller P; New Zealand Institute for Plant and Food Research, Auckland, New Zealand., Gupta-Wright A; Institute for Global Health, University College London, London, UK; Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK., Blanc FX; Service de Pneumologie, l'institut du thorax, Nantes Université, CHU Nantes, Nantes, France., Esmail A; Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute, University of Cape Town, Cape Town, South Africa; South African MRC Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa., Reeve BWP; DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; South African Medical Research Council Centre for Tuberculosis Research, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa., Floridia M; National Center for Global Health, Istituto Superiore di Sanità, Rome, Italy., Kerkhoff AD; Division of HIV, Infectious Diseases and Global Medicine, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA; Trauma Center, University of California San Francisco, San Francisco, CA, USA; Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA., Ciccacci F; UniCamillus, International University of Health and Medical Science, Rome, Italy; Community of Sant'Egidio, DREAM programme, Rome, Italy., Kasaro MP; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; UNC Global Projects, LLC Zambia, Lusaka, Zambia., Thit SS; Department of Medicine, University of Medicine 2, Yangon, Myanmar., Bastard M; Field Epidemiology Department, Epicentre, Paris, France., Ferlazzo G; Department of Medicine, Médecins Sans Frontières, Paris, France., Yoon C; Department of Medicine, Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA; Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA., Van Hoving DJ; Division of Emergency Medicine, University of Cape Town, Cape Town, South Africa; Division of Emergency Medicine, Stellenbosch University, Cape Town, South Africa., Sossen B; Department of Medicine, University of Cape Town, Cape Town, South Africa; Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa., García JI; Population Health Program, Tuberculosis Group, Texas Biomedical Research Institute, San Antonio, TX, USA., Cummings MJ; Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University Irving Medical Center, New York, NY, USA; Center for Infection and Immunity, Mailman School of Public Health, Columbia University, New York, NY, USA., Wake RM; Centre for Healthcare-Associated Infections, Antimicrobial Resistance and Mycoses, National Institute for Communicable Diseases, Johannesburg, South Africa; Institute for Infection and Immunity, St George's University of London, London, UK., Hanson J; The Kirby Institute, University of New South Wales, Sydney, NSW, Australia., Cattamanchi A; Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA; Department of Medicine, Division of Pulmonary Diseases and Critical Care Medicine, University of California Irvine, Irvine, CA, USA., Meintjes G; Department of Medicine, University of Cape Town, Cape Town, South Africa; Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Maartens G; Department of Medicine, University of Cape Town, Cape Town, South Africa; Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Wood R; Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa., Theron G; DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; South African Medical Research Council Centre for Tuberculosis Research, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa., Dheda K; Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK; Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute, University of Cape Town, Cape Town, South Africa; South African MRC Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa., Olaru ID; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany; Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK., Denkinger CM; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany; German Center for Infection Research, partner site, Heidelberg University Hospital, Heidelberg, Germany. Electronic address: claudia.denkinger@uni-heidelberg.de. |
| مؤلفون مشاركون: | TBYield Study Consortium |
| المصدر: | The Lancet. Global health [Lancet Glob Health] 2023 Jun; Vol. 11 (6), pp. e903-e916. |
| نوع المنشور: | Meta-Analysis; Systematic Review; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101613665 Publication Model: Print Cited Medium: Internet ISSN: 2214-109X (Electronic) Linking ISSN: 2214109X NLM ISO Abbreviation: Lancet Glob Health Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [England] : Elsevier Ltd. 2013- |
| مواضيع طبية MeSH: | Tuberculosis*/diagnosis , Tuberculosis*/drug therapy , HIV Infections*/complications , HIV Infections*/diagnosis , Mycobacterium tuberculosis*, Humans ; Male ; Female ; Sputum/microbiology ; Bayes Theorem ; Cross-Sectional Studies ; Lipopolysaccharides/urine ; Sensitivity and Specificity |
| مستخلص: | Background: Sputum is the most widely used sample to diagnose active tuberculosis, but many people living with HIV are unable to produce sputum. Urine, in contrast, is readily available. We hypothesised that sample availability influences the diagnostic yield of various tuberculosis tests. Methods: In this systematic review and meta-analysis of individual participant data, we compared the diagnostic yield of point-of-care urine-based lipoarabinomannan tests with that of sputum-based nucleic acid amplification tests (NAATs) and sputum smear microscopy (SSM). We used microbiologically confirmed tuberculosis based on positive culture or NAAT from any body site as the denominator and accounted for sample provision. We searched PubMed, Web of Science, Embase, African Journals Online, and clinicaltrials.gov from database inception to Feb 24, 2022 for randomised controlled trials, cross-sectional studies, and cohort studies that assessed urine lipoarabinomannan point-of-care tests and sputum NAATs for active tuberculosis detection in participants irrespective of tuberculosis symptoms, HIV status, CD4 cell count, or study setting. We excluded studies in which recruitment was not consecutive, systematic, or random; provision of sputum or urine was an inclusion criterion; less than 30 participants were diagnosed with tuberculosis; early research assays without clearly defined cutoffs were tested; and humans were not studied. We extracted study-level data, and authors of eligible studies were invited to contribute deidentified individual participant data. The main outcomes were the tuberculosis diagnostic yields of urine lipoarabinomannan tests, sputum NAATs, and SSM. Diagnostic yields were predicted using Bayesian random-effects and mixed-effects meta-analyses. This study is registered with PROSPERO, CRD42021230337. Findings: We identified 844 records, from which 20 datasets and 10 202 participants (4561 [45%] male participants and 5641 [55%] female participants) were included in the meta-analysis. All studies assessed sputum Xpert (MTB/RIF or Ultra, Cepheid, Sunnyvale, CA, USA) and urine Alere Determine TB LAM (AlereLAM, Abbott, Chicago, IL, USA) in people living with HIV aged 15 years or older. Nearly all (9957 [98%] of 10 202) participants provided urine, and 82% (8360 of 10 202) provided sputum within 2 days. In studies that enrolled unselected inpatients irrespective of tuberculosis symptoms, only 54% (1084 of 1993) of participants provided sputum, whereas 99% (1966 of 1993) provided urine. Diagnostic yield was 41% (95% credible interval [CrI] 15-66) for AlereLAM, 61% (95% Crl 25-88) for Xpert, and 32% (95% Crl 10-55) for SSM. Heterogeneity existed across studies in the diagnostic yield, influenced by CD4 cell count, tuberculosis symptoms, and clinical setting. In predefined subgroup analyses, all tests had higher yields in symptomatic participants, and AlereLAM yield was higher in those with low CD4 counts and inpatients. AlereLAM and Xpert yields were similar among inpatients in studies enrolling unselected participants who were not assessed for tuberculosis symptoms (51% vs 47%). AlereLAM and Xpert together had a yield of 71% in unselected inpatients, supporting the implementation of combined testing strategies. Interpretation: AlereLAM, with its rapid turnaround time and simplicity, should be prioritised to inform tuberculosis therapy among inpatients who are HIV-positive, regardless of symptoms or CD4 cell count. The yield of sputum-based tuberculosis tests is undermined by people living with HIV who cannot produce sputum, whereas nearly all participants are able to provide urine. The strengths of this meta-analysis are its large size, the carefully harmonised denominator, and the use of Bayesian random-effects and mixed-effects models to predict yields; however, data were geographically restricted, clinically diagnosed tuberculosis was not considered in the denominator, and little information exists on strategies for obtaining sputum samples. Funding: FIND, the Global Alliance for Diagnostics. Competing Interests: Declaration of interests TB reports patent applications in the field of tuberculosis detection, reports consulting fees from the FINDdx, and is a shareholder of Avelo. GMe was supported by the Wellcome Trust (214321/Z/18/Z and 203135/Z/16/Z) and the South African Research Chairs Initiative of the Department of Science and Technology and National Research Foundation of South Africa (grant number 64787). The opinions, findings, and conclusions expressed in this manuscript reflect those of the authors alone. All other authors declare no competing interests. (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.) |
| التعليقات: | Comment in: Lancet Glob Health. 2023 Jun;11(6):e809-e810. (PMID: 37202010) |
| معلومات مُعتمدة: | MR/M007375/1 United Kingdom MRC_ Medical Research Council; 203135/Z/16/Z United Kingdom WT_ Wellcome Trust; 214321/Z/18/Z United Kingdom WT_ Wellcome Trust |
| فهرسة مساهمة: | Investigator: S Oelofse; D Laureillard; M Andreotti; ON Chilyabanyama; B Welu; L Molfino; SC Mathabire Rücker; E Szumilin; L Cossa; J Meléndez; L Mbuthini; M O'Donnell; JN Jarvis; G Ndlangalavu; K Fielding |
| المشرفين على المادة: | 0 (lipoarabinomannan) 0 (Lipopolysaccharides) |
| تواريخ الأحداث: | Date Created: 20230518 Date Completed: 20230522 Latest Revision: 20240320 |
| رمز التحديث: | 20240320 |
| DOI: | 10.1016/S2214-109X(23)00135-3 |
| PMID: | 37202025 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 2214-109X |
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| DOI: | 10.1016/S2214-109X(23)00135-3 |