Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data
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. In this systematic re...
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| Veröffentlicht in: | The Lancet global health 2023-06, Vol.11 (6), p.e903-e916 |
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| creator | Broger, Tobias Koeppel, Lisa Huerga, Helena Miller, Poppy Gupta-Wright, Ankur Blanc, François-Xavier Esmail, Aliasgar Reeve, Byron W P Floridia, Marco Kerkhoff, Andrew D Ciccacci, Fausto Kasaro, Margaret P Thit, Swe Swe Bastard, Mathieu Ferlazzo, Gabriella Yoon, Christina Van Hoving, Daniël J Sossen, Bianca García, Juan Ignacio Cummings, Matthew J Wake, Rachel M Hanson, Josh Cattamanchi, Adithya Meintjes, Graeme Maartens, Gary Wood, Robin Theron, Grant Dheda, Keertan Olaru, Ioana Diana Denkinger, Claudia M Oelofse, Suzette Laureillard, Didier Andreotti, Mauro Chilyabanyama, Obvious Nchimunya Welu, Benjamin Molfino, Lucas Mathabire Rücker, Sekai Chenai Szumilin, Elisabeth Cossa, Loide Meléndez, Johanna Mbuthini, Linda O'Donnell, Max Jarvis, Joseph N Ndlangalavu, Gcobisa Fielding, Katherine |
| description | 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.
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.
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. |
| doi_str_mv | 10.1016/S2214-109X(23)00135-3 |
| format | Article |
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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.
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.
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.
FIND, the Global Alliance for Diagnostics.</description><identifier>ISSN: 2214-109X</identifier><identifier>EISSN: 2214-109X</identifier><identifier>DOI: 10.1016/S2214-109X(23)00135-3</identifier><identifier>PMID: 37202025</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Bayes Theorem ; Cross-Sectional Studies ; Female ; HIV Infections - complications ; HIV Infections - diagnosis ; Humans ; Lipopolysaccharides - urine ; Male ; Mycobacterium tuberculosis ; Sensitivity and Specificity ; Sputum - microbiology ; Tuberculosis - diagnosis ; Tuberculosis - drug therapy</subject><ispartof>The Lancet global health, 2023-06, Vol.11 (6), p.e903-e916</ispartof><rights>2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license</rights><rights>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.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c412t-e4eef281a01deefd533c8179c687df0826fe27cf8a966657532f806ae3a15f013</citedby><cites>FETCH-LOGICAL-c412t-e4eef281a01deefd533c8179c687df0826fe27cf8a966657532f806ae3a15f013</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,861,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37202025$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Broger, Tobias</creatorcontrib><creatorcontrib>Koeppel, Lisa</creatorcontrib><creatorcontrib>Huerga, Helena</creatorcontrib><creatorcontrib>Miller, Poppy</creatorcontrib><creatorcontrib>Gupta-Wright, Ankur</creatorcontrib><creatorcontrib>Blanc, François-Xavier</creatorcontrib><creatorcontrib>Esmail, Aliasgar</creatorcontrib><creatorcontrib>Reeve, Byron W P</creatorcontrib><creatorcontrib>Floridia, Marco</creatorcontrib><creatorcontrib>Kerkhoff, Andrew D</creatorcontrib><creatorcontrib>Ciccacci, Fausto</creatorcontrib><creatorcontrib>Kasaro, Margaret P</creatorcontrib><creatorcontrib>Thit, Swe Swe</creatorcontrib><creatorcontrib>Bastard, Mathieu</creatorcontrib><creatorcontrib>Ferlazzo, Gabriella</creatorcontrib><creatorcontrib>Yoon, Christina</creatorcontrib><creatorcontrib>Van Hoving, Daniël J</creatorcontrib><creatorcontrib>Sossen, Bianca</creatorcontrib><creatorcontrib>García, Juan Ignacio</creatorcontrib><creatorcontrib>Cummings, Matthew J</creatorcontrib><creatorcontrib>Wake, Rachel M</creatorcontrib><creatorcontrib>Hanson, Josh</creatorcontrib><creatorcontrib>Cattamanchi, Adithya</creatorcontrib><creatorcontrib>Meintjes, Graeme</creatorcontrib><creatorcontrib>Maartens, Gary</creatorcontrib><creatorcontrib>Wood, Robin</creatorcontrib><creatorcontrib>Theron, Grant</creatorcontrib><creatorcontrib>Dheda, Keertan</creatorcontrib><creatorcontrib>Olaru, Ioana Diana</creatorcontrib><creatorcontrib>Denkinger, Claudia M</creatorcontrib><creatorcontrib>Oelofse, Suzette</creatorcontrib><creatorcontrib>Laureillard, Didier</creatorcontrib><creatorcontrib>Andreotti, Mauro</creatorcontrib><creatorcontrib>Chilyabanyama, Obvious Nchimunya</creatorcontrib><creatorcontrib>Welu, Benjamin</creatorcontrib><creatorcontrib>Molfino, Lucas</creatorcontrib><creatorcontrib>Mathabire Rücker, Sekai Chenai</creatorcontrib><creatorcontrib>Szumilin, Elisabeth</creatorcontrib><creatorcontrib>Cossa, Loide</creatorcontrib><creatorcontrib>Meléndez, Johanna</creatorcontrib><creatorcontrib>Mbuthini, Linda</creatorcontrib><creatorcontrib>O'Donnell, Max</creatorcontrib><creatorcontrib>Jarvis, Joseph N</creatorcontrib><creatorcontrib>Ndlangalavu, Gcobisa</creatorcontrib><creatorcontrib>Fielding, Katherine</creatorcontrib><creatorcontrib>TBYield Study Consortium</creatorcontrib><title>Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data</title><title>The Lancet global health</title><addtitle>Lancet Glob Health</addtitle><description>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.
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.
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.
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.
FIND, the Global Alliance for Diagnostics.</description><subject>Bayes Theorem</subject><subject>Cross-Sectional Studies</subject><subject>Female</subject><subject>HIV Infections - complications</subject><subject>HIV Infections - diagnosis</subject><subject>Humans</subject><subject>Lipopolysaccharides - urine</subject><subject>Male</subject><subject>Mycobacterium tuberculosis</subject><subject>Sensitivity and Specificity</subject><subject>Sputum - microbiology</subject><subject>Tuberculosis - diagnosis</subject><subject>Tuberculosis - drug therapy</subject><issn>2214-109X</issn><issn>2214-109X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUctu1TAQtRCIVqWfAPKyLAJ-3DgJG4RaoJUqseAhdtZce1yMEjvYTqv7Sfwlzr2lYsd4MSPrPDRzCHnO2SvOuHr9WQi-aTgbvp8J-ZIxLttGPiLHD9-P_5mPyGnOP1mtYZCi656SI9kJVl97TH5feLgJMRdv6M7jaGl0dEk-IB39HCHB1oc4QQgQKARL87yUZaJl2WIyyxizz7RgLpn6QGeM87gyb324oXe-_KCXV9_eUKB5lwtOsNokvPV4txebsEADAcbdKlOdfbCVaxcY6Qypov0MoVALBZ6RJw7GjKf3_YR8_fD-y_llc_3p49X5u-vGbLgoDW4Qneg5MG7rZFspTc-7wai-s471QjkUnXE9DEqptmulcD1TgBJ46-olT8jZQXdO8ddSN9OTzwbHEQLGJeuqrTrFpBQV2h6gJsWcEzo9Jz9B2mnO9BqU3gel1xS0kHoflJaV9-LeYtlOaB9Yf2OpgLcHANZF67WSzsZjMGh9QlO0jf4_Fn8AYaum3g</recordid><startdate>202306</startdate><enddate>202306</enddate><creator>Broger, Tobias</creator><creator>Koeppel, Lisa</creator><creator>Huerga, Helena</creator><creator>Miller, Poppy</creator><creator>Gupta-Wright, Ankur</creator><creator>Blanc, François-Xavier</creator><creator>Esmail, Aliasgar</creator><creator>Reeve, Byron W P</creator><creator>Floridia, Marco</creator><creator>Kerkhoff, Andrew D</creator><creator>Ciccacci, Fausto</creator><creator>Kasaro, Margaret P</creator><creator>Thit, Swe Swe</creator><creator>Bastard, Mathieu</creator><creator>Ferlazzo, Gabriella</creator><creator>Yoon, Christina</creator><creator>Van Hoving, Daniël J</creator><creator>Sossen, Bianca</creator><creator>García, Juan Ignacio</creator><creator>Cummings, Matthew J</creator><creator>Wake, Rachel M</creator><creator>Hanson, Josh</creator><creator>Cattamanchi, Adithya</creator><creator>Meintjes, Graeme</creator><creator>Maartens, Gary</creator><creator>Wood, Robin</creator><creator>Theron, Grant</creator><creator>Dheda, Keertan</creator><creator>Olaru, Ioana Diana</creator><creator>Denkinger, Claudia M</creator><creator>Oelofse, Suzette</creator><creator>Laureillard, Didier</creator><creator>Andreotti, Mauro</creator><creator>Chilyabanyama, Obvious Nchimunya</creator><creator>Welu, Benjamin</creator><creator>Molfino, Lucas</creator><creator>Mathabire Rücker, Sekai Chenai</creator><creator>Szumilin, Elisabeth</creator><creator>Cossa, Loide</creator><creator>Meléndez, Johanna</creator><creator>Mbuthini, Linda</creator><creator>O'Donnell, Max</creator><creator>Jarvis, Joseph N</creator><creator>Ndlangalavu, Gcobisa</creator><creator>Fielding, Katherine</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202306</creationdate><title>Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data</title><author>Broger, Tobias ; Koeppel, Lisa ; Huerga, Helena ; Miller, Poppy ; Gupta-Wright, Ankur ; Blanc, François-Xavier ; Esmail, Aliasgar ; Reeve, Byron W P ; Floridia, Marco ; Kerkhoff, Andrew D ; Ciccacci, Fausto ; Kasaro, Margaret P ; Thit, Swe Swe ; Bastard, Mathieu ; Ferlazzo, Gabriella ; Yoon, Christina ; Van Hoving, Daniël J ; Sossen, Bianca ; García, Juan Ignacio ; Cummings, Matthew J ; Wake, Rachel M ; Hanson, Josh ; Cattamanchi, Adithya ; Meintjes, Graeme ; Maartens, Gary ; Wood, Robin ; Theron, Grant ; Dheda, Keertan ; Olaru, Ioana Diana ; Denkinger, Claudia M ; Oelofse, Suzette ; Laureillard, Didier ; Andreotti, Mauro ; Chilyabanyama, Obvious Nchimunya ; Welu, Benjamin ; Molfino, Lucas ; Mathabire Rücker, Sekai Chenai ; Szumilin, Elisabeth ; Cossa, Loide ; Meléndez, Johanna ; Mbuthini, Linda ; O'Donnell, Max ; Jarvis, Joseph N ; Ndlangalavu, Gcobisa ; Fielding, Katherine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c412t-e4eef281a01deefd533c8179c687df0826fe27cf8a966657532f806ae3a15f013</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Bayes Theorem</topic><topic>Cross-Sectional Studies</topic><topic>Female</topic><topic>HIV Infections - complications</topic><topic>HIV Infections - diagnosis</topic><topic>Humans</topic><topic>Lipopolysaccharides - urine</topic><topic>Male</topic><topic>Mycobacterium tuberculosis</topic><topic>Sensitivity and Specificity</topic><topic>Sputum - microbiology</topic><topic>Tuberculosis - diagnosis</topic><topic>Tuberculosis - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Broger, Tobias</creatorcontrib><creatorcontrib>Koeppel, Lisa</creatorcontrib><creatorcontrib>Huerga, Helena</creatorcontrib><creatorcontrib>Miller, Poppy</creatorcontrib><creatorcontrib>Gupta-Wright, Ankur</creatorcontrib><creatorcontrib>Blanc, François-Xavier</creatorcontrib><creatorcontrib>Esmail, Aliasgar</creatorcontrib><creatorcontrib>Reeve, Byron W P</creatorcontrib><creatorcontrib>Floridia, Marco</creatorcontrib><creatorcontrib>Kerkhoff, Andrew D</creatorcontrib><creatorcontrib>Ciccacci, Fausto</creatorcontrib><creatorcontrib>Kasaro, Margaret P</creatorcontrib><creatorcontrib>Thit, Swe Swe</creatorcontrib><creatorcontrib>Bastard, Mathieu</creatorcontrib><creatorcontrib>Ferlazzo, Gabriella</creatorcontrib><creatorcontrib>Yoon, Christina</creatorcontrib><creatorcontrib>Van Hoving, Daniël J</creatorcontrib><creatorcontrib>Sossen, Bianca</creatorcontrib><creatorcontrib>García, Juan Ignacio</creatorcontrib><creatorcontrib>Cummings, Matthew J</creatorcontrib><creatorcontrib>Wake, Rachel M</creatorcontrib><creatorcontrib>Hanson, Josh</creatorcontrib><creatorcontrib>Cattamanchi, Adithya</creatorcontrib><creatorcontrib>Meintjes, Graeme</creatorcontrib><creatorcontrib>Maartens, Gary</creatorcontrib><creatorcontrib>Wood, Robin</creatorcontrib><creatorcontrib>Theron, Grant</creatorcontrib><creatorcontrib>Dheda, Keertan</creatorcontrib><creatorcontrib>Olaru, Ioana Diana</creatorcontrib><creatorcontrib>Denkinger, Claudia M</creatorcontrib><creatorcontrib>Oelofse, Suzette</creatorcontrib><creatorcontrib>Laureillard, Didier</creatorcontrib><creatorcontrib>Andreotti, Mauro</creatorcontrib><creatorcontrib>Chilyabanyama, Obvious Nchimunya</creatorcontrib><creatorcontrib>Welu, Benjamin</creatorcontrib><creatorcontrib>Molfino, Lucas</creatorcontrib><creatorcontrib>Mathabire Rücker, Sekai Chenai</creatorcontrib><creatorcontrib>Szumilin, Elisabeth</creatorcontrib><creatorcontrib>Cossa, Loide</creatorcontrib><creatorcontrib>Meléndez, Johanna</creatorcontrib><creatorcontrib>Mbuthini, Linda</creatorcontrib><creatorcontrib>O'Donnell, Max</creatorcontrib><creatorcontrib>Jarvis, Joseph N</creatorcontrib><creatorcontrib>Ndlangalavu, Gcobisa</creatorcontrib><creatorcontrib>Fielding, Katherine</creatorcontrib><creatorcontrib>TBYield Study Consortium</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet global health</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Broger, Tobias</au><au>Koeppel, Lisa</au><au>Huerga, Helena</au><au>Miller, Poppy</au><au>Gupta-Wright, Ankur</au><au>Blanc, François-Xavier</au><au>Esmail, Aliasgar</au><au>Reeve, Byron W P</au><au>Floridia, Marco</au><au>Kerkhoff, Andrew D</au><au>Ciccacci, Fausto</au><au>Kasaro, Margaret P</au><au>Thit, Swe Swe</au><au>Bastard, Mathieu</au><au>Ferlazzo, Gabriella</au><au>Yoon, Christina</au><au>Van Hoving, Daniël J</au><au>Sossen, Bianca</au><au>García, Juan Ignacio</au><au>Cummings, Matthew J</au><au>Wake, Rachel M</au><au>Hanson, Josh</au><au>Cattamanchi, Adithya</au><au>Meintjes, Graeme</au><au>Maartens, Gary</au><au>Wood, Robin</au><au>Theron, Grant</au><au>Dheda, Keertan</au><au>Olaru, Ioana Diana</au><au>Denkinger, Claudia M</au><au>Oelofse, Suzette</au><au>Laureillard, Didier</au><au>Andreotti, Mauro</au><au>Chilyabanyama, Obvious Nchimunya</au><au>Welu, Benjamin</au><au>Molfino, Lucas</au><au>Mathabire Rücker, Sekai Chenai</au><au>Szumilin, Elisabeth</au><au>Cossa, Loide</au><au>Meléndez, Johanna</au><au>Mbuthini, Linda</au><au>O'Donnell, Max</au><au>Jarvis, Joseph N</au><au>Ndlangalavu, Gcobisa</au><au>Fielding, Katherine</au><aucorp>TBYield Study Consortium</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data</atitle><jtitle>The Lancet global health</jtitle><addtitle>Lancet Glob Health</addtitle><date>2023-06</date><risdate>2023</risdate><volume>11</volume><issue>6</issue><spage>e903</spage><epage>e916</epage><pages>e903-e916</pages><issn>2214-109X</issn><eissn>2214-109X</eissn><abstract>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.
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.
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.
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.
FIND, the Global Alliance for Diagnostics.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>37202025</pmid><doi>10.1016/S2214-109X(23)00135-3</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2214-109X |
| ispartof | The Lancet global health, 2023-06, Vol.11 (6), p.e903-e916 |
| issn | 2214-109X 2214-109X |
| language | eng |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Bayes Theorem Cross-Sectional Studies Female HIV Infections - complications HIV Infections - diagnosis Humans Lipopolysaccharides - urine Male Mycobacterium tuberculosis Sensitivity and Specificity Sputum - microbiology Tuberculosis - diagnosis Tuberculosis - drug therapy |
| title | 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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