Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data

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; Hoving, D.J. van; Sossen, Bianca; García, Juan Ignacio García; Cummings, Matthew J.; Wake, Rachel; Hanson, Josh; Cattamanchi, Adithya; Meintjes, Graeme; Maartens, Gary; Wood, Robin; Theron, Grant; Dheda, Keertan; Olaru, Ioana D.; Denkinger, Claudia M.; Oelofse, Suzette; Laureillard, Didier; Andreotti, Mauro; Chilyabanyama, Obvious Nchimunya; Welu, Benjamin; Molfino, Lucas; Rücker, Sekai Chenai Mathabire; Szumilin, Elisabeth; Cossa, Loide; Meléndez, Johanna; Mbuthini, Linda; O’Donnell, Max R; Jarvis, Joseph N; Ndlangalavu, Gcobisa; Fielding, Katherine

doi:10.1016/s2214-109x(23)00135-3

Cited by 27 publications

(8 citation statements)

References 54 publications

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“…Currently, it is necessary to perform several tests to have a TB diagnosis. Despite the availability of new diagnostic techniques, the smear test and the culture of the microorganism are the goldstandard tests, but these are delivering late diagnoses (Broger et al, 2023). The LAM urine assay was seen as a potentially revolutionary diagnostic for active TB (Flores et al, 2021).…”

Section: Discussionmentioning

confidence: 99%

Diagnostic value of chemiluminescence for urinary lipoarabinomannan antigen assay in active tuberculosis: insights from a retrospective study

Huang,

Niu,

Zhang

et al. 2023

Front. Cell. Infect. Microbiol.

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PurposeThis study aimed to assess the efficacy of chemiluminescence-based urinary lipoarabinomannan (LAM) antigen assay as a diagnostic tool for identifying active tuberculosis.MethodsA retrospective study was conducted on 166 Tuberculosis (TB), 22 Non-Tuberculous Mycobacteria (NTM), 69 Non-TB cases, and 73 healthy controls from Zhangjiagang First Peoples Hospital between July 2022 and November 2022. Clinical and laboratory data were collected, including urine samples for LAM antigen detection, sputum samples and pleural effusion for GeneXpert, TB-DNA, and culture.ResultsTB group exhibited a higher LAM positivity rate (P < 0.001). CD4 count and diabetes as independent factors influencing the diagnostic accuracy of LAM. The LAM assay showed a sensitivity of 50.6% and a specificity of 95.65%. Notably, LAM’s sensitivity was superior to TB-DNA (50.60% vs. 38.16%, P < 0.05). LAM’s PTB detection rate was 51.7%, superior to TB-DNA (P = 0.047). Moreover, in EPTB cases, the LAM detection rate was 42.11%, surpassing Gene Xpert (P = 0.042), as well as exceeding the detection rates of TB-DNA and sputum culture.ConclusionLAM antigen detection using chemiluminescence has demonstrated outstanding clinical diagnostic value for active TB, especially in the diagnosis of extrapulmonary TB. The convenience of sample collection in this diagnostic approach allows for widespread application in the clinical diagnosis of active tuberculosis, particularly in cases of EPTB and sputum-negative patients.

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Section: Discussionmentioning

confidence: 99%

Diagnostic value of chemiluminescence for urinary lipoarabinomannan antigen assay in active tuberculosis: insights from a retrospective study

Huang,

Niu,

Zhang

et al. 2023

Front. Cell. Infect. Microbiol.

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“…We therefore suggest that current guidelines should be made more user-friendly and easily interpretable in clinical practice. Recent systematic reviews using individual patient data further suggest the Determine LAM testing in all HIV-positive medical inpatients be implemented (31,32). A barrier to POC Determine LAM testing not previously described was delayed HIV screening of patients with unknown HIV status.…”

Section: Discussionmentioning

confidence: 99%

Use of the urine Determine LAM test in the context of tuberculosis diagnosis among inpatients with HIV in Ghana: a mixed methods study

Åhsberg,

Tersbøl,

Puplampu

et al. 2024

Front. Public Health

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BackgroundThe urine Determine LAM test has the potential to identify tuberculosis (TB) and reduce early mortality among people living with HIV. However, implementation of the test in practice has been slow. We aimed to understand how a Determine LAM intervention was received and worked in a Ghanaian in-hospital context.Design/MethodsNested in a Determine LAM intervention study, we conducted a two-phase explanatory sequential mixed methods study at three hospitals in Ghana between January 2021 and January 2022. We performed a quantitative survey with 81 healthcare workers (HCWs), four qualitative focus-group discussions with 18 HCWs, and 15 in-depth HCW interviews. Integration was performed at the methods and analysis level. Descriptive analysis, qualitative directed content analysis, and mixed methods joint display were used.ResultsThe gap in access to TB testing when relying on sputum GeneXpert MTB/Rif alone was explained by difficulties in obtaining sputum samples and an in-hospital system that relies on relatives. The Determine LAM test procedure was experienced as easy, and most eligible patients received a test. HCWs expressed that immediate access to Determine LAM tests empowered them in rapid diagnosis. The HCW survey confirmed that bedside was the most common place for Determine LAM testing, but qualitative interviews with nurses revealed concerns about patient confidentiality when performing and disclosing the test results at the bedside. Less than half of Determine LAM-positive patients were initiated on TB treatment, and qualitative data identified a weak link in the communication of the Determine LAM results. Moreover, HCWs were reluctant to initiate Determine LAM-positive patients on TB treatment due to test specificity concerns. The Determine LAM intervention did not have an impact on the time to TB treatment as expected, but patients were, in general, initiated on TB treatment rapidly. We further identified a barrier to accessing TB treatment during weekends and that treatment by tradition is administrated early in the morning.ConclusionThe Determine LAM testing was feasible and empowered HCWs in the management of HIV-associated TB. Important gaps in routine care and Determine LAM-enhanced TB care were often explained by the context. These findings may inform in-hospital quality improvement work and scale-up of Determine LAM in similar settings.

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“…For a century, acid-fast staining of sputum smears assessed by microscopy of patients suspected of having TB has been the standard diagnostic test, but it has low sensitivity. Some adults, HIV + individuals, and most children cannot produce sputum ( Broger et al, 2023 ; Davies and Pai, 2008 ), and TB diagnosis in children is difficult, often requiring gastric lavage, which is not possible in high-burden TB countries ( WHO, 2022a ). For a more definitive diagnosis, cultures of organisms from sputum have been used, but it takes weeks for cultures to become positive and patients often fail to report back to the clinic, especially in high-burden TB countries.…”

Section: Diagnostics and Prediction Of Tbmentioning

confidence: 99%

A half-century of research on tuberculosis: Successes and challenges

Bloom¹

2023

Journal of Experimental Medicine

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Great progress has been made over the past half-century, but TB remains a formidable global health problem, particularly in low- and middle-income countries. Understanding the mechanisms of pathogenesis and necessary and sufficient conditions for protection are critical. The need for inexpensive and sensitive point-of-care diagnostic tests for earlier detection of infection and disease, shorter and less-toxic drug regimens for drug-sensitive and -resistant TB, and a more effective vaccine than BCG is immense. New and better tools, greater support for international research, collaborations, and training will be required to dramatically reduce the burden of this devastating disease which still kills 1.6 million people annually.

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Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data

Cited by 27 publications

References 54 publications

Diagnostic value of chemiluminescence for urinary lipoarabinomannan antigen assay in active tuberculosis: insights from a retrospective study

Diagnostic value of chemiluminescence for urinary lipoarabinomannan antigen assay in active tuberculosis: insights from a retrospective study

Use of the urine Determine LAM test in the context of tuberculosis diagnosis among inpatients with HIV in Ghana: a mixed methods study

A half-century of research on tuberculosis: Successes and challenges

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