Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in people living with HIV

Bjerrum, Stephanie; Schiller, Ian; Dendukuri, Nandini; Kohli, Mikashmi; Nathavitharana, Ruvandhi R; Zwerling, Alice A; Denkinger, Claudia M; Steingart, Karen R; Shah, Maunank

doi:10.1002/14651858.cd011420.pub3

Cited by 186Tuberculosis Research and EpidemiologyInfectious Diseases and TuberculosisDiagnosis and treatment of tuberculosis

Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in people living with HIV

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Bjerrum, Stephanie, Schiller, Ian, Dendukuri, Nandini, Kohli, Mikashmi, Nathavitharana, Ruvandhi R, Zwerling, Alice A, Denkinger, Claudia M, Steingart, Karen R +1 more·2019·Cochrane Database of Systematic Reviews

DOI 10.1002/14651858.cd011420.pub3PMC PMC6802713

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Abstract

BACKGROUND: The lateral flow urine lipoarabinomannan (LF-LAM) assay Alere Determine™ TB LAM Ag is recommended by the World Health Organization (WHO) to help detect active tuberculosis in HIV-positive people with severe HIV disease. This review update asks the question, "does new evidence justify the use of LF-LAM in a broader group of people?", and is part of the WHO process for updating guidance on the use of LF-LAM. OBJECTIVES: To assess the accuracy of LF-LAM for the diagnosis of active tuberculosis among HIV-positive adults with signs and symptoms of tuberculosis (symptomatic participants) and among HIV-positive adults irrespective of signs and symptoms of tuberculosis (unselected participants not assessed for tuberculosis signs and symptoms).The proposed role for LF-LAM is as an add on to clinical judgement and with other tests to assist in diagnosing tuberculosis. SEARCH METHODS: We searched the Cochrane Infectious Diseases Group Specialized Register; MEDLINE, Embase, Science Citation Index, Web of Science, Latin American Caribbean Health Sciences Literature, Scopus, the WHO International Clinical Trials Registry Platform, the International Standard Randomized Controlled Trial Number Registry, and ProQuest, without language restriction to 11 May 2018. SELECTION CRITERIA: Randomized trials, cross-sectional, and observational cohort studies that evaluated LF-LAM for active tuberculosis (pulmonary and extrapulmonary) in HIV-positive adults. We included studies that used the manufacturer's recommended threshold for test positivity, either the updated reference card with four bands (grade 1 of 4) or the corresponding prior reference card grade with five bands (grade 2 of 5). The reference standard was culture or nucleic acid amplification test from any body site (microbiological). We considered a higher quality reference standard to be one in which two or more specimen types were evaluated for tuberculosis diagnosis and a lower quality reference standard to be one in which only one specimen type was evaluated. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data using a standardized form and REDCap electronic data capture tools. We appraised the quality of studies using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool and performed meta-analyses to estimate pooled sensitivity and specificity using a bivariate random-effects model and a Bayesian approach. We analyzed studies enrolling strictly symptomatic participants separately from those enrolling unselected participants. We investigated pre-defined sources of heterogeneity including the influence of CD4 count and clinical setting on the accuracy estimates. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 15 unique studies (nine new studies and six studies from the original review that met the inclusion criteria): eight studies among symptomatic adults and seven studies among unselected adults. All studies were conducted in low- or middle-income countries. Risk of bias was high in the patient selection and reference standard domains, mainly because studies excluded participants unable to produce sputum and used a lower quality reference standard.Participants with tuberculosis symptomsLF-LAM pooled sensitivity (95% credible interval (CrI) ) was 42% (31% to 55%) (moderate-certainty evidence) and pooled specificity was 91% (85% to 95%) (very low-certainty evidence), (8 studies, 3449 participants, 37% with tuberculosis).For a population of 1000 people where 300 have microbiologically-confirmed tuberculosis, the utilization of LF-LAM would result in: 189 to be LF-LAM positive: of these, 63 (33%) would not have tuberculosis (false-positives); and 811 to be LF-LAM negative: of these, 174 (21%) would have tuberculosis (false-negatives).By clinical setting, pooled sensitivity was 52% (40% to 64%) among inpatients versus 29% (17% to 47%) among outpatients; and pooled specificity was 87% (78% to 93%) among inpatients versus 96% (91% to 99%) among outpatients. Stratified by CD4 cell count, pooled sensitivity increased, and specificity decreased with lower CD4 cell count.Unselected participants not assessed for signs and symptoms of tuberculosisLF-LAM pooled sensitivity was 35% (22% to 50%), (moderate-certainty evidence) and pooled specificity was 95% (89% to 96%), (low-certainty evidence), (7 studies, 3365 participants, 13% with tuberculosis).For a population of 1000 people where 100 have microbiologically-confirmed tuberculosis, the utilization of LF-LAM would result in: 80 to be LF-LAM positive: of these, 45 (56%) would not have tuberculosis (false-positives); and 920 to be LF-LAM negative: of these, 65 (7%) would have tuberculosis (false-negatives).By clinical setting, pooled sensitivity was 62% (41% to 83%) among inpatients versus 31% (18% to 47%) among outpatients; pooled specificity was 84% (48% to 96%) among inpatients versus 95% (87% to 99%) among outpatients. Stratif

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The accuracy of urinary LAM detection is improved among people living with HIV with advanced immunosuppression.
“The accuracy of urinary LAM detection is improved among people living with HIV with advanced immunosuppression (Bjerrum 2019).”
From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Bjerrum 2019

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142nd Annual Meeting of the American Neurological Association
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Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in HIV-positive adults
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Diagnostic accuracy of urine AlereLAM and FujiLAM assays for diagnosing active tuberculosis in people living with HIV: a systematic review and meta-analysis
Saman, A. A. M., Wardhani, P., -, A., & Rahman, L. N. (2026) · Journal of Associated Medical Sciences · doi:10.66285/jams.2026.089

Authors: Bjerrum, S., Schiller, I., Dendukuri, N., Kohli, M., Nathavitharana, R. R., Zwerling, A. A., Denkinger, C. M., Steingart, K. R., & Shah, M.
Affiliations: University of Southern Denmark (DK)
McGill University Health Centre (CA)
McGill University (CA)
Beth Israel Deaconess Medical Center (US)
University of Ottawa (CA)
FIND (CH)
Liverpool School of Tropical Medicine (GB)
Johns Hopkins University (US)
Corresponding author: Bjerrum, Stephanie
ORCID: Bjerrum, Stephanie
Dendukuri, Nandini
Kohli, Mikashmi
Nathavitharana, Ruvandhi R
Zwerling, Alice A
Denkinger, Claudia M
Steingart, Karen R
Shah, Maunank
Venue: Cochrane Database of Systematic Reviews
Publisher: Wiley
Published: 2019-10-21
Volume: 2019
Issue: 10
Pages: CD011420-CD011420
ISSN: 1361-6137 (ISSN-L)
1465-1858
DOI: 10.1002/14651858.cd011420.pub3
PMC: PMC6802713
OpenAlex: W2982248582
Cited by: 186
References: 141
Citations by year: 2026: 15 · 2025: 31 · 2024: 29 · 2023: 22 · 2022: 35 · 2021: 28 · 2020: 24 · 2019: 2
FWCI: 3.12
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-sa
Locations: Cochrane Database of Systematic Reviews (publishedVersion, cc-by-nc-sa)
Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
PubMed Central (publishedVersion, cc-by-nc)
PubMed (publishedVersion)
LSTM Online Archive (Liverpool School of Tropical Medicine) (acceptedVersion)
University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, cc-by-nc-sa)
Funders: National Institute of Allergy and Infectious Diseases (K23AI132648)
Topics: Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
Health Sciences › Medicine › Surgery › Infectious Diseases and Tuberculosis
Health Sciences › Medicine › Surgery › Diagnosis and treatment of tuberculosis
Keywords: lipoarabinomannan, lateral flow assay, active tuberculosis, HIV, tuberculosis diagnosis, diagnostic accuracy, sensitivity and specificity, extrapulmonary tuberculosis, CD4 count

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Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in people living with HIV

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