Trial reportPloS one2019
Sensitive electrochemiluminescence (ECL) immunoassays for detecting lipoarabinomannan (LAM) and ESAT-6 in urine and serum from tuberculosis patients.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
39 citing papers in PubMed, 1 synthesis or guideline pooled it, 73 citations in OpenAlex.
- Diagnostic value of Lipoarabinomannan antigen for detecting Mycobacterium tuberculosis in adults and children with or without HIV infection.Journal of clinical laboratory analysis · 2022Pooled it
- Trial
- Diagnostic accuracy of 3 urine lipoarabinomannan tuberculosis assays in HIV-negative outpatients.The Journal of clinical investigation · 2020Trial
- Bronchoalveolar Lavage Fluid Lipoarabinomannan as a Rapid Rule-Out Tool for Smear-Negative Pulmonary Tuberculosis in a Nonhuman Immunodeficiency Virus-Predominant, High-Burden Setting: A Prospective Study.Open forum infectious diseases · 2026Article
- Novel human monoclonal antibodies with enhanced sensitivity for lipoarabinomannan antigens present in urines of TB patients.bioRxiv : the preprint server for biology · 2026Article
- Comparison of two analytical platforms for quantification of neuroglial biomarkers in blood samples: a single molecule array and an electrochemiluminescence assay.Scientific reports · 2026Article
- (Cu-S)Mikrochimica acta · 2026Article
- Exploiting thioether reactivity to label mycobacterial glycans.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Observational
- Innovative COVID-19 Point-of-Care Diagnostics Suitable for Tuberculosis Diagnosis: A Scoping Review.Journal of clinical medicine · 2024Article
- Real-world diagnostic accuracy of lipoarabinomannan in three non-sputum biospecimens for pulmonary tuberculosis disease.EBioMedicine · 2024Article
- Prospective Analysis of urINe LAM to Eliminate NTM Sputum Screening (PAINLESS) study: Rationale and trial design for testing urine lipoarabinomannan as a marker of NTM lung infection in cystic fibrosis.medRxiv : the preprint server for health sciences · 2024Article
- Improving the diagnosis of active tuberculosis: a novel approach using magnetic particle-based chemiluminescence LAM assay.BMC pulmonary medicine · 2024Article
- Diagnostic accuracy of Lipoarabinomannan detection by lateral flow assay in pleural tuberculosis.BMC infectious diseases · 2024Article
- Microneedle patch-based enzyme-linked immunosorbent assay to quantify protein biomarkers of tuberculosis.Biomedical microdevices · 2024Article
- Clinical evaluation of a novel plasma pTau217 electrochemiluminescence immunoassay in Alzheimer's disease.Scientific reports · 2024Article
- Urine lipoarabinomannan concentrations among HIV-negative adults with pulmonary or extrapulmonary tuberculosis disease in Vietnam.PLOS global public health · 2024Article
- Collected Thoughts on Mycobacterial Lipoarabinomannan, a Cell Envelope Lipoglycan.Pathogens (Basel, Switzerland) · 2023Review
- Development of Gold-Nanoparticle-Based Lateral Flow Immunoassays for Rapid Detection of TB ESAT-6 and CFP-10.Biosensors · 2023Article
- Advancement in COVID-19 detection using nanomaterial-based biosensors.Exploration (Beijing, China) · 2023Review
Corrections and comments
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Authors and funding
14 authors at 6 institutions in 4 countries.
Funding
Abstract
backgroundTuberculosis (TB) infection was responsible for an estimated 1.3 million deaths in 2017. Better diagnostic tools are urgently needed. We sought to determine whether accurate TB antigen detection in blood or urine has the potential to meet the WHO target product profiles for detection of active TB. MATERIALS AND
methodsWe developed Electrochemiluminescence (ECL) immunoassays for Lipoarabinomannan (LAM) and ESAT-6 detection with detection limits in the pg/ml range and used them to compare the concentrations of the two antigens in the urine and serum of 81 HIV-negative and -positive individuals with presumptive TB enrolled across diverse geographic sites.
resultsLAM and ESAT-6 overall sensitivities in urine were 93% and 65% respectively. LAM and ESAT-6 overall sensitivities in serum were 55% and 46% respectively. Overall specificity was ≥97% in all assays. Sensitivities were higher in HIV-positive compared to HIV-negative patients for both antigens and both sample types, with signals roughly 10-fold higher on average in urine than in serum. The two antigens showed similar concentration ranges within the same sample type and correlated.
conclusionsLAM and ESAT-6 can be detected in the urine and serum of TB patients, regardless of the HIV status and further gains in clinical sensitivity may be achievable through assay and reagent optimization. Accuracy in urine was higher with current methods and has the potential to meet the WHO accuracy target if the findings can be transferred to a point-of-care TB test.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.