ArticleCommunications medicine2026
Antigen heterogeneity in the development and clinical validation of a multiplexed urine test for tuberculosis.
Article in Communications medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
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Who cites it
3 citing papers in PubMed.
- Review
- Antigen 85B ofVaccines · 2026Review
- Antigen heterogeneity in the development and clinical validation of a multiplexed urine test for tuberculosis.Communications medicine · 2026Article
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
backgroundTuberculosis (TB) is one of the leading causes of death worldwide, even though it is curable using antibiotics. Most people who die of TB never begin treatment because diagnostics are insufficiently sensitive and accessible. We aimed to measure low-abundance biomarkers and diagnose TB in urine.
methodsWe developed and clinically validated a multiplex Single Molecule Array (Simoa) assay to detect TB in urine by measuring two TB biomarkers: lipoarabinomannan (LAM) and antigen 85B (Ag85B). Using antibodies that recognize different epitopes of LAM in a four-plex assay with three LAM and one Ag85B antibody pairs, we trained a model and demonstrated its performance in retrospective cohorts totaling 576 individuals from South Africa, Peru, Vietnam, and Cambodia, including a blinded test cohort (n = 215).
resultsHere we present an assay that classifies samples with 98% specificity, 45% sensitivity overall, and 58% sensitivity among people living with the human immunodeficiency virus (HIV).
conclusionsDifferent antibody pairs detecting different epitopes on LAM report diverging concentrations. We do not find that adding antibody pairs to detect different epitopes on LAM improves the assay's accuracy. Our assay is more sensitive than the existing AlereLAM lateral flow test for TB in HIV-positive individuals, uses safe and accessible urine samples, and represents a step towards an adjunctive diagnostic test to aid clinicians in starting treatment.
Identifiers
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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.