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In Vitro Diagnostic Example Use Case: Simple and Rapid Concentration of Urinary Lipoarabinomannan for Sensitive Detection of Active Tuberculosis Disease

Tuberculosis (TB) is a leading cause of death in the world
and the second infectious killer after COVID-19

  • 10.6M cases and 1.6M deaths in 2021

  • 95% of all cases occur in low-and-middle income countries (LMICs)

  • 64% detection rate in 2021

TB Map.png

World Health Organization. Global Tuberculosis Report 2022. 


Existing Active TB Diagnostic Methods Do Not Meet the WHO Target Product Profile

TB Dx Comparison.png

TB Lateral Flow Assay Presents Low Sensitivity Due to Low Lipoarabinomannan (LAM) Concentration in Urine

The Alere Determine TB-LAM Lateral Flow Assay detects the LAM antigen that is released into urine by metabolically active or degenerating M. Tuberculosis bacteria cells. The limit of detection (LoD) of the assay, or minimal concentration of LAM required for accurate diagnosis, is 500-1000 pg/mL [1]. However, LAM concentration in patient urine can be as low as 14 pg/mL [2].

1. Savolainen et al., Clinical Vaccine Immunology. 2013; 20.

2. Garcia et al., Scientific Reports. 2019; 9.


Solution: Concentrate LAM in Urine & Remove Assay-Interfering Molecules

Device Workflow - Hidden Design

100-fold Concentration Lowers the Limit of Detection of the Determine TB LAM LFA 

TB Spiked.png

Increased Test Band Signal on Determine TB-LAM LFA after 100-fold Concentration of TB-Positive Patient Urine

TB Patient LFA.png
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