Determine™ TB LAM Ag
Abbott Rapid Diagnostics

Solution Overview & Benefits
Rapid test that detects Mycobacterium tuberculosis via a urine-based strip test—no need for sputum, complex machines, or lab facilities.
Particularly valuable for people living with HIV and very low CD4 counts (<100 cells/µL), where conventional methods underperform.
Results in about 25 minutes, easy to interpret using a visual reference card for band intensity. Compatible with minimal training; ideal for decentralised, resource-limited settings. Can be used together with smear microscopy or Xpert MTB/RIF to increase overall case detection rates
Benefits Summary:
- Fast and easy to use
- Requires only urine—safe and accessible sample
- No special equipment or electricity needed
- Works well in severely immunosuppressed HIV patients
- Supports decentralized TB testing and earlier treatment
History & Development
Originally developed by Alere Inc. (now part of Abbott) as an immunochromatographic kit targeting LAM antigen in urine samples.
WHO issued policy recommendations in 2015, endorsing its use for people living with HIV who are seriously ill or have low CD4 cell counts (<100 cells/µL). Included in global TB guidelines and distributed through the Global Drug Facility for high-burden settings.
Availability
- Available: worldwide
- Price: contact solution provider (cost per strip is relatively low, especially when procured via GDF or bulk purchase channels)
Specifications
- Sample Type: Urine (60 µL)
- Test Type: Lateral flow immunochromatographic strip
- Detection Target: Lipoarabinomannan (LAM) antigen from M. tuberculosis
- Time to Result: ~25 minutes
- Result Readout: Visual band, scored 0 to 5 using reference card (recommend using Grade 2 cut-off for specificity)
- Training Minimum: Basic instruction in handling urine and visual band interpretation
- Storage Conditions: Room temperature, shelf life per product label
Additional Information
- Not recommended as a general screening tool but highly impactful for HIV-positive hospitalized individuals or those with advanced immunosuppression
- Distributed globally through Abbott Diagnostics and procurement via Stop TB Partnership’s Global Drug Facility
- Contact form
Similar solutions...
Get in Touch!
Get in touch with us by filling out the form or emailing us at contact@techxlab.org.
