Antigen detection in a lateral flow format (biomarker-based detection)

The urine lateral flow lipoarabinomannan (LF-LAM) assay is an immunocapture assay based on the detection of the mycobacterial lipoarabinomannan antigen in urine. For specific populations, LF-LAM may be used together with other approved TB diagnostics tests and affords a distinct advantage as a point-of-care test. Although the assay lacks sensitivity, it can be used as a fast bedside rule-in test for people living with HIV, especially in urgent cases where a rapid TB diagnosis is critical for the person’s survival. The Alere Determine TB LAM Ag (Abbott, Chicago, United States) is currently the only commercially available urine lipoarabinomannan test endorsed by WHO (76).

Recommendations for the use of LF-LAM distinguish between inpatients and outpatients (see Box 4.4). The recommendations apply only to the use of Alere Determine TB LAM Ag because newer assays have not been adequately validated or used outside limited research settings.

Box 4.4 WHO recommendations on use of lateral flow lipoarabinomannan assays

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