Remarks

• 1.The reviewed evidence and recommendations apply to the use of AlereLAM only, because other in-house LAM-based assays have not been adequately validated or used outside limited research settings. Any new or generic LAM-based assay should be subject to adequate validation in the settings of intended use.
• 2.All patients with signs and symptoms of pulmonary TB who are capable of producing sputum should submit at least one sputum specimen for Xpert MTB/RIF (Ultra) assay, as their initial diagnostic test. This also includes children and adolescents living with HIV who are able to provide a sputum sample.
• 3.These recommendations also apply to adolescents and children living with HIV, based on generalization of data from adults, while acknowledging that there are very limited data for these population groups.
• 4.LF-LAM should be used as an add-on to clinical judgement in combination with other tests; it should not be used as a replacement or triage test.