Remarks

• This recommendation applies to all people living with HIV, with the caveat of low to moderatecertainty of evidence. However, wherever available, concurrent testing with an LC-aNAATand LF-LAM is recommended for people living with HIV. For more details, see Section 2.3.1.
• This recommendation was extrapolated to children for use with respiratory samples(including induced sputum and gastric aspirate) based on the generalization of data fromadults and very limited data for children, acknowledging the difficulties of collecting sputumspecimens from this population. However, wherever available, concurrent testing with anLC-aNAAT on a respiratory and stool samples is recommended for children. For more details,see Section 2.3.2.
• Data on the use of the test with paediatric stool samples were very limited, and there wereno data on the use of nasopharyngeal aspirates. The recommendation was, therefore, notextrapolated to these sample types.
• No recommendation was made on test use for extrapulmonary TB due to insufficient data.
• As LC-mNAATs do not provide rifampicin-resistance results, all positive diagnostic tests forTB require follow-up and referral for DST for, at a minimum, rifampicin.

Implementation considerations

• Diagnostic products in the low-complexity classes of tests should be prequalified by WHO or approved by another regulator before clinical use.
• Diagnostic test manufacturers, laboratory and programme managers, and policy-makers should be educated on the WHO PQ process for TB IVDs.
• Ensuring sufficient volume and specimen quality is important to obtain accurate results.
• Safe waste disposal of used test consumables needs to be planned in advance to minimize environmental risk.