Bibliographic Info
GuidelineWHO guidelines on the management of advanced HIV disease
Year of Publication2025
Issuing InstitutionWorld Health Organization
Recommendation
Status
Maintained
Recommended in favor
Strong
Certainty of evidence
Low
For adults and adolescents with HIV who have signs or symptoms of TB, screen positive for TB, are seriously ill or have advanced HIV disease, concurrent testing using low-complexity automated nucleic acid amplification tests (NAATs) on respiratory samples and LF-LAM on urine should be used as the initial diagnostic strategy for diagnosing TB, rather than low complexity automated NAATs on respiratory samples alone.
Notes and Remarks
- Serious illness in people living with HIV is defined based on any of the following symptoms:respiratory rate ≥30 breaths per minute, temperature ≥39 °C, heart rate ≥120 beats perminute or unable to walk unaided.• Advanced HIV disease is defined in people living with HIV who have a CD4 cell count of<200 cells/mm3 or presenting with a WHO Stage 3/4 AIDS-defining illness.• This concurrent testing recommendation supersedes prior guidance on using LF-LAM forpeople living with HIV and the use of a single molecular test for diagnosis of TB in this group.• This recommendation is strong despite the low certainty of evidence because the findingsindicate large desirable effects (i.e. rapid and accurate diagnosis of TB in a highly vulnerablepopulation – people living with HIV – in whom diagnosing TB is often challenging) over smallundesirable effects (i.e. negative consequences of this testing strategy).• The LC-aNAAT products for which eligible data met the class-based performance criteria forthis recommendation were Xpert MTB/RIF Ultra and Truenat MTB Plus. Data for performanceof Truenat MTB Plus and MTB-RIF Dx were only available for testing among persons livingwith HIV without concurrent LF-LAM testing. Adults and adolescents living with HIV and children living with HIV
- Global and national HIV and TB programmes need to communicate regularly and clearly, indicating responsibilities for concurrent testing for people living with HIV.
- Concurrent testing maximizes the diagnostic access and accuracy, is a more efficient way to address the needs of people living with HIV and is preferred even if the testing workload may increase.
- A positive result on either test is sufficient to confirm a TB diagnosis.
- Loss to follow-up for the second test result should be monitored and prevented. Patients should be given information to understand the concurrent testing approach and the need for follow-up.
- The LF-LAM performed in point-of-care settings may be the first positive result and is sufficient to make the initial diagnosis. A respiratory sample is still required for detecting rifampicin resistance. It is also required when the LF-LAM is negative.
- Efforts are needed to improve access to LF-LAM.
- LF-LAM does not differentiate Mycobacterium tuberculosis from other mycobacterial species. However, the LAM antigen detected in a clinical sample in TB endemic areas is most likely attributable to Mycobacterium tuberculosis. When LF-LAM is commonly positive without positive low-complexity automated NAATs, further investigation of the quality of testing and local epidemiology of non-TB mycobacteria and extrapulmonary TB in the tested population is warranted to understand the difference.
- Bands on the LF-LAM test strip should be interpreted using the manufacturer’s reading card to minimize incorrect results.
- LF-LAM test strips must be stored according to the manufacturer’s instructions (such as between 2°C and 30°C) in sealed bags and not used after expiration.
- Infrastructure to collect a urine sample privately should be available. Patients should be instructed how to properly and sanitarily collect urine to minimize environmental contamination and prevent false-positive results.
- Trained personnel are required to perform the LF-LAM test at the point of care.
- Similar to all WHO-recommended TB diagnostics, quality assurance programmes for both tests are required.
- LF-LAM is designed to detect mycobacterial LAM antigen in human urine. Other samples (such as sputum, serum, plasma, CSF and other body fluids) or pooled urine specimens should not be used
Also Featured In
This recommendation also appears in the following guidelines:
Originally Developed
Guideline
WHO consolidated guidelines on tuberculosis: module 3: diagnosis
Year2025
InstitutionWorld Health Organization