Remarks

• 1.These recommendations apply to settings where conventional sputum-smear microscopy can be performed.
• 2.TB-LAMP should not replace the use of rapid molecular tests that detect TB and resistance to rifampicin, especially among populations at risk of MDR-TB.
• 3.The test has limited additional diagnostic value over sputum-smear microscopy for testing PLHIV who have signs and symptoms consistent with TB.
• 4.These recommendations apply only to the use of TB-LAMP in testing sputum specimens from patients with signs and symptoms consistent with pulmonary TB.
• 5.These recommendations are extrapolated to using TB-LAMP in children, based on the generalization of data from adults, while acknowledging the difficulties of collecting sputum specimens from children.

Implementation considerations The systematic review supports the use of TB-LAMP as a replacement test for smear microscopy, for diagnosing pulmonary TB in countries with an intermediate or high burden of TB. However, the Xpert MTB/RIF assay should remain the preferred diagnostic test for anyone suspected of having TB, provided that there are sufficient resources and infrastructure to support its use, given the evidence, its ability to simultaneously identify rifampicin resistance and the fact that it is automated.

• Several operational issues accompany the implementation of TB-LAMP; for example, the need for electricity, adequate storage and waste disposal, stock monitoring and temperature control in storage settings where temperatures exceed the manufacturer’s recommendation (currently 30 °C for TB-LAMP).
• TB-LAMP is designed and has been evaluated to detect M. tuberculosis in sputum specimens. Its use with other samples (e.g. urine, serum, plasma, CSF or other body fluids) has not been adequately evaluated.
• Adoption of TB-LAMP does not eliminate the need for smear microscopy, which should be used for monitoring the treatment of patients with drug-susceptible TB. However, the demand for conventional sputum microscopy may decrease in settings where TB-LAMP fully or partially replaces conventional sputum microscopy.
• TB-LAMP should not replace the Xpert MTB/RIF assay because the latter simultaneously detects M. tuberculosis and rifampicin resistance, is automated and is relatively simple to perform.
• In settings where the Xpert MTB/RIF assay cannot be implemented (e.g. because of an inadequate electric supply, or excessive temperatures, humidity or dust), TB-LAMP may be a plausible alternative.