The Use of Loop-Mediated Isothermal Amplification (TB-LAMP) for the Diagnosis of Pulmonary Tuberculosis: Policy Guidance

Excerpt

The WHO End TB Strategy calls for the early diagnosis of TB and universal drug susceptibility testing (DST), highlighting the critical role of laboratories for rapidly and accurately detecting TB and drug resistance. Molecular assays based on nucleic acid amplification techniques such as polymerase chain reaction (PCR) have been developed for rapid TB diagnosis and are being implemented in developing countries. A commercial molecular assay Loopamp MTBC Detection Kit based on loop-mediated isothermal amplification was developed by Eiken Chemical Company Ltd (Tokyo, Japan) for the detection of Mycobacterium tuberculosis complex (TB-LAMP).

TB-LAMP is a manual assay that requires less than one hour to perform and can be read with the naked eye under ultra violet light. Following review of the latest evidence, WHO recommends that TB-LAMP can be used as a replacement for microscopy for the diagnosis of pulmonary TB in adults with signs and symptoms of TB. It can also be considered as a follow-on test to microscopy in adults with signs and symptoms of pulmonary TB, especially when further testing of sputum smear-negative specimens is necessary.