Near point-of-care molecular tests for tuberculosis: what will it take to realize their potential?

Tuberculosis persists as the leading cause of death from a single infectious pathogen, with the largest bottleneck in the care cascade being diagnosis and linkage to treatment.1,2 While low-complexity automated nucleic acid amplification tests (NAATs) have comparable diagnostic accuracy to culture and decreased turn-around time, they remain largely confined to district and referral laboratories due to cost and infrastructure demands.2 A further structural constraint is sputum dependence: people living with HIV (PLHIV), young children, and the severely ill (i.e., those with advanced or disseminated pulmonary TB) are at highest risk of missed or delayed diagnosis but are least able to produce sputum on demand.