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. Extrapulmonary TB—which accounts for 20–40% of TB cases in high-burden settings and is more common among PLHIV—poses an additional diagnostic challenge that sputum-based tools cannot adequately address. Tests that address all three barriers, high cost, platform accessibility, and specimen flexibility, offer a credible path to closing the massive TB diagnostic gap.²

In February 2026, WHO recommended, for the first time, near point-of-care NAATs (nPOC-NAATs) (1) on sputum as an initial diagnostic test for adults and adolescents with symptoms or screen-positive of pulmonary TB, replacing smear microscopy, and (2) on tongue swabs as an alternative when sputum cannot be obtained.³