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

Currently, the only WHO-endorsed product (Fig. 1) in this new nPOC-NAAT class is the MTB Nucleic Acid Test Card with the MiniDock Ultra device by Pluslife Biotech (Guangzhou, China). This technology currently does not detect drug-resistance.

Fig. 1.

Mobile clinic with MTB Nucleic Acid Test Card with the Minidock device by Pluslife Biotech (Guangzhou, China). Credit: with permission from Pluslife, China.

nPOC-NAATs represent three distinct advances.³ First, the platform itself (Fig. 1) is battery-operable by non-specialist staff, which enables placement at primary health centers and community sites where molecular testing has never been feasible. Second, the MiniDock test is available at a combined capital cost of USD 330 and a per-test cost of USD 3.60 through the Global Drug Facility, a cost that is substantially lower than any other WHO-endorsed NAAT.⁴ Third, compatibility with tongue swabs extends testing to populations for whom existing molecular tools have never been an option at a sensitivity that exceeds that of sputum microscopy by about 20%.³ Sputum remains the preferred specimen for those who can produce it, given sensitivity of sputum swabs comparable to that of sputum testing on WHO-recommended low-complexity NAATs.

Together, these characteristics constitute a genuine shift in the diagnostic armamentarium that can help high-burden countries achieve universal access to WHO-recommended molecular testing⁵: for the first time, an affordable molecular platform can plausibly function at the community level and for the people least able to meet the demands of existing tools. Performance with tongue swabs exceeds minimum WHO Target Product Profile targets,³ though sensitivity in paucibacillary disease, the presentation most likely in the populations tongue swabs are designed to reach, warrants close attention as real-world data accumulate.

Bench performance does not automatically translate into population-level impact.^6,7 Rollout cannot simply substitute tongue swabs for sputum. It must address three distinct implementation challenges: (1) building patient and provider trust in a non-sputum result; (2) defining clear decision pathways when results are positive at decentralized sites, including linkage to drug-resistance testing; and (3) ensuring quality assurance systems function outside laboratory settings.

To address the first point, research on acceptability, feasibility and usability of tongue-swab tests provide fresh insights.⁸ People affected by TB value rapidity, minimal invasiveness, and same-visit results; they also emphasize trust in sputum and the importance of accuracy. Providers prioritize tests that produce easy to understand results, and fit everyday workflows without excessive complexity.

Lessons from the rollout of Xpert MTB/RIF and other molecular tests can be leveraged to integrate nPOC-NAATs into referral pathways, result-reporting systems, digital infrastructure, and clinical decision-making.⁷ WHO has stressed the need for explicit national algorithms, careful planning of test integration, and attention to human resources, biosafety, and quality assurance when introducing new technologies.⁵

The value of nPOC-NAATs will be context-dependent: time to adoption, costs, feasibility, and yield will differ by TB burden, HIV prevalence, laboratory infrastructure, and health system structure. From experience, we know high-burden countries are slow to adopt new tools, and the critical path for regulatory approval and adoption by health ministries can be long. We now have detailed critical path information from nine countries in Africa and Asia that can help identify and overcome barriers for adoption.⁹

National TB programmes must prospectively define where nPOC-NAATs should be placed and for which populations, before deployment begins. Again, the Xpert rollout is instructive: stock-outs, maintenance delays and failures, and weak data systems recurrently undermined population-level efficiency even when devices performed well.^6,7

The lower device complexity of nPOC-NAATs reduces some of these risks, but supply chain fragility and result reporting from community sites remain real vulnerabilities. The fact that nPOC technologies are manufactured in the Global South may help mitigate some of these challenges. Economic evaluations must move beyond cost per test to encompass treatment initiation and mortality, and should model platform decentralization and non-sputum compatibility as separate contributors.¹⁰

Diagnostic innovations consistently risk exacerbating existing inequities. The features that make nPOC-NAATs innovative—portability, low per-test cost, and non-sputum compatibility—are precisely the features that could shift access toward the populations historically most excluded: people living with HIV, young children, the homeless and incarcerated, and rural communities far from referral laboratories. That shift will not happen by default. Passive rollout to accessible facilities will replicate existing patterns of unequal access at lower cost.

Equity-focused deployment requires prospective monitoring disaggregated by age, sex, HIV status, socio-economic status, and geography, with pre-specified adaptive strategies when gaps are detected. Acceptability of tongue swabs cannot be assumed and must be demonstrated in the communities where these tests will be used and provider and patient confidence in non-sputum results must be cultivated, not presumed.

The WHO recommendation on nPOC-NAATs is a welcome development. But it does not guarantee that more people with TB will be diagnosed and treated. Realizing nPOC-NAATs’ potential requires a focused agenda that is action-oriented:

• •Comparative effectiveness studies evaluating nPOC-NAATs at different health system levels, community, primary care, first-level laboratory, and in cascade completion and treatment initiation as primary outcomes.
• •Context-specific cost-effectiveness analyses that model decentralized placement and non-sputum compatibility as separate contributors, incorporate patient-borne costs, and use treatment completion rather than cost per case detected as the primary metric and include benefit assessment.
• •Prospective equity monitoring embedded in implementation projects, tracking who is reached disaggregated by age, sex, HIV status, economic status, and geography, with adaptive strategies triggered by detected gaps rather than programme review cycles.
• •Implementation science evaluating provider training requirements, quality assurance performance at decentralized sites, and trust-building strategies for non-sputum results, to define the minimum conditions under which nPOC-NAATs generate reliable population-level benefit.
• •Extra-pulmonary TB detection Whether tongue swabs can contribute to the diagnostic workup of extrapulmonary TB—particularly in the subset with concurrent pulmonary involvement—remains an open question. Prospective studies in this population are warranted.
• •Fast-follower nPOC technologies need to be evaluated rapidly, so that countries have a wider range of products to choose from, especially as future products may include the ability to perform rapid drug-resistance testing.

In summary, three distinct advances—lower cost, platform decentralization, and non-sputum sample compatibility—now converge in a novel, innovative class of tools with genuine potential to change who gets diagnosed with TB and where. We must ensure this potential is realized by encouraging rapid adoption, implementation, and large-scale delivery.

Thankfully, multiple countries have already begun rolling out nPOC testing. The Global Fund is working with 13 early adopter high TB burden countries across the Americas, Africa, and Asia, while the Stop TB Partnership's TB REACH Wave 11Plus is supporting 18 projects in 12 countries. In April 2026, the WHO, along with the Global Laboratory Initiative, published a nPOC and swab-based testing toolkit, which includes training slides, checklists, job aids, and standard operating procedures. Learnings from these country experiences and technological improvements should result in greater adoption and better patient outcomes.

Contributors

MP, CD: Conceived the paper.

CD, SY: Drafting the first version of the manuscript.

AC, MP: Expert input and critical revision of the manuscript.

All authors reviewed the final version.

Declaration of interests

CD, SY and AC have no financial investments or relationships with any product or company. CD, SY and AC have been, through R2D2 TB Network (NIH, U01AI152087 and R01AI190419), SMART4TB (US State Department, 7200AA20CA00005), R2D2 xTB and R2D2 HIVPlus (Gates Foundation INV-080721 and INV-081068), involved in clinical studies of novel TB diagnostic tests in development, including MiniDock MTB test. MP serves as an advisor to non-profits, namely the World Health Organization, Gates Foundation, and Partners in Health. He declares no financial or industry conflicts.