New tools and policies herald a major advance in tuberculosis diagnosis

New testing class and new WHO policy

In February 2026, the WHO issued, for the first time, recommendations on new, affordable, near-point-of-care (NPOC) molecular tests for the diagnosis of TB, along with recommendations on easy-to-collect tongue swab samples to simplify and expand access to TB testing, and a new pooling strategy that can reduce test costs while reducing the time people wait for results.⁹

According to WHO, near point-of-care nucleic acid amplification tests (NPOC-NAATs) are molecular tests for TB detection with or without drug resistance that can produce results from a primary sputum or tongue swab sample in less than one hour using instruments that can be battery operated, do not require specialised infrastructure for use or storage, and can be done by testers without specialized laboratory skills at peripheral levels of the health system, much closer to where people live and work (i.e., communities and primary healthcare centres). However, like smear microscopy, this class of tests does not yet incorporate rifampicin-resistance detection and therefore requires reflex testing with a complementary solution (e.g., Xpert MTB/RIF Ultra, Truenat MTB Rif-Dx, cobas MTB-RIF/INH, FluoroType MTBDR, BD MAX MDR-TB) for drug-resistance determination.

The first WHO endorsed product (Figure) in this new NPOC-NAAT class is the MTB Nucleic Acid Test Card by Pluslife Biotech (Guangzhou, China). To test, a provided swab is swirled in sputa ten times or across the tongue for 30 seconds and inserted into a sample tube that is pre-filled with lysis buffer and beads. The tube is then rapidly mixed and heated on a ThermoLyse instrument, and once done, the solution from the tube is dropped into the MTB Nucleic Acid Test Card and run on the Pluslife MiniDock (Pluslife Biotech, Guangzhou, China) amplification device that produces a result in approximately 30 minutes. Although not WHO endorsed yet, more NPOC-NAATs are in development or under evaluation to inform WHO policy assessment. Among these is the UniAMP^® Mycobacterium Tuberculosis Nucleic Acid Test Card by Huwel Lifesciences in Hyderabad, India (Figure). Huwel is Pluslife’s exclusive licensed partner in India, operating under the UniAmp brand pursuant to Pluslife’s technology license. The Huwel UniAmp test is validated and approved by the Indian Council of Medical Research for use in India in advance of any WHO product assessments.¹⁰

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Figure.

Molecular tests manufactured in the Global South that can be used with sputum and tongue swab samples for the diagnosis of tuberculosis. Photograph (A) shows the Truenat MTB Ultima chip, with tongue swabs processed by the TrueLyse technology, and (B) followed by DNA amplification using the Truelab real-time quantitative microPCR analyser by Molbio Diagnostics, India. (C) Photograph shows the UniAMP® Mycobacterium Tuberculosis Nucleic Acid Test Card used on the UniAmp NAT device by Huwel Life Sciences, Hyderabad, India. (D) shows the MTB Nucleic Acid Test Card used on the Minidock device by Pluslife Biotech (Guangzhou, China). Currently, only the Pluslife and Molbio technologies have been assessed and recommended by the World Health Organization Source: reproduced with permission (Madhukar Pai, Molbio Diagnostics and R2D2 Network).

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In addition to NPOC-NAATs, tongue swabs are also recommended for use on low-complexity automated NAATs (LC-aNAATs); expanding access to non-sputum testing across the testing network. These tests can be used to detect TB in less than two hours by testers with basic laboratory skills and technology placed in decentralised laboratory settings. Tongue swab use is specifically recommended for the existing Xpert MTB/RIF Ultra test, and the new Truenat MTB Ultima test from Molbio in Goa, India. This new assay was developed and optimised for swab use, where tongue swabs are collected for 30 seconds, inserted into a tube pre-filled with solution and beads, lysed on the dedicated TrueLyse instrument, and then transferred with a provided pipettor to the MTB Ultima chip for testing on the Truelab amplification device (Figure).

The new WHO recommendations, based on systematic and objective reviews of diagnostic accuracy, cost and cost-effectiveness, and end user value evidence from multiple countries, highlight that adults and adolescents with signs and symptoms of pulmonary TB, or who screen positive for pulmonary TB should receive NPOC-NAAT- or LC-aNAAT-based initial diagnostic testing on respiratory samples rather than smear microscopy. When sputum cannot be obtained, tongue swabs should be used on NPOC-NAATs, and may be used on LC-aNAATs, as initial diagnostic tests for TB.⁹ This expands options for TB testing to individuals that are unable to produce sputum, and are often at increased risk of TB morbidity and mortality, for the first time, helping to ensure they are diagnosed early and placed on appropriate treatment.

In the new policy, WHO highlights that ‘sputum remains the preferred sample type and should be collected and tested whenever possible, given improved diagnostic accuracy over tongue swabs.’⁹ This is because NPOC-NAAT and LC-aNAATs detect TB in sputum with summary sensitivities that are approximately 10-19% higher than that of tongue swabs when assessed among a majority of individuals that could produce sputum.

Compared with smear microscopy, the WHO Guideline⁹ Development Group judged the use of NPOC-NAATs on sputum to be very accurate [summary sensitivity of 85.4% (95% CI: 82.2–88.1) and specificity of 97.6% (95% CI: 96.9–98.1)], and NPOC-NAATs on tongue swabs to be accurate [summary sensitivity of 76.4% (95% CI: 71.2–80.9) and summary specificity of 99.2% (95% CI: 98.7–99.5)]. The diagnostic accuracy of tongue swab testing on LC-aNAATs varied between Xpert MTB/RIF Ultra and Truenat MTB Ultima, with the swab-optimised MTB Ultima showing higher sensitivity in the assessed population than Xpert MTB/RIF Ultra (76.2% vs. 66.6%, respectively).

How affordable is the first-in-class NPOC-NAAT? Recently, the Stop TB Partnership’s Global Drug Facility (GDF) announced the inclusion of the Pluslife’s MTB Nucleic Acid Test Card, Thermolyse device, and Minidock devices in their diagnostics catalogue. The price is USD 3.60 per test, while the two devices (MiniDock and Thermolyse) are priced at USD155 and USD 180, respectively, with a one-year warranty included.¹¹ In the current era of funding and aid cuts, this level of affordability could allow countries to expand access with less budget.

Currently, the Global Fund is working with 13 early adopter high TB burden countries across the Americas, Africa, and Asia to work towards stepwise rollout of NPOC-NAATs in 2026 which can then feed into any larger investments under Grant Cycle 8 funding in 2027.¹² Early adoption plans are likely to introduce NPOC-NAATs as complementary to existing testing network investments and designs, such as expanding testing in hard-to-reach areas that can be linked to TB treatment services but lack routine access to more centralised TB laboratories.

Implications for India

India accounts for about one-quarter of the global TB burden and nearly one-third of TB deaths.⁷ India’s National TB Elimination Programme (NTEP) has received high levels of political support and domestic funding, and India has already invested in over 9000 NAAT sites covering all districts. India is committed to transitioning from microscopy to upfront NAAT testing and greatly increase case finding, under the Dual-phase Operational Strategy for Tuberculosis elimination (DOST).¹³

The new WHO policies on NPOC-NAATs and tongue swabs are exceedingly well poised to help India realise this ambition. The fact that Indian made NPOC and low-complexity molecular technologies are available and validated by the Indian Council of Medical Research bodes well for scale-up, supporting local availability or manufacturing of the testing commodities and reducing reliance on complex global supply chains and product importation processes.¹⁰ Greater affordability, ability to complement the existing tiered testing network with decentralised molecular testing options at primary health centres, and ability to test people even if they can’t provide sputum samples will enable India to greatly expand the number and type of people to be tested, take testing closer to people, increase case finding, and helping to realise the DOST strategy goal of TB elimination.

It is worth noting that that all molecular technologies are multi-disease platforms and can be used for diverse needs, not just tuberculosis. Tests for HIV, influenza A and B, RSV, COVID-19, HPV, hepatitis B and C, and sexually transmitted infections are already available for one-stop-shop options and consolidation of testing services that are better suited to provide comprehensive results for health management. These solutions could play a key role in helping India achieve its goals beyond ending tuberculosis, such as ending the HIV/AIDS epidemic as a public health threat by 2030 and ensuring access to many of the diagnostics listed in India’s National Essential Diagnostics List (NEDL).¹⁴

To support India and other high burden countries with adoption and scale-up of NPOC-NAATs, WHO will soon release the second edition of the WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis. The updated guidelines (due to be published) will be accompanied by an updated WHO operational handbook on tuberculosis, which will provide guidance on all technologies, sample types and strategies currently recommended, steps for introducing new TB diagnostics into a health programme and updated model algorithms for testing and clinical management. A WHO Toolkit for near point-of-care and swab-based tuberculosis testing will also be published that outlines key steps for implementation of these new tools and provides customisable planning, readiness assessment, testing, training, and monitoring and evaluation materials to facilitate programme uptake.

In conclusion, after many years of innovation, research and development, we now have affordable, portable molecular tools and easy to collect samples. We can now truly reach people and settings that we previously could not. We call on high burden countries to adopt these new interventions as complementary solutions to other WHO-recommended products and strategies for testing, toward ensuring universal access to WHO-recommended initial and drug resistance testing services. If we cannot find TB, we cannot treat TB. And if we cannot treat TB, we cannot end TB.