The WHO’s February 26 policy on TB recommends, for the first time, 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. Will this policy apply only for the initial detection of TB as it does not test for drug resistance? While the strategy seems to be about increasing the speed of initial detection, and taking this initial testing out of more complex labs, what would be the next steps?
The new WHO recommendation states, “in adults and adolescents with signs and symptoms of pulmonary TB or who screen positive for pulmonary TB, NPOC-NAATs on sputum should be used as initial diagnostic tests for TB rather than smear microscopy. When sputum cannot be obtained, NPOC-NAATs on tongue swabs should be used as initial diagnostic tests for TB.”
Currently approved NPOC tests can only detect TB. For drug-resistance testing, we still need other technologies such as Xpert MTB/RIF, or TrueNAT MTB/RIF, or liquid cultures.
Right now, many high TB burden countries are still too reliant on the century-old sputum smear microscopy. Affordable NPOC tests can help such countries replace smears with rapid molecular tests for initial TB detection.
How does this approach differ from current national TB control strategies? What have been the drawbacks and gaps in such strategies?
Existing molecular tools have largely been deployed at levels higher than primary care (e.g. district level facilities and centralised laboratories). And they have been expensive for low and middle-income countries, because technologies like Xpert MTB/RIF have had to be imported into high TB burden countries. Until recently, there have been no affordable, Global South manufactured products.
But today we have NPOC tests that are highly affordable and can be decentralized to primary care settings. And they can thus help expand testing to more people. And with tongue swabs, they can also be used to test people who are unable to produce sputum samples. Lastly, since these products are made in the Global South, we expect them to be more affordable, and better suited to low resource settings.
Why is the WHO switching from a sputum to a tongue swab test in its latest recommendation? What are the advantages?
To be clear, WHO is not switching from sputum to tongue swabs. Sputum is still the preferred sample for pulmonary TB. The new WHO policy states “when sputum cannot be obtained, NPOC-NAATs on tongue swabs should be used as initial diagnostic tests for TB.”
For decades, pulmonary TB detection has relied on patients providing sputum samples, and nearly a quarter of adults are simply unable to expectorate sputum samples. So, a big felt need in the TB community has been for a test that can be done without relying on sputum. Tongue swabs are easier to collect, and when combined with NPOC molecular technologies, offer a good option among people who are unable to provide sputum samples.
The WHO’s February 26 policy also recommends a sputum pooling strategy as a more cost-effective alternative. Explain how this diagnostic strategy works at the primary care level in resource-constrained countries like India with high TB burden.
Sputum pooling, in which samples from several individuals are mixed and tested together, is a strategy to improve testing efficiency and reduce costs in resource-constrained environments. In an ideal world, we won’t need to pool samples. We will test each sample separately. But given how expensive molecular tests like Xpert MTB/RIF have been, high TB burden countries have struggled to scale them up. To help with this resource constraint, the new WHO policy allows for pooling but states: “When resource constraints do not allow for the testing of individual samples, in adults and adolescents with signs and symptoms for pulmonary TB or who screen positive for pulmonary TB, low-complexity nucleic acid amplification tests on (up to 4) pooled sputa may be used as the initial diagnostic strategy for diagnosing TB rather than on individual samples.
I am hoping India can be more ambitious and make sure every individual sample is tested separately. The fact that India has greatly increased the domestic budget for TB, and there are several ICMR approved molecular tests manufactured in India makes me hopeful that India can make universal molecular testing a reality.
At the ground level, for countries like India, are NPOC tests available? And at what costs?
Examples of Global South made molecular tests that can be used with tongue swabs include the MTB Nucleic Acid Test Card used on the Minidock Ultra device by Pluslife Biotech (Guangzhou, China), the UniAMP® Mycobacterium Tuberculosis Nucleic Acid Test Card used on the UniAmp device by Huwel Lifesciences, Hyderabad, India, and the Truenat MTB Ultima chip, with tongue swabs processed by the TrueLyse technology, followed by DNA amplification using Truelab by Molbio Diagnostics, India. Currently, the Pluslife product is endorsed by WHO, listed via the Global Fund’s Expert Review Panel, and is classified as NPOC.
In India, Huwel is Pluslife’s exclusive licensed partner, 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.
Thanks to investments by various partners, Pluslife’s MTB Nucleic Acid Test Card used on the Minidock Ultra device is now available at $3.60 per test via the Global Drug Facility. This is about half the price of other WHO recommended rapid molecular tests. In the current era of funding cuts, this price point may allow countries to do more with less budgets.
How should governments/policy makers start operationalizing the WHO’s latest recommendations, incorporating them into national TB control strategies?
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.
To support India and other high burden countries with adoption and scale-up of NPOC-NAATs, WHO will soon release 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 soon.
I hope all high TB burden countries will adopt the new WHO policy and redouble their efforts to close the massive TB diagnostic gap. In particular, it is critical to make sure all people with TB symptoms get an upfront rapid molecular test that is WHO approved. That is now within the realm of the possible.
Key references
- Pai M, Dewan PK, Swaminathan S. Transforming tuberculosis diagnosis. Nat Microbiol 2023; 8(5): 756-9.
- World Health Organization. Near point-of-care tests, tongue swabs, and sputum pooling for TB. URL: https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/diagnosis-treatment/npoc-tongue-swabs-and-sputum-pooling-for-tb [date accessed 5 March 2026]. 2026.
- Indian Council of Medical Research. MTB/MDR-TB detection kits prospectively validated and approved by ICMR. URL: https://www.icmr.gov.in/icmrobject/uploads/Static/1751000654_listofapprovedkitsfortb.pdf [date accessed 9 March 2026]. 2025.
- Stop TB Partnership. An Early Present For 2026: Innovative Near-poc Pulslife TB Test Available In GDF Catalogue For $3.60. URL https://www.stoptb.org/news/early-present-2026-innovative-near-poc-pulslife-tb-test-available-gdf-catalogue-360 [date accessed 5 March 2026]. 2025.
- Gaeddert M, Papadopoulou P, Habbes J, et al. Sputum scarcity among adolescents and adults with presumptive tuberculosis: a systematic review and meta-analysis. medRxiv 2025. https://pubmed.ncbi.nlm.nih.gov/41282929/
VIVEKA ROYCHOWDHURY, Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com