China Approves Third Tongue Swab-Based Molecular TB Test, Introducing POCT to Point-of-Care Diagnostics

For decades, diagnosing tuberculosis meant asking patients to cough up sputum—a simple requirement that becomes impossible for nearly 40% of suspected TB cases. Now, a quiet revolution in sample collection is reshaping how China tackles the world's fourth-largest tuberculosis epidemic.

On October 10, 2026, China's National Medical Products Administration approved the third tongue swab-based molecular test for Mycobacterium tuberculosis detection. This time, the breakthrough isn't just about the sample type—it's about bringing molecular diagnostics to the point of care.

Coyote Biotech's new Mycobacterium tuberculosis Complex Nucleic Acid Detection Kit, compatible with both tongue swabs and sputum samples, pairs with the company's single-test Flash Nano platform. The company calls it China's first molecular POCT system for TB detection using tongue swabs.

The Race for Better Adjectives

hugo biotech claimed the first tongue swab TB test on December 1, 2025. The TB-EASY® kit, registered under number 国械注准20253402448, was developed with a team from Beijing Chest Hospital, Capital Medical University, led by Pang Yu. Using dual IS6110 and IS1081 targets, the test demonstrated 89.6% sensitivity and 96.2% specificity compared to sputum Xpert testing.

Dian Diagnostics Group followed on August 30, 2026, unveiling its Jin Dian An® kit (registration 国械注准20263401611) at the 37th National Academic Conference of the Chinese Antituberculosis Association. The kit handles both tongue swabs and sputum with a single reagent set, also targeting IS6110 and IS1081. With a limit of detection of 1 CFU/mL, tongue swab testing showed 93.3% sensitivity and 96.8% specificity.

Now Coyote has entered the race, adding "molecular POCT" to the list of firsts. The company's multi-center prospective diagnostic accuracy study enrolled 687 suspected TB patients, collecting both sputum and tongue swab samples simultaneously. Against microbiological reference standards, sputum testing achieved 98.95% sensitivity and 98.69% specificity. Compared to industry benchmark rapid nucleic acid testing, tongue swab results reached 99.70% sensitivity and 98.32% specificity.

The first company stopped at "tongue swab." The second added "dual sputum sample." The third tacked on "molecular POCT." As one industry observer joked: add enough qualifiers, and everyone can be first.

From Afterthought to Opportunity

Two years ago, tongue swabs weren't taken seriously in China. The World Health Organization didn't include them in its recommendations until March 2026, when it finally endorsed tongue swabs paired with near-molecular testing for initial diagnosis—specifically for patients unable to produce sputum.

The WHO's own data wasn't impressive: tongue swabs with low-complexity automated nucleic acid amplification showed 76.4% sensitivity and 99.2% specificity, lower than sputum-based tests. It was a compromise—convenience traded for accuracy.

But the times are changing. Tuberculosis control now emphasizes prevention as much as treatment, and screening will eventually become routine. Tongue swabs are entering clinical practice with increasing frequency. Resistance to change, it turns out, fades with time.

In ten months, three companies have entered the market. The heat around tongue swab TB testing is undeniable.

The Numbers Behind the Need

China reported 569,000 tuberculosis cases in 2024, with an estimated 696,000 new cases—making it the fourth-largest TB burden globally. The WHO estimates 10.7 million new cases worldwide each year, with tuberculosis reclaiming its position as the leading cause of death from a single infectious disease.

According to Dian Diagnostics, roughly 40% of suspected TB patients cannot produce qualified sputum samples. That's the opening tongue swabs are designed to fill.

But screening products are essentially public health projects, paid for by governments. Convincing authorities to foot the bill requires cost-benefit calculations and regional screening data. The tuberculosis-free community initiatives launched in recent years have mostly operated as regional pilots, with screening data still limited in scale.

The tongue swab approval, for now, looks more like an entry ticket.

Fewer tickets mean more value. hugo biotech got the first one. Dian Diagnostics added dual samples. Coyote layered on molecular POCT. What qualifiers the next company will claim remains to be seen. But once dozens of manufacturers hold tongue swab registrations, market share won't be decided by adjectives.

Tongue swabs went from unwelcome to unavoidable, from afterthought to opportunity. That, perhaps, is IVD with Chinese characteristics.

Sources: National Medical Products Administration, hugo biotech, Dian Diagnostics Group, Coyote Biotech official websites and public reports (October 10, 2026)