Portable Molecular Test Matches Standard TB Diagnostics for accuracy: Study
A new research published in The New England Journal of Medicine developed a portable molecular testing system for Tuberculosis (TB), the MiniDock MTB that demonstrated high diagnostic accuracy in a prospective study, addressing gaps in regions with limited access to advanced testing.
This showed sensitivity/specificity comparable to the Xpert MTB/RIF Ultra and superior to sputum-smear microscopy, meeting World Health Organization targets for near point-of-care TB diagnostics.
Tuberculosis continues to be a major global health burden, with millions of cases going undiagnosed or unreported each year. Bridging the gap between estimated and confirmed cases has been a key priority for global health agencies like the WHO. Tools that can function effectively outside centralized laboratories are noticed as critical to this effort.
This large international study between September 2024 and March 2025, this research evaluated the performance of MiniDock MTB in real-world outpatient settings across India, Nigeria, the Philippines, South Africa, Uganda, Vietnam, and Zambia. The study enrolled 1,380 participants over 12 years and who showed symptoms of pulmonary TB, including individuals living with HIV who are vulnerable to the disease.
The MiniDock MTB test was evaluated using traditional sputum and less invasive tongue swabs. These results showed that the test achieved a sensitivity of 85.7% with sputum samples and 79.6% with tongue swabs. The test correctly identified the majority of TB cases where the specificity exceeded 97.5% for both methods, which indicated a low rate of false positives.
Also, the performance of this test was comparable to the widely used Xpert MTB/RIF Ultra assay. The sensitivity of MiniDock MTB was only slightly lower by 2.8 percentage points. However, it significantly outperformed traditional sputum-smear microscopy, which showed elevated sensitivity of over 24 percentage points with sputum and 18 percentage points with tongue swabs.
Beyond accuracy, the health care workers rated the device with a median score of 75 out of 100 on the system usability scale, which reflected good ease of use. Observations confirmed that the test could be administered effectively in decentralized settings without the need for highly specialized training or infrastructure. No adverse events related to the test were reported. Overall, these findings suggest that MiniDock MTB could play a crucial role in expanding access to reliable TB testing, particularly in rural or resource-limited areas.
Source:
S. Yerlikaya,. M. Chirwa,. B. Ajide,. M.M. Castro,. H. Ha,. M. Kato‑Maeda,. E. Kisakye,. D. Marcelo,. T. Mochizuki,. L. Rockman,. A. Steadman,. B. Thangakunam,. J.S. Bimba,. D.J. Christopher,. M. Muyoyeta,. H. Phan,. G. Theron,. C. Yu,. K. Kremer,. P.P.J. Phillips,. P. Nahid,. C.M. Denkinger,. A. Cattamanchi & A. Andama. Pulmonary tuberculosis detection with MiniDock MTB using swab samples. The New England Journal of Medicine. April 2026,. http://10.1056/NEJMoa2509761
