A multinational study recently published in The New England Journal of Medicine found that a portable molecular diagnostic device can detect pulmonary TB with high accuracy using both sputum and noninvasive tongue swab samples.1 This advance could expand access to TB testing in resource-limited settings.
In a multinational analysis of 1,380 patients with presumptive TB across outpatient clinics in seven high-burden countries, including India, Nigeria, South Africa, and Vietnam, the MiniDock MTB device demonstrated a sensitivity of 85.7% for sputum and 79.6% for tongue swabs, with specificity exceeding 97.5% for both sample types.
Seda Yerlikaya, PhD, of the Department of Infectious Diseases and Tropical Medicine at Heidelberg University Hospital, Germany, and colleagues reported that the results meet World Health Organization (WHO) target product profile thresholds for near-point-of-care TB diagnostics.
“The fact that these simple platforms are portable and battery-operated is an incredible development, bringing TB diagnostics to peripheral laboratories, closer to the communities,” said Alfred A. Lardizabal, MD, Executive Director of the Global Tuberculosis Institute at Rutgers New Jersey Medical School. “These are the reasons the WHO has a strong recommendation to support the use of these new tests to diagnose TB. This is the most major development since the WHO recommended the Xpert test as a replacement for the acid-fast bacillus smear for the diagnosis of TB in 2010, empowering communities by bringing the capacity to diagnose TB closer to them.”
According to the study, the MiniDock MTB achieved sensitivity comparable to that of the Xpert MTB/RIF assay in sputum testing and significantly higher sensitivity than smear microscopy.
The platform’s design—portable, battery-operated, and capable of producing results within 12 to 25 minutes—may enable testing in settings without advanced laboratory infrastructure. In addition, usability testing showed that health care workers could perform the test with only minimal training.1
“These diagnostic platforms are simpler and portable, making them a lot more usable in communities without requiring significant resource allocation and stable electricity supply,” Dr. Lardizabal said.
According to the data, the MiniDock MTB has a sensitivity of 79.6% and a specificity of 99.5% for tongue swabs, suggesting the approach could expand testing to the estimated 11% to 43% of patients who are unable to expectorate sputum.1
The study found reduced sensitivity in patients with lower bacillary burden, including those with smear-negative TB and individuals living with HIV. The authors noted that this pattern is consistent with prior evaluations of molecular diagnostics and reflects ongoing challenges in diagnosing paucibacillary disease. They suggested that further studies are needed to assess performance in these populations and evaluate real-world outcomes such as diagnostic yield and clinical impact.
“Having more TB testing options [may possibly] increase the diagnostic yield, for instance, in pediatric patients and patients who are HIV-positive, populations that have traditionally had lower diagnostic yield with sputum testing,” Dr. Lardizabal said. “The addition of tongue swabs to the armamentarium has the potential of confirming the diagnosis of TB.” Using the portable molecular diagnostic device to detect pulmonary TB aligns with the WHO recommendation to provide equitable, timely access to high-quality TB diagnostics at all health system levels.
References
1. Yerlikaya S, Chirwa M, Ajide B, et al. Pulmonary tuberculosis detection with MiniDock MTB using swab samples. N Engl J Med. 2026;394(17):1710-1722. doi:10.1056/NEJMoa2509761
