N Engl J Med
Portable TB test delivers lab-level accuracy in minutes
Clinical takeaway: MiniDock MTB offers near–point-of-care TB detection with high sensitivity (≈86% sputum, ≈80% tongue swabs) and >97% specificity, performing comparably to Xpert Ultra while enabling noninvasive sampling and rapid results in under 30 minutes.
Delayed or missed tuberculosis diagnoses remain a major global gap; a fast, low-cost test that works without lab infrastructure could expand access to lifesaving care.
In a prospective, multicountry diagnostic study of 1380 patients with suspected pulmonary TB, the MiniDock MTB molecular assay demonstrated strong performance across diverse settings.
Among 226 culture-confirmed TB cases (16.4%), sensitivity reached 85.7% (95% confidence interval [CI], 80.4–90.0) using sputum swabs and 79.6% (95% CI, 73.8–84.7) with tongue swabs; specificity exceeded 97.5% for both sample types. Results with sputum were similar to Xpert MTB/RIF Ultra (difference −2.8 percentage points), but markedly outperformed smear microscopy by >24 percentage points.
Performance was strongest in patients with higher bacillary burden (e.g., 98.5% sensitivity in smear-positive disease) and declined in paucibacillary cases, including people with HIV and smear-negative TB. Tongue swabs offered a noninvasive alternative, with sensitivity up to 96.4% in smear-positive disease and specificity near 99.5%, though lower sensitivity in low-burden disease.
The portable device, designed for near-point-of-care use, produces results in 12 to 25 minutes and requires minimal training; usability scores were high (median 75/100), with most users rating the test as easy to perform. No adverse events were reported.
“MiniDock MTB…met WHO targets for diagnostic accuracy and usability,” the authors wrote, highlighting its potential to “expand access to molecular tuberculosis testing” in decentralized settings.
Cost (<$180 device; <$4/test) and flexibility for patients unable to produce sputum further support its potential role in replacing smear microscopy and improving TB detection globally.
Source: Yerlikaya S, et al; R2D2 TB Network and SMART4TB Consortia. (2026, April 29). N Engl J Med. Pulmonary Tuberculosis Detection with MiniDock MTB Using Swab Samples