Clinical Evaluation of Pluslife MiniDock MTB Test Published in eBioMedicine

A new multi-country study in The Lancet eBioMedicine reports a clinical evaluation of Pluslife MiniDock MTB Test. It shows that swab-based results meet near point-of-care TPP targets and outperform smear, and in paired comparison, sputum-swab sensitivity is within ~3.0 percentage points of sputum Xpert Ultra.

We are excited that the Pluslife MiniDock platform can bring high-accuracy near point-of-care TB testing closer to patients in decentralized settings. We will continue rigorous validation and programmatic collaboration to expand responsible access.

As mentioned in the paper:

Tongue swab testing: 85.7% sensitivity (95% CI: 75.3, 92.9) and 100% specificity, meeting WHO Target Product Profile (TPP) requirements for non-sputum, near point-of-care TB diagnostics.

Sputum swab testing: 91.1% sensitivity (95% CI: 82.1, 95.9) and >98% specificity, only 3.0% different from sputum Xpert MTB/RIF Ultra in paired comparison.

Test reliability: MiniDock MTB demonstrated excellent operational stability with low invalid result rates, 0.3% for tongue swabs and 0.6% for sputum swabs. All repeated tests returned valid results, confirming the assay’s consistency in real-world use.

With rapid results (<30 min) and a portable, low-cost design, MiniDock enables accessible, accurate molecular TB testing beyond traditional laboratories.

Reference
Steadman A. et al., eBioMedicine 2025;121:105991. DOI: 10.1016/j.ebiom.2025.105991
Full text: Here

Acknowledgments
Appreciation to the R2D2 TB Network and the study teams in India, Uganda, and Vietnam, and to all participants.