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Observational study assesses MiniDock MTB diagnostic accuracy against Xpert in Indonesian TB patientsNew TB test shows promise in Indonesia trial

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Key Takeaway
Consider MiniDock MTB as a specific diagnostic option for adult presumptive pulmonary TB in resource-limited settings.

This observational study assessed the diagnostic accuracy and agreement of MiniDock MTB on sputum swabs against Xpert MTB/RIF Ultra, liquid culture, and composite reference standards. The research included 671 eligible and included presumptive pulmonary TB cases aged over 28 days across 15 community health centres, a lung clinic, and a lung hospital in Bandung, Indonesia.

Key findings indicated that specificity ranged from 96.8% to 98.8%. Agreement between MiniDock MTB and Xpert, excluding trace positives, was 94.8% with a 95% CI of 92.6 - 96.3 and a Kappa of 0.84. Sensitivity against liquid culture in adults was 86.2% (95% CI 78.8 - 91.3), while sensitivity against composite reference standards in adults was 55.8% (95% CI 48.9 - 62.6). Positive percent agreement was 82.8% in adults (95% CI 75.1 - 88.4) but only 25% in children (95% CI 4.6 - 69.9).

The study observed reduced sensitivity with lower bacillary burden, with a p-value of 0.004. A limitation noted by the authors was that small numbers of positive results precluded estimation of performance in children. Adverse events, serious adverse events, discontinuations, and tolerability were not reported. Funding was provided by the Gates Foundation INV-059052.

A new diagnostic test for tuberculosis, called MiniDock MTB, was tested in Indonesia and showed good accuracy in adults. The study included 671 people with suspected TB at community health centers, a lung clinic, and a lung hospital in Bandung. Researchers compared the new test to Xpert MTB/RIF Ultra, liquid culture, and other reference standards.

In adults, MiniDock MTB correctly identified 86% of TB cases confirmed by liquid culture. However, when compared to a broader composite reference standard, sensitivity dropped to 56%. The test was highly specific, meaning it rarely gave false positives, with specificity ranging from 97% to 99%. Agreement with Xpert was 95%.

The test performed less well in children and in people with low amounts of TB bacteria. In children, positive agreement was only 25%, though this was based on very few cases. The study authors noted that small numbers of positive results in children limited their ability to draw firm conclusions.

This was an observational study, not a randomized trial, so results should be interpreted with caution. The test is not yet widely available, and more research is needed to understand its role in TB diagnosis. For now, it shows promise as a potential tool for adult TB detection, but it is not ready for routine use.

What this means for you:
MiniDock MTB may help diagnose TB in adults, but it is less accurate in children and low-burden cases.

Study Details

EvidenceLevel 5
PublishedApr 2026
View Original Abstract ↓
Background: Access to tuberculosis (TB) diagnostics remains limited in high-burden countries, partly due to centralised and complex testing. We evaluated MiniDock MTB, a low-complexity near point-of-care (nPOC) assay, in sputum for diagnostic accuracy and agreement with Xpert MTB/RIF Ultra (Xpert). Methods: From September 2024 to April 2025, presumptive pulmonary TB cases aged >28 days were consecutively enrolled at 15 community health centres, a lung clinic, and a lung hospital in Bandung, Indonesia. Sputum was tested with MiniDock MTB on sputum swab, Xpert, and liquid culture. We assessed diagnostic accuracy against microbiological and composite reference standards (CRS) and agreement with Xpert. Results: From 3051 individuals screened, 671 were eligible and included; 533 were adults (aged[≥]15 years), 138 were children. Overall, 126 were Xpert-positive and 132 culture-positive. In adults, MiniDock MTB sensitivity was 86.2% (110/116; 95% CI 78.8 - 91.3) and 55.8% (110/197; 95% CI 48.9 - 62.6) against liquid culture and CRS, respectively; small numbers of positive results precluded estimation in children. Specificity ranged from 96.8% to 98.8%. Overall agreement between MiniDock MTB and Xpert (excluding trace positive) was 94.8% (95% CI 92.6 - 96.3; K = 0.84). Positive percent agreement was 82.8% (95% CI 75.1 - 88.4) and 25% (95% CI 4.6 - 69.9) in adults and children, respectively, and reduced with lower bacillary burden (p = 0.004). Conclusions: Sensitivity of MiniDock MTB in sputum against liquid culture exceeded the WHO threshold for a sputum-based nPOC TB test in adults. There was high agreement with Xpert but reduced sensitivity in low-bacillary burden TB disease. Keywords: tuberculosis; diagnostic; MiniDock; sputum swab Funding: Gates Foundation INV-059052.
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