A fast, low-cost device detected TB from sputum and tongue swabs with high accuracy, raising hopes for easier diagnosis in communities where laboratory access remains a major barrier.
Study: Pulmonary Tuberculosis Detection with MiniDock MTB Using Swab Samples. Image Credit: Media Lens King / Shutterstock.com
In a recent prospective study published in The New England Journal of Medicine, researchers discuss the accuracy and usability of the MiniDock MTB. This portable device accurately diagnoses pulmonary tuberculosis across diverse, high-burden settings.
The hidden burden of undiagnosed TB
Tuberculosis (TB) remains a leading cause of infectious disease-related mortality worldwide, claiming over one million deaths every year. Current estimates suggest that 25% of adults and 50% of children, which equates to about three million people globally, are unknowingly infected with TB, further contributing to widespread transmission of this highly infectious disease.
Despite recent progress, there remains a lack of rapid, accurate tools for near-point-of-care use, which exacerbates these issues. Conventional diagnostic methods often require specialized laboratory equipment, trained personnel, and prolonged processing times, all of which delay timely diagnosis and treatment.
A portable TB test designed for low-resource settings
To mitigate these challenges, Guangzhou Pluslife Biotech has developed the MiniDock MTB, a molecular diagnostic test that, when combined with the transportable, battery-operated MiniDock PM001 Ultra testing device, can detect Mycobacterium tuberculosis complex. This low-cost platform relies on RNase-hybridization-assisted amplification technology that targets conserved regions of the IS6110 insertion sequence and the gyrB gene.
In the current cross-sectional study, researchers assessed the diagnostic performance and applicability of the final clinical version of MiniDock MTB across seven high-burden countries, including Nigeria, India, South Africa, the Philippines, Vietnam, Zambia, and Uganda. All study participants were 12 years of age and older with a presumptive history of pulmonary TB between September 2024 and March 2025.
Eligibility included a persistent or worsening cough for at least 14 days, as well as the presence of risk factors like abnormal chest radiographs or elevated C-reactive protein (CRP) levels among people with human immunodeficiency virus (HIV) infections. Sputum and tongue swab samples were collected for MiniDock MTB testing, along with blood samples for HIV and diabetes screening.
The diagnostic performance of MiniDock MTB testing was evaluated against a reference standard. Test results were compared with smear microscopy and polymerase chain reaction (PCR)-based data using Xpert MTB/RIF Ultra.
Usability was assessed on a 0-100 scale, with direct observation during simulated-use sessions at healthcare facilities in India and South Africa. Clinicians, nurses, and laboratory personnel involved in routine TB care participated in these assessments.
MiniDock MTB delivers fast and accurate TB detection
Among 1,380 enrolled participants, 44% of whom were female with a median age of 41 years, 19% were living with HIV, 16% were diagnosed with culture-verified TB, and 14% had diabetes. TB prevalence varied widely across sites, from 4.8% in India to 28% in Nigeria, with higher bacterial loads observed in African sites as compared to Asia.
The MiniDock MTB test showed 86% and 80% sensitivity for sputum and tongue samples, respectively, with a similarly high specificity of approximately 98% for both sample types.
MiniDock MTB outperformed smear microscopy by 24 percentage points for sputum and 18 points for tongue swabs, aligning with the accuracy benchmarks set by the World Health Organization (WHO) for decentralized TB testing. Sensitivity was higher among smear-positive cases, whereas slightly lower sensitivity correlated with samples obtained from females and individuals with HIV, a pattern consistent with known diagnostic challenges in paucibacillary disease.
Combining sputum and tongue swab samples further improved sensitivity to 88% and specificity to 97%. Repeat testing did not provide any additional advantages in assay performance, with no reported adverse events.
The median system usability score was 75, with 94% of healthcare workers describing the test as acceptable. Specifically, users reported that the test was easy to operate and appropriate in resource-limited settings, even with limited training, given its compatibility with non-invasive sampling.
Conclusions
MiniDock MTB is a low-cost, portable TB diagnostic tool that delivers highly accurate results in 12-25 minutes. Compared with conventional molecular assays, MiniDock MTB enables decentralized testing with minimal training, expanding access to timely diagnosis.
The exceptional performance of MiniDock MTB supports ongoing efforts to accelerate the deployment of rapid molecular testing under the End TB Strategy. Nevertheless, additional research is needed to evaluate real-world implementation and integration with drug-resistance testing.
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