Near-point-of-care molecular test accurately detects pulmonary tuberculosis

1. In patients with presumptive pulmonary tuberculosis, the MiniDock MTB molecular test using sputum and tongue swabs showed diagnostic accuracy consistent with World Health Organization targets for near-point-of-care tuberculosis testing. 

2. Sputum-swab MiniDock MTB had sensitivity similar to polymerase-chain-reaction assays, and both sputum- and tongue-swab testing were more sensitive than sputum-smear microscopy, with good usability and no test-related adverse events. 

Evidence Rating Level: 2 (Good)

Study Rundown: Tuberculosis remains a leading infectious cause of death worldwide, but access to rapid molecular testing is still limited in many high-burden settings. Sputum-based diagnostics can also be difficult to deploy in peripheral clinics and may be limited by patients’ inability to produce sputum. MiniDock MTB is a portable, low-cost molecular platform designed to test both sputum swabs and tongue swabs near the point of care. Prior work with prototype versions suggested promising diagnostic performance, but the accuracy and usability of the finalized clinical-use version were not yet clear. Hence, this cross-sectional diagnostic accuracy study evaluated MiniDock MTB in adolescents and adults with presumptive pulmonary tuberculosis across seven countries. Overall, MiniDock MTB showed strong performance with both sputum and tongue swabs, with sputum results closely approximating those of polymerase-chain-reaction assay and both sample types outperforming sputum-smear microscopy. Usability testing also suggested that the assay could be deployed with minimal training, and no adverse events related to the index test were reported. The generalizability of these findings is strengthened by the multicountry design, though interpretation is limited by the use under research settings, an imperfect microbiologic reference standard, and reduced precision in some subgroups, particularly those with lower bacillary burden. Nonetheless, this study suggests that molecular tuberculosis testing was reliable and could help expand testing access in decentralized settings, especially where nonsputum sampling is advantageous. 

Click to read the study in NEJM

Relevant Reading: Diagnostic accuracy of swab-based molecular tests for tuberculosis using near-point-of-care platforms: a multi-country evaluation.

In-Depth [cross-sectional study]: This cross-sectional diagnostic accuracy study enrolled 1380 participants 12 years of age or older with presumptive pulmonary tuberculosis at outpatient centers in India, Nigeria, the Philippines, South Africa, Uganda, Vietnam, and Zambia. Median age was 41 years, 43.7% of participants were female, 18.5% had human immunodeficiency virus infection, and 16.4% had culture-confirmed tuberculosis. MiniDock MTB was performed on both sputum swabs and tongue swabs and compared against a sputum liquid-culture microbiologic reference standard, sputum-smear microscopy, and polymerase-chain-reaction sputum Xpert MTB/RIF Ultra. With sputum swabs, MiniDock MTB had sensitivity of 85.7% and specificity of 97.6%. With tongue swabs, sensitivity was 79.6% and specificity was 99.5%. Sputum MiniDock MTB had sensitivity similar to sputum Xpert MTB/RIF Ultra (difference, -2.8 percentage points; 95% confidence interval [CI], -6.0 to 0.5), and greater sensitivity than sputum-smear microscopy (difference, 24.3 percentage points; 95% CI, 17.9 to 30.7). Tongue-swab MiniDock MTB also outperformed sputum-smear microscopy (difference, 18.3 percentage points; 95% CI, 12.0 to 24.7), though it remained less sensitive than sputum Xpert MTB/RIF Ultra. In a separate usability assessment, 18 health care workers in India and South Africa, none of whom had previously used the test, reported a median system usability score of 75, and 17 of 18 rated the test as acceptable. No adverse events related to MiniDock MTB were reported. Overall, these findings support MiniDock MTB as a feasible near-point-of-care molecular diagnostic option for pulmonary tuberculosis in high-burden settings.

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