Diagnostic performance of a RHAM-based point-of-care test for Mycobacterium tuberculosis

Tuberculosis (TB) remains a global health crisis, hampered by significant diagnostic delays, particularly for extrapulmonary TB and in resource-limited settings. The development of point-of-care tests (POCTs) meeting the WHO's ASSURED criteria is crucial. This prospective laboratory-based study evaluated the diagnostic performance of a novel, affordable POCT based on RNase Hybridization-Assisted Amplification (RHAM) technology for detecting <i>Mycobacterium tuberculosis</i> complex. The test was evaluated using a variety of clinical specimens collected consecutively from suspected TB patients, compared against standard methods (PCR, Microscopy, culture). The RHAM-based POCT demonstrated promising sensitivity of 83.3% (10/12; 95% CI: 50.9-97.1%) and a specificity of 100% (25/25; 95% CI: 83.4-100%). All five non-tuberculous mycobacteria samples were correctly identified as negative. The two false-negative results occurred in samples with very high PCR cycle threshold values (>36), suggesting detection challenges in paucibacillary specimens. The test exhibited a rapid average turnaround time of 18 min and requires minimal infrastructure, operating via a portable, low-power consumption device, even compatible with mobile phone or car chargers. Its closed-cartridge system enhances biosafety by minimizing aerosol generation. Furthermore, the estimated cost per test is substantially lower than leading commercial molecular assays. This study indicates that the RHAM-based POCT is a rapid, user-friendly, and cost-effective diagnostic tool with high specificity. Its ability to function with diverse specimen types positions it as a potential game-changer for TB diagnosis in field and resource-poor environments, though larger-scale studies are warranted to confirm sensitivity, especially in low-bacterial-load scenarios.