Diagnostic performance of a RHAM-based point-of-care test for <i>Mycobacterium tuberculosis</i>.

ABSTRACT: 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 Mycobacterium tuberculosis 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.

SUBMITTER: Chen X 

PROVIDER: S-EPMC12676282 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature