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Diagnostic performance of a RHAM-based point-of-care test for Mycobacterium tuberculosis.
Xiang Chen1,2, Vincenzo Lai2, Leonardo Antonio Sechi3
1Health Care Center, The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China.
Frontiers in Public Health
|December 8, 2025
Summary
A new point-of-care test (POCT) using RNase Hybridization-Assisted Amplification (RHAM) shows high specificity for diagnosing tuberculosis (TB) rapidly. This affordable and portable TB test is promising for resource-limited settings.
Area of Science:
- Medical Diagnostics
- Microbiology
- Public Health
Background:
- Tuberculosis (TB) diagnosis faces delays, especially in resource-limited settings and for extrapulmonary cases.
- Point-of-care tests (POCTs) are needed to meet WHO ASSURED criteria for rapid TB detection.
- Current diagnostic methods can be slow, require specialized infrastructure, or lack accessibility.
Purpose of the Study:
- To evaluate the diagnostic performance of a novel, affordable POCT utilizing RNase Hybridization-Assisted Amplification (RHAM) technology.
- To assess the sensitivity and specificity of the RHAM-based POCT for detecting Mycobacterium tuberculosis complex.
- To determine the feasibility of the RHAM-based POCT in terms of speed, cost, and usability in diverse settings.
Main Methods:
- Prospective laboratory-based evaluation of a novel RHAM-based POCT.
- Testing with various clinical specimens from suspected TB patients.
- Comparison of RHAM-POCT results against standard methods: PCR, microscopy, and culture.
Main Results:
- The RHAM-based POCT achieved 83.3% sensitivity and 100% specificity.
- All non-tuberculous mycobacteria samples were correctly identified as negative.
- The test demonstrated a rapid average turnaround time of 18 minutes with minimal infrastructure requirements.
Conclusions:
- The RHAM-based POCT is a rapid, user-friendly, and cost-effective tool for TB diagnosis.
- Its high specificity and portability make it suitable for field and resource-poor environments.
- Further large-scale studies are needed to confirm sensitivity, particularly in paucibacillary cases.
