To develop and validate a rapid, automated point-of-care molecular test for detecting hepatitis C virus (HCV) RNA.
Key Findings:
The DASH® HCV test provides rapid results in about 15 minutes.
It has a detection limit of 200 IU/mL and can detect HCV genotypes 1 through 6.
The test showed 100% positive and negative agreement with established RNA assays.
Interpretation:
Rapid molecular POC testing could streamline HCV diagnosis, enabling confirmation of active infection during a single visit, particularly in settings with limited access to centralized labs.
Limitations:
The assay's analytical sensitivity is lower than high-throughput laboratory tests.
Further studies are needed to evaluate operational performance in real-world settings.
Conclusion:
The DASH® HCV test has the potential to improve HCV diagnosis and reduce patient loss to follow-up, but its use may be limited for treatment monitoring.
