Clinical Scorecard: Creation of a Quick Automated Point-of-Care Test for Hepatitis C Viral RNA Utilizing the DASH Rapid PCR System
At a Glance
Category
Detail
Condition
Hepatitis C virus (HCV) infection
Key Mechanisms
Rapid, qualitative molecular detection of HCV RNA using sample-to-answer point-of-care PCR
Target Population
Individuals suspected of HCV infection, including those in resource-limited settings
Care Setting
Point-of-care settings including peripheral health or community-based facilities
Key Highlights
DASH HCV assay provides a 15-minute time to result for qualitative HCV RNA detection.
The assay detects HCV genotypes 1–6 with a limit of detection of 200 IU/mL using 100 µL specimen volume.
Preliminary clinical validation showed 100% positive and negative percent agreement compared to commercial platforms.
Guideline-Based Recommendations
Diagnosis
HCV diagnosis requires a 2-step process: anti-HCV antibody detection followed by HCV RNA confirmation.
Point-of-care molecular testing for HCV RNA is essential to improve timely diagnosis and linkage to treatment.
WHO recommends co-delivery of HCV POC testing and treatment at peripheral or community-based facilities.
Management
HCV infection is curable with an 8- to 12-week course of direct-acting antiviral therapy.
Same-day diagnosis and treatment facilitated by rapid POC testing can improve care cascade and outcomes.
Monitoring & Follow-up
Molecular confirmation of active infection is necessary to differentiate chronic from resolved infection.
Rapid POC testing can reduce delays and loss to follow-up in the diagnostic and treatment cascade.
Risks
Delays in molecular confirmation can lead to poor linkage to curative treatment and patient confusion.
Resource-limited settings face barriers due to expensive molecular tests and reagent availability.
Patient & Prescribing Data
Patients with suspected or confirmed HCV infection requiring molecular confirmation
Rapid POC molecular testing enables timely initiation of direct-acting antiviral therapy by confirming active infection within a single clinical encounter.
Clinical Best Practices
Implement rapid molecular POC testing to provide same-day HCV diagnosis and treatment initiation.
Use assays with analytical sensitivity of at least 200 IU/mL and capability to detect all major HCV genotypes.
Integrate testing and treatment services at the same site to improve linkage to care and reduce loss to follow-up.
