Clinical Scorecard: Rapid Hepatitis C Virus RNA Testing at the Point of Care Achieves 15-Minute Results

At a Glance

Key Highlights

• Conventional HCV diagnosis requires multiple visits and laboratory-based RNA testing, causing delays and loss to follow-up.
• The DASH® Rapid PCR Platform provides a qualitative HCV RNA result in 15 minutes using capillary whole blood, facilitating same-day diagnosis and treatment.
• The DASH® assay demonstrates high analytical specificity and sensitivity across HCV genotypes 1–6 with a limit of detection of 200 IU/mL.

Guideline-Based Recommendations

Diagnosis

• Integrate point-of-care HCV RNA testing to reduce time to diagnosis and improve linkage to care.
• Use capillary whole blood samples for rapid testing to enhance acceptability and feasibility in decentralized settings.

Management

• Implement test-and-treat strategies enabled by rapid RNA results to increase treatment uptake and reduce loss to follow-up.

Monitoring & Follow-up

• Further large-scale prospective studies are needed to validate real-world performance of rapid point-of-care HCV RNA assays.

Risks

• Be aware of technical challenges in nucleic acid extraction from whole blood that may affect test accuracy.
• Consider cost, portability, and usability factors when deploying point-of-care RNA tests in various settings.

Patient & Prescribing Data

Individuals at risk of or living with HCV infection requiring rapid diagnosis and treatment initiation

Rapid RNA testing reduces time to treatment and increases treatment uptake by enabling same-visit diagnosis and care linkage.

Clinical Best Practices

• Utilize rapid HCV RNA point-of-care tests to minimize patient loss to follow-up and improve treatment initiation rates.
• Deploy testing platforms with short turnaround times (under 20 minutes) to enhance patient acceptability and clinical workflow.
• Ensure testing platforms meet regulatory approvals (e.g., FDA 510(k) clearance) and usability standards for decentralized care.
• Conduct ongoing evaluation of test performance, operator preferences, and feasibility in diverse clinical settings.

References

• World Health Organization HCV elimination goals
• Xpert® HCV VL Fingerstick test evaluation
• DASH® Rapid PCR Platform FDA clearance 2024
• Reed et al. DASH® HCV assay diagnostic accuracy study