Rapid HCV RNA Point-of-Care Test Delivers Results in 15 Minutes
Overview
A novel point-of-care test, the DASH® Rapid PCR Platform, provides qualitative hepatitis C virus (HCV) RNA results in just 15 minutes using capillary whole blood. This rapid turnaround time may enhance same-day diagnosis and treatment, addressing key barriers in HCV care pathways.
Background
Hepatitis C virus (HCV) elimination efforts are hindered by the complexity and delays of conventional laboratory-based RNA testing, which often require multiple visits and venous blood draws. Point-of-care HCV RNA testing can improve linkage to care by enabling diagnosis and treatment in a single visit, especially in settings such as harm reduction services and outreach programs. Existing tests like the Xpert® HCV VL Fingerstick reduce time to result but still require 40–60 minutes and have limitations in cost, portability, and usability.
Data Highlights
Parameter
Value
Dynamic range
256–4,000,000 IU/mL (R² = 0.98)
Limit of detection
200 IU/mL
HCV genotypes detected
1–6
Clinical validation specimens
77 HCV-detectable, 20 HCV-undetectable
Clinical validation accuracy
100% sensitivity and specificity
Specimen volume
100 µL plasma or whole blood
Time to result
15 minutes
Device dimensions (W×H×D)
10.9 cm × 29.5 cm × 38.4 cm
Device weight
4.4 kg (9.7 lb)
Key Findings
The DASH® Rapid PCR Platform provides qualitative HCV RNA results in 15 minutes from 100 µL of capillary whole blood or plasma.
Laboratory validation showed a dynamic range of 256 to 4,000,000 IU/mL and a limit of detection of 200 IU/mL across HCV genotypes 1–6.
Clinical validation demonstrated 100% sensitivity and specificity in detecting HCV RNA in 77 positive and 20 negative specimens.
The device uses solid-phase extraction with paramagnetic particles to isolate pure HCV RNA, overcoming challenges of nucleic acid extraction from whole blood at point of care.
The platform is compact and portable, weighing 4.4 kg, facilitating deployment in decentralized and resource-limited settings.
Further large-scale prospective studies using fresh capillary blood are needed to confirm real-world performance and feasibility.
Clinical Implications
The availability of a rapid, 15-minute HCV RNA point-of-care test could significantly improve patient retention by enabling diagnosis and treatment initiation within a single visit. This technology may enhance access to care in diverse settings, including harm reduction and outreach programs, thereby advancing progress toward WHO HCV elimination targets. Its portability and ease of use support broader implementation in resource-limited environments.
Conclusion
The DASH® Rapid PCR Platform represents a promising advancement in HCV diagnostics, offering rapid, accurate RNA detection at the point of care. With further validation, it has the potential to transform HCV testing and treatment paradigms by facilitating immediate clinical decision-making.
References
Reed et al. 2024 -- Diagnostic accuracy of the DASH® Rapid PCR Platform for HCV RNA
