Rapid Point-of-Care Hepatitis C RNA Test Using DASH PCR System
Overview
A novel rapid molecular test for hepatitis C virus (HCV) RNA was developed using the DASH Rapid PCR System, delivering results in 15 minutes. The test demonstrated 100% agreement with commercial platforms in a preliminary clinical validation and detects all major HCV genotypes with a limit of detection of 200 IU/mL.
Background
Hepatitis C virus infection remains a significant global health issue, with chronic infection leading to severe liver disease. Diagnosis typically requires a two-step process: antibody screening followed by molecular confirmation of active infection, which often delays treatment initiation. Point-of-care molecular testing can streamline diagnosis and improve linkage to care, especially in resource-limited settings. Currently available molecular POC tests, such as the GeneXpert system, require up to 60 minutes for results, limiting their utility in many clinical environments.
Data Highlights
Parameter
Value
Time to result
15 minutes
Limit of detection
200 IU/mL
Specimen volume
100 µL plasma
Genotypes detected
1–6
Positive percent agreement
100%
Negative percent agreement
100%
Clinical specimens tested
97 plasma samples
Key Findings
The DASH HCV assay provides qualitative detection of HCV RNA in 15 minutes, significantly faster than existing POC tests.
It detects all major HCV genotypes (1 through 6) with equivalent sensitivity.
The assay has a limit of detection of 200 IU/mL using 100 µL of plasma.
In a clinical validation with 97 plasma specimens, the DASH assay showed 100% positive and negative percent agreement compared to commercial molecular platforms.
The test is user-friendly, integrating sample preparation and amplification in a single automated system suitable for point-of-care use.
Clinical Implications
The DASH HCV test enables same-day molecular diagnosis of active HCV infection, facilitating immediate linkage to curative antiviral therapy. Its rapid turnaround and ease of use support deployment in diverse clinical settings, including resource-limited environments, potentially improving the HCV care cascade and advancing elimination efforts.
Conclusion
The DASH Rapid PCR System offers a highly sensitive, rapid, and user-friendly molecular test for HCV RNA detection at the point of care. This innovation may overcome current diagnostic barriers and accelerate timely treatment initiation for hepatitis C.
References
Johns Hopkins University Study -- Clinical Validation of DASH HCV Assay
World Health Organization 2022 -- HCV Treatment Guidelines
FIND Target Product Profile -- Optimal HCV POC Test Characteristics
Minute Molecular Diagnostics/Nuclein -- DASH Rapid PCR System Development
