Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH Rapid Polymerase Chain Reaction System - Summary - MDSpire

Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH Rapid Polymerase Chain Reaction System

  • By

  • Jennifer L Reed

  • Matthew A Butzler

  • Claudia A Hawkins

  • Yukari C Manabe

  • Jeffrey Holden

  • David L Thomas

  • Andrea L Cox

  • Sally M McFall

  • December 10, 2025

  • 0 min

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Objective:

To develop a rapid, user-friendly, sensitive, qualitative molecular test for point-of-care HCV testing.

Key Findings:
  • The DASH HCV assay demonstrated a detection limit of 200 IU/mL with 100 μL specimen volume.
  • Achieved 100% positive and negative percent agreement in clinical validation compared to commercial tests.
  • The assay can detect HCV genotypes 1–6.
Interpretation:

The DASH HCV test has the potential to facilitate same-day diagnosis and treatment, addressing barriers in HCV care.

Limitations:
  • The study was based on a small sample size of 97 specimens.
  • The DASH HCV assay is currently classified as Research Use Only (RUO).
Conclusion:

The DASH HCV test represents a significant advancement in rapid HCV diagnostics, supporting efforts for HCV elimination.

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