A study published in The Journal of Infectious Diseases describes the development and early validation of a rapid, automated point-of-care (POC) molecular test for detecting hepatitis C virus (HCV) RNA using the DASH® Rapid PCR System. The assay is intended to address delays commonly seen between HCV screening and confirmation of active infection.
HCV diagnosis typically involves an initial antibody test, followed by laboratory-based RNA testing to confirm ongoing infection. While antibody screening is widely available at the POC, RNA testing usually requires centralized laboratories, which can introduce delays and increase the risk of patient loss to follow-up. The study evaluates whether a rapid molecular POC assay could help streamline this diagnostic pathway.
The DASH® HCV test is a qualitative, sample-to-answer RT-qPCR assay that delivers results in approximately 15 minutes. The system integrates RNA extraction, amplification, and detection into a single-use cartridge, minimizing hands-on time and reducing contamination risk. The assay was designed to meet key criteria for POC testing, including short turnaround time, minimal operator training, and clinically relevant analytical sensitivity.
Analytical studies showed that the assay has a detection limit of 200 IU/mL using a 100 µL sample volume, and is capable of detecting HCV genotypes 1 through 6 by targeting a conserved viral region. Specificity testing demonstrated no cross-reactivity with other bloodborne pathogens, including HIV, hepatitis B virus, and dengue virus.
Clinical performance was assessed using 97 retrospectively collected plasma samples tested at Johns Hopkins University. These included 77 HCV-positive and 20 HCV-negative specimens, covering a wide range of viral loads and genotypes. When compared with established laboratory-based RNA assays, the DASH® HCV test showed 100 percent positive and 100 percent negative percent agreement. Additional experiments indicated similar performance when testing contrived whole blood samples.
The study suggests that rapid molecular POC testing could enable confirmation of active HCV infection during a single clinical visit. This may be particularly relevant in community clinics, outreach programs, and other settings where access to centralized laboratories is limited. Faster confirmation may also support earlier clinical decision-making and reduce attrition between screening and diagnosis.
The authors note that the assay’s analytical sensitivity is lower than that of high-throughput laboratory viral load tests, which may limit its use for applications such as treatment monitoring or test-of-cure. Further studies in real-world POC settings will be needed to assess operational performance.
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