2025-12-08 ノースウェスタン大学
HCV can lead to a chronic hepatitis C infection, which affects an estimated 50 million people globally and causes approximately 242,000 deaths annually, largely due to resulting cirrhosis and liver cancer. While the infection is curable with an 8- to 12-week course of medication, treatment rates remain low partially due to lack of affordable and easily accessible diagnostic tests. Getty Images
<関連情報>
- https://news.northwestern.edu/stories/2025/12/new-15-minute-hepatitis-c-test-paves-the-way-for-same-day-treatment
- https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaf608/8374811?searchresult=1
- https://www.mdpi.com/2075-4418/11/7/1253
DASH® Rapid PCR システムを用いた C 型肝炎ウイルス RNA の迅速自動ポイントオブケア検査の開発 Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH® Rapid PCR System
Jennifer L Reed,Matthew A Butzler,Claudia A Hawkins,Yukari C Manabe,Jeffrey Holden,David L Thomas,Andrea L Cox,Sally M McFall
The Journal of Infectious Diseases Published:10 December 2025
DOI:https://doi.org/10.1093/infdis/jiaf608
Abstract
Background
Hepatitis C virus (HCV) infection is a major public health problem despite the availability of highly effective and curative direct acting antiviral (DAA) treatments. Low diagnostic rates, driven in part by a two-step diagnostic process and the need for molecular confirmation, pose a significant barrier to timely treatment. Here we describe the development, analytical characterization, and a preliminary clinical validation study of a rapid, user-friendly, sensitive, qualitative molecular test for point-of-care HCV testing.
Methods
This study evaluated the analytical performance of a 15-minute time to result qualitative molecular test for HCV on the sample-to-answer point-of-care DASH® Rapid PCR System. The dynamic range, limit of detection, analytical specificity, and the equivalent detection of genotypes 1-6 were assessed. A small clinical validation study was independently conducted by Johns Hopkins investigators using retrospectively collected specimens.
Results
The Research Use Only (RUO) DASH® HCV assay has wide dynamic range, can detect HCV genotypes 1-6, and has a detection limit of 200 IU/mL with 100 μL specimen volume addition. In a preliminary study of 97 plasma specimens, the DASH® HCV assay demonstrated 100% positive percent agreement (PPA) and 100% negative percent agreement (NPA) when compared to commercial platforms.
Conclusions
The DASH® HCV test holds potential to enable same-day diagnosis and treatment in support of HCV elimination efforts.
C型肝炎の診断:簡素化された解決策、予測的な障壁、そして将来の展望 Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises
Imran Shahid,Abdullah R. Alzahrani,Saeed S. Al-Ghamdi,Ibrahim M. Alanazi,Sidra Rehman and Sajida Hassan
Diagnostics Published: 13 July 2021
DOI:https://doi.org/10.3390/diagnostics11071253
Abstract
The simplification of current hepatitis C diagnostic algorithms and the emergence of digital diagnostic devices will be very crucial to achieving the WHO’s set goals of hepatitis C diagnosis (i.e., 90%) by 2030. From the last decade, hepatitis C diagnosis has been revolutionized by the advent and approval of state-of-the-art HCV diagnostic platforms which have been efficiently implemented in high-risk HCV populations in developed nations as well as in some low-to-middle income countries (LMICs) to identify millions of undiagnosed hepatitis C-infected individuals. Point-of-care (POC) rapid diagnostic tests (RDTs; POC-RDTs), RNA reflex testing, hepatitis C self-test assays, and dried blood spot (DBS) sample analysis have been proven their diagnostic worth in real-world clinical experiences both at centralized and decentralized diagnostic settings, in mass hepatitis C screening campaigns, and hard-to-reach aboriginal hepatitis C populations in remote areas. The present review article overviews the significance of current and emerging hepatitis C diagnostic packages to subvert the public health care burden of this ‘silent epidemic’ worldwide. We also highlight the challenges that remain to be met about the affordability, accessibility, and health system-related barriers to overcome while modulating the hepatitis C care cascade to adopt a ‘test and treat’ strategy for every hepatitis C-affected individual. We also elaborate some key measures and strategies in terms of policy and progress to be part of hepatitis C care plans to effectively link diagnosis to care cascade for rapid treatment uptake and, consequently, hepatitis C cure.
