In June 2024, the FDA authorized the Cepheid Xpert HCV test to detect hepatitis C virus (HCV) RNA, marking a significant milestone for the viral hepatitis community in the U.S. This first-ever HCV RNA point-of-care (POC) test runs on the GeneXpert Xpress system in CLIA-waived settings. It detects HCV RNA in adults aged 22 years and older via fingerstick, providing positive results in as little as 41 minutes, with negative results confirmed within 60 minutes.
For various settings and populations, HCV RNA POC testing may provide more prompt diagnosis and facilitate more rapid initiation of HCV treatment compared to the current standard-of-care. Settings capable of optimizing workflows and timely linkage to care, particularly those serving communities with higher prevalence of HCV and a greater likelihood of not receiving confirmatory testing following a positive antibody test, may find that integration of HCV RNA POC testing can improve patient access and outcomes. Informed decisions about adoption and implementation of HCV RNA POC testing necessitate consideration of multiple factors, including financing, treatment capacity, and logistics.
Here are some initial considerations to help you assess whether this test might be suitable for your organization:
- Initial Investment: Integration of HCV RNA POC testing requires up-front costs of acquiring the GeneXpert Xpress system and Xpert HCV cartridges. Before discounts, the 2-module system is $21,000 while the 4-module system is priced at $39,000. Settings with funding constraints may wish to explore whether alternative payment and financing models could be negotiated with the manufacturer.
- Turnaround Time: The potential value of HCV RNA POC testing relates to the test’s turnaround time, or the length of time needed for the test to provide a result (as early as 41 minutes for positive results, and up to 60 minutes for negative results). Settings may wish to consider how this timing fits within your workflow and the typical duration of contact or appointment for the population being tested.
- Throughput and Workflow: Throughput refers to the number of tests that can be run simultaneously (either 2 or 4, depending on the device). The benefit of HCV RNA POC testing over current standard-of-care (e.g., antibody-testing only, onsite phlebotomy, or referral to offsite lab) depends on whether results can be delivered immediately and whether strategies like incentives can help ensure that individuals receive their diagnosis.
- Infrastructure Requirements: The GeneXpert instrument requires a stable power supply and a temperature-controlled environment (59-86°F). Specimens remain stable for up to 4 hours at temperatures between 35.6 and 83°F. Outreach and mobile settings might consider the need for coolers and transporting specimens to the machine to maintain these conditions.
- Financing and Reimbursement: Reimbursement for the GeneXpert HCV test may vary depending on the insurance provider and setting in which testing is being provided. For example, Medicare’s current national coverage determination (NCD) for HCV screening is limited to primary care and has not been updated to align with CDC universal screening guidelines. Not all organizations may be eligible to bill insurance. It’s important to review coverage policies and explore funding options to ensure sustainability in both clinical and outreach settings.
- Data Management: Effective data management is essential for patient follow-up and reporting to health departments. The GeneXpert Xpress can integrate with electronic health records and laboratory information systems, though this may require additional IT infrastructure and support.
Ensuring equitable access to diagnosis for ALL people with hepatitis C can facilitate timely treatment initiation, but requires addressing several potential barriers:
- Guidelines and Protocols: Current AASLD/IDSA guidelines recommend pretreatment labs involving laboratory blood draws. Advancing the development and marketing of point-of-care assessments for hepatitis B virus and cirrhosis would help facilitate same-day treatment.
- Provider Accessibility: A prescribing provider needs to be available either on-site or via telehealth. Ensuring that such accessibility is reliably in place is crucial for timely treatment.
- Prior Authorization: Insurance companies often require prior authorization for hepatitis C medications, a process that can delay treatment by days or weeks. Efforts to expedite this authorization process or explore alternative solutions could improve the efficiency of same-day treatment.
- Onsite Treatment Availability: Insurance policies frequently mandate that hepatitis C medications be dispensed through specialty pharmacies, which commonly operate through mail order. Developing strategies to address this logistical challenge could facilitate more timely treatment initiation.
The Xpert HCV test may have particular impact in the following scenarios:
- High Prevalence, High Volume Settings: Your site serves a population with a high prevalence of hepatitis C and high volume of individuals, where early detection and intervention are crucial.
- Remote or Underserved Areas: Access to phlebotomy is limited, making POC testing a more viable option for timely diagnosis and treatment initiation.
- Supportive Infrastructure: Adequate infrastructure and support systems are in place to facilitate training, workflow integration, quality assurance, and data management associated with POC testing.
- Cost-Effectiveness: The benefits of HCV POC RNA testing in reducing incomplete diagnosis and shortening time from diagnosis to treatment initiation outweigh the associated costs, including training, equipment, and ongoing maintenance.
For the latest details on the test including its intended use, sample collection methods, stability, and storage requirements, visit: https://www.cepheid.com/en-US/tests/blood-virology-womens-health-sexual-health/xpert-hcv-info.html. Pricing information, tailored to different types of organizations, can also be requested through this link.
Do you have questions or insights you’d like to share with us about implementing hepatitis C RNA point-of-care tests? We’d love to hear from you! Join NVHR’s Viral Hepatitis Diagnostics Working Group.
Special thanks to NVHR’s Viral Hepatitis Diagnostics Working Group, whose knowledge and collective input were essential to the creation of this resource.
Last Updated: August 2024