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Updated: Jul 23, 2025

A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
Updated Operational Guidance for Implementing CDC's Recommendations on Testing for Hepatitis C Virus Infection
Insights
Complete hepatitis C virus (HCV) testing requires performing an HCV RNA test when an antibody test is reactive. Single-visit sample collection ensures complete HCV testing and links more patients to curative treatment.
Area of Science:
- Hepatology and Viral Immunology
- Public Health and Infectious Disease Management
Background:
- Current hepatitis C virus (HCV) diagnostic guidelines recommend a two-step antibody-then-RNA testing sequence.
- Incomplete HCV testing, defined as a reactive antibody test without a subsequent RNA test, historically affects approximately one-third of patients.
- Incomplete testing hinders national efforts to eliminate HCV infection.
Purpose of the Study:
- To clarify and update guidance on HCV testing procedures to ensure complete diagnostic testing.
- To promote strategies that facilitate immediate HCV RNA testing upon reactive antibody results.
- To improve patient linkage to care and curative antiviral therapy for HCV infection.
Main Methods:
- Recommending all HCV screening sites implement single-visit sample collection protocols.
- Advocating for automatic HCV RNA testing on all HCV antibody-reactive samples.
- Discouraging testing strategies that necessitate multiple patient visits for sample collection.
Main Results:
- Single-visit sample collection enables automatic HCV RNA testing for antibody-reactive individuals.
- This approach is projected to significantly reduce instances of incomplete HCV testing.
- Increased complete testing is expected to improve the proportion of patients receiving timely diagnosis and treatment.
Conclusions:
- Implementing single-visit sample collection and automatic RNA testing is crucial for achieving national HCV elimination goals.
- This updated testing strategy ensures comprehensive HCV diagnosis.
- Streamlined testing pathways will enhance patient access to curative antiviral therapies.
Abstract:
Current hepatitis C virus (HCV) testing guidance recommends a two-step testing sequence for diagnosis of HCV infection. Performing an HCV RNA test whenever an HCV antibody test is reactive (complete testing) is critical to achieve national HCV elimination goals. When an HCV antibody test is reactive and no HCV RNA test is performed, testing is considered incomplete. Historically, approximately one third of patients have incomplete testing. This update clarifies that all sites performing HCV screening should ensure single-visit sample collection. This approach allows for automatic HCV RNA testing when an HCV antibody test is reactive to avoid incomplete testing. Use of strategies that require multiple visits to collect HCV testing samples should be discontinued. Automatic HCV RNA testing on all HCV antibody reactive samples will increase the percentage of patients with current HCV infection who are linked to care and receive curative antiviral therapy.
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