CDC Experts Recommend Single-Visit Hepatitis C Antibody, RNA Testing

Credit: Unsplash / CDC

The Centers for Disease Control and Prevention (CDC) has provided new guidance recommending clinicians conduct RNA testing on all hepatitis C virus (HCV) antibody reactive samples to better streamline the rate of and efficiency in testing for the viral disease.¹

The updated recommendation, published Friday, goes against the current guidance advocating for a 2-step testing sequence in HCV infection diagnosis. Instances when no HCV RNA test is performed after an observed reactive HCV antibody test is considered incomplete—which historically, comprises approximately one-third of all hepatitis C tests.

“Performing an HCV RNA test whenever an HCV antibody test is reactive (complete testing) is critical to increase the percentage of patients diagnosed with current HCV infection who are linked to care and receive curative antiviral therapy,” the authors, led by Emily J. Cartwright, MD, of the division of viral hepatitis at the National Center for HIV, Viral Hepatitis, STD, and TB Prevention at the CDC, wrote in the new recommendation.

The CDC authors noted numerous laboratories have already implemented “automatic” HCV RNA testing protocol regardless of HCV antibody test results. In their update to institution’s 2013 recommendation, the authors wrote the following operational strategies should be followed to diagnose a current HCV infextion.

• From a single venipuncture, 2 specimens are collected in separate tubes—one tube for initial HCV antibody testing, and a second tube for HCV RNA testing if the HCV antibody test is reactive.
• The same sample of venipuncture blood used for initial HCV antibody testing is reflexed for HCV RNA testing without another blood draw, if reactive.
• A separate blood sample is submitted for HCV RNA testing if the initial testing of HCV antibody has used finger-stick blood.

The update negates their prior recommendation that blood from subsequent venipunctures are submitted for HCV RNA testing if reactive for HCV antibody. As such, their 3 remaining strategy recommendations allow for single-visit sample collections for patients and clinicians, “which ensures that HCV RNA testing is performed automatically without requiring a separate health care visit.”

A series of supporting clinical analyses supported the testing recommendation update, including an assessment of Veterans Health Administration (VA) facilities that showed approximately two-thirds (64%) of patients completed HCV testing sequences following their antibody reactive test at facilities that required a second visit to conduct HCV RNA testing. Conversely, 98% of patients who were tested at VA facilities that completed both antibody reactive and RNA testing at the same visit completed the HCV testing sequence.²

“Complete and accurate testing is the first step in identifying persons with current HCV infection to ensure linkage to care and initiation of curative antiviral therapy,” the authors wrote. “Using a single visit to conduct both steps of the HCV testing sequence will increase complete diagnosis of current HCV infection, which will increase the percentage of patients with current HCV infection who are linked to care and receive curative antiviral therapy.”

References

1. ^{Cartwright EJ, Patel P, Kamili S, Wester C. Updated Operational Guidance for Implementing CDC’s Recommendations on Testing for Hepatitis C Virus Infection. MMWR Morb Mortal Wkly Rep 2023;72:766–768. DOI: http://dx.doi.org/10.15585/mmwr.mm7228a2}
2. ^{Rongey CA, Kanwal F, Hoang T, Gifford AL, Asch SM. Viral RNA testing in hepatitis C antibody-positive veterans. Am J Prev Med 2009;36:235–8. https://doi.org/10.1016/j.amepre.2008.10.013}