Updated Operational Guidance for Implementing CDC’s Recommendations on Testing for Hepatitis C Virus Infection

Methods

In October 2021, the Association of Public Health Laboratories convened a meeting with experts from public health laboratories, academic medical centers, commercial laboratories, public health agencies, and community-based organizations to discuss obstacles to HCV testing in the United States.† After the meeting, CDC reviewed the published literature to determine the magnitude of incomplete hepatitis C testing using the two-step testing sequence.

Review of the Evidence

The following studies conducted in a variety of settings found that use of operational strategy 1 resulted in a sizable proportion of persons having incomplete HCV testing. In addition, studies have found that complete testing rates improve when operational strategies 2–4 are implemented. For example, data from the Chronic Hepatitis Cohort Study found that only 62% of patients had complete HCV testing (6). Similarly, only 66% of HCV antibody reactive patients who reported to the New York City Department of Health and Mental Hygiene surveillance system had complete HCV testing; this prompted a requirement in 2015 that all laboratories perform automatic HCV RNA testing (operational strategies 2–4) (7). Among Veterans Health Administration (VA) facilities that required a separate visit for subsequent HCV RNA testing (operational strategy 1), only 64% of patients completed the HCV testing sequence, whereas 98% of veterans completed testing in facilities that used operational strategies 2–4 (8). Since 2018, VA directive 1300.01 has required that all specimens that are reactive for HCV antibody undergo automatic testing for HCV RNA. Similarly, the Cherokee Nation Health Services found that 68% of persons had complete HCV testing when using operational strategy 1, but after implementing automatic HCV RNA testing, the proportion with complete testing increased to 85% (2,9). The Mid-Atlantic Permanente Medical Group developed a multifaceted hepatitis C care pathway that included automatic HCV RNA testing and found that the diagnosis of current HCV infection was statistically significantly higher when using the hepatitis C care pathway compared with the historical approach that used operational strategy 1 (3). Operational strategy 1 has also been found to not be cost-effective (10).

Updated Operational Guidance

This update clarifies that operational strategy 1 should be discontinued; operational strategies 2, 3, or 4 should be used to diagnose current HCV infection. In settings where HCV antibody testing is performed using finger-stick blood (operational strategy 4), a separate sample should be collected at the same visit to ensure that HCV RNA testing is completed when the HCV antibody result is reactive. If an HCV antibody is reactive and no HCV RNA test is performed, testing is considered incomplete; an HCV RNA test should be performed for all HCV antibody reactive samples to establish the diagnosis of current HCV infection. Sites performing HCV screening should ensure single-visit sample collection (operational strategies 2–4) are used to avoid incomplete HCV testing.