Laboratory Recommendations for HCV testing

If a person has a reactive test for Hepatitis C Virus (HCV) antibody, a nucleic acid testing (NAT) for detection of HCV RNA should be run to determine if the patient has an acute infection of Hepatitis C and to determine treatment needs. The Hepatitis C antibody test does not distinguish between acute and past infection.

Unfortunately, investigation into the reported cases of Hepatitis C in the United States reveals a significant number of persons who have a reactive HCV antibody test, but do not have follow-up with HCV RNA testing. HCV RNA testing is critical to determine the percentage of patients that have acute HCV infection and need to be linked to care and curative antiviral therapy.

CDC recommends that all specimens needed to diagnose HCV be collected in a single visit and HCV RNA testing be performed automatically when the HCV antibody is reactive.  “Reflex” testing should happen in the laboratory without additional action on the part of the patient or the healthcare provider. Reflex testing is critical to determine the number of people diagnosed with current HCV infection who need to be linked to care and curative antiviral therapy.

CDC Operational Strategies to Diagnose Current HCV Infection

• From a single venipuncture, two specimens are collected in separate tubes.
• One tube is used for the initial HCV antibody test, and if reactive, the second tube is used for the reflexed HCV RNA test, without another blood draw.
• If the initial testing for HCV antibody was performed using finger-stick blood, then a separate venipuncture specimen should be drawn at the same time, in one tube, and submitted for HCV RNA testing, if the HCV antibody test is positive.

These strategies allow for single-visit specimen collection, which ensures that HCV RNA testing can be performed automatically without requiring a separate health care visit. 

***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.

In 2023 a needs assessment of Montana laboratories who conduct the majority of HCV testing identified the following barriers to HCV reflex testing:

1. A lack of provider knowledge of HCV testing algorithms, which can lead to errors or confusion in the ordering process
2. Issues with computer/technology systems (e.g., lack of an integrated computer system for different hospitals and clinics in one private healthcare system)

Recommendations to address these barriers include:

1. Implement reflex testing procedures for all HCV tests
2. Educate facility medical providers on HCV testing algorithms and specimen collection recommendations
3. Encourage facilities to implement a patient alert on the EMR to test patients in accordance with the CDC’s algorithm

The Montana Public Health Laboratory offers a Hepatitis C RNA Quantitation test.  To order, use the code “HCV RNA Quant” in the laboratory portal.  The specimen requirement is 2 mL serum separated from the cells within 6 hours of collection; then stored at 2-8°C and shipped within 2 days of collection.  The CPT code is 87522 and cost is $115.