A novel point-of-care hepatitis C virus test showed good diagnostic accuracy in symptomatic and at-risk patients, opening the door for improved receipt of timely treatment compared with the current two-stage testing model.
Investigators conducted a prospective multicenter study among patients at risk and/or symptomatic for HCV to evaluate the accuracy of the Xpert HCV test (Cepheid) relative to screening with FDA-approved antibody tests (Elecsys Anti-HCV II, Roche) and RNA nucleic acid amplification tests (NAATs) (cobas HCV, Roche) (ClinicalTrials.gov Identifier: NCT06508996). The Xpert test uses K2EDTA finger-stick blood, while the FDA-approved tests use venous whole blood.
Speaking to the benefits of a POC test, Andrew Aronsohn, MD, an associate professor at the University of Chicago Medicine Center for Liver Diseases, who was not involved in the study, said, “Hepatitis C is a disease that affects a lot of very vulnerable populations. So, inability to cure oftentimes is because it’s difficult for people to make it to multiple appointments and all the things that go along with that.” Thus, he stressed the importance of “having an option where somebody can get a diagnosis and potentially even get treated at that same visit.”
In total, 1,015 eligible adults were enrolled in the Xpert HCV study; 92.2% were at risk for HCV and 36.8% were symptomatic for HCV. In addition, 43.1% of the patients had a history of injection drug use, 28.9% had a history of HCV infection, 15.4% were HIV-positive, 6.7% had a history of non-HCV liver disease and 1.6% were hepatitis B–positive.
The positive percent agreement (PPA) of the Xpert HCV test with the FDA-approved antibody test and RNA NAAT-based test was 93.4% (95% CI, 87.6%-96.6%) and the negative percent agreement (NPA) was 99.8% (95% CI, 99.2%-99.9%).
When stratifying by HCV antibody reactive versus nonreactive status, the PPA and NPA remained high among the antibody reactive group, but the PPA fell to 60.0% in the antibody nonreactive group.
To the investigators, the “performance of Xpert HCV” is “clinically acceptable,” and the test “shows good ability to detect HCV RNA in individuals with active HCV infection.” The Xpert HCV received FDA marketing authorization on June 27, 2024.
Dr. Aronsohn said he believes the POC test model has the potential to increase screening and treatment rates. “You can get a qualitative RNA result from a finger-stick assay, which means that you don’t need to have a traditional venipuncture,” he explained.
This approach could provide an opportunity for “screening for hepatitis C in nontraditional settings,” such as “health fairs, mobile vans or syringe exchange programs,” Dr. Aronsohn added, noting that the fast delivery of results is also an advantage that “opens up a test-and-treat algorithm in which you can screen somebody, make the diagnosis and then potentially even treat them all at that same visit.”
Despite the potential benefits, certain challenges and considerations related to POC test use need to be considered, he said. One notable challenge, particularly when testing in nontraditional settings, is “integrating [screening data] into other health systems” or “electronic health records” in a way that keeps patient information HIPAA-compliant and enables patients to be tracked longitudinally—operations that already “happen more seamlessly” when traditional testing methods are used, Dr. Aronsohn said, adding that it also will be important to address how “positive results [will] be reported to public health entities.”
—Natasha Albaneze, MPH
Dr. Aronsohn reported no relevant financial disclosures.
This article is from the June 2025 print issue.