NACCHO Applauds FDA Approval of First Point-of-Care RNA Hepatitis C Test

Jul 16, 2024 | Kat Kelley

On June 27, the US Food and Drug Administration (FDA) approved the Cepheid Xpert hepatitis C (HCV) test, the first-ever point-of-care RNA test for HCV. This new tool could allow same-day diagnosis of HCV and linkage to treatment, a significant improvement over existing testing methods which involve a rapid antibody test followed by a confirmatory RNA test, the results of which can take anywhere from a few days to a few weeks to obtain.

An estimated 2.4 to 4 million Americans are living with HCV, only half of whom know their status. HCV is curable in more than 95% of patients in just 8-12 weeks, but left untreated, can cause liver damage, including liver cancer. As a result of significant gaps in testing and treatment access, 2/3 of people infected with HCV are still living with the virus.

More than half of HCV cases are attributable to injection drug use (IDU), underscoring the importance of harm reduction services to prevent reusing and sharing of syringes and other drug use equipment. The War on Drugs contributes to high rates of criminal justice involvement for people who use drugs, and consequently HCV prevalence is prisons is estimated at 12-35%. This new test presents an opportunity to increase access to testing and reach the populations most inequitably impacted by HCV as this test can be performed in settings with a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, including but not limited to local health departments (LHDs), syringe services programs, or correctional facilities. As test results can be obtained within an hour, patients can be rapidly connected to care. This can reduce the number of patients who are lost to follow-up—either not receiving their test results or initiating treatment—which can be common among populations that have fewer touchpoints with or that may not be easily reached by public health and healthcare professionals.

Most local health departments (LHDs) conduct HCV surveillance, case investigation, and stakeholder and community education, and provide prevention (harm reduction) services, testing, and linkage to care. However, this work is significantly underfunded and social and structural barriers—such as stigma, the criminalization of substance use, and inadequate health insurance coverage—limit access to services, resulting in significant inequities in HCV morbidity and mortality.

This new point-of-care RNA test for HCV has the potential to increase access to testing and ensure rapid initiation of treatment, better equipping us to reach our national goal of HCV elimination. However, LHDs and their local partners will need adequate funding, training, and guidance, including to procure the necessary equipment and supplies, ensure staff are equipped to implement testing protocols, and ultimately strengthen partnerships and meaningfully engage with their communities to reach people living with HCV with testing and connect them to care.


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