On June 27, 2024, the U.S. Food and Drug Administration (FDA) granted marketing authorization to Cepheid for the Xpert HCV VL Fingerstick test. This is the first hepatitis C virus (HCV) test that can be used to diagnose in the point-of-care setting. This means that people can be tested in many settings including substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments, pharmacies, and urgent care clinics. This is a huge breakthrough because prior to this test, a multi-step process including a blood draw sent to a central lab for testing was required. Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease, mainly because of lack of available, convenient, and widespread testing options. This has the potential to create more access to treatment
What is Hepatitis C?
Hepatitis C is a liver disease that is caused by the hepatitis C virus. Left untreated, hepatitis C can lead to serious liver problems like scarring and liver cancer. HCV is a bloodborne virus that is transmitted through exposure to blood through unsafe injection practices, unsafe health care, injection drug use, and sexual practices that lead to exposure to blood. In 2021, 43 states reported a total of 107,300 newly identified chronic hepatitis C infections. This averages out to 39.7 cases per 100,000 people. Globally, it is estimated that 242,000 people died from hepatitis C in 2022, mostly from primary liver cancer and cirrhosis (permanent scarring that damages your liver that interferes with its function).
How does the new test work?
To confirm someone has an active hepatitis C infection, HCV RNA also known as viral load must be detectable. The viral load of hepatitis C refers to the amount of the virus present in the bloodstream. This HCV RNA test was previously only available through blood draw and central lab processing. The Xpert HCV VL Fingerstick test takes a drop blood from a fingerstick (similar to image above) and will detect and give the amount of HCV RNA in the sample in approximately one hour.
Prepared by Adam Tanigunchi PharmD
Resources:
- https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test
- gov/hepatitis-c/about/index.html
- https://www.who.int/news-room/fact-sheets/detail/hepatitis-c#:~:text=The%20hepatitis%20C%20virus%20is,lead%20to%20exposure%20to%20blood.
- https://www.cdc.gov/hepatitis/statistics/2021surveillance/hepatitis-c.htm#:~:text=Hepatitis%20C%2Dassociated%20deaths%20during,4.13%20deaths%20per%20100%2C000%20people).
- va.gov/hcv/patient/diagnosis/labtests-RNA-quantitative-testing.asp
- https://www.cepheid.com/en-GB/tests/blood-virology-womens-health-sexual-health/xpert-hcv-vl-fingerstick.html#nav-id-2
