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COMMUNITY AND GLOBAL HEALTH
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May 28, 2025
COMMUNITY AND GLOBAL HEALTH
The Need
- Under diagnosis of HCV remains one of the most significant barriers to HCV elimination and public health with only 49%– 55% of people with chronic HCV disease aware of their infection status.1
- A diagnostic algorithm for HCV infection that requires multiple tests and multiple clinical appointments results in patients being lost before being treated.2
- Simplifying the diagnostic pathway can shorten time to treatment, reduce loss to follow up, and prevent the risk of onward transmission. 2
- Tests that detect active HCV infection, performed in CLIA waived settings have the potential to reach more peopleand improve overall diagnosis and linkage to care rates.1
1 Page and Feinberg. What Hepatitis C Virus (HCV) Diagnostic Tools Are Needed to Advance Diagnosis of Current HCV Infection in Outreach Settings and in a Nonclinical Setting? JID 2024, https://doi.org/10.1093/infdis/jiad269
2 Applegate TL, Fajardo E, Sacks JA. Hepatitis C Virus Diagnosis and the Holy Grail. Infect Dis Clin North Am. 2018;32(2):425-445. doi:10.1016/j.idc.2018.02.010
2 Applegate TL, Fajardo E, Sacks JA. Hepatitis C Virus Diagnosis and the Holy Grail. Infect Dis Clin North Am. 2018;32(2):425-445. doi:10.1016/j.idc.2018.02.010
The Solution
- Xpert HCV is a CLIA waived test that can be performed using a fingerstick capillary whole blood sample in point of care settings. The test can be used to determine the HCV infection status of individuals at risk of HCV with or without antibodies to HCV, and can therefore be utilized as part of a one-step testing algorithm for active HCV infection.
- Xpert HCV can be used as part of a “test and treat” model of care, potentially saving time between initial evaluation and treatment initiation, retaining more patients in care, and has the ability to support increase identification of individuals who may be candidates for treatment.
The Impact
- Simplifies HCV diagnosis: Xpert HCV detects viral RNA and does not require antibody testing, enabling a one-step testing algorithm for detection, speeding up the time to treatment and reducing the number of patients lost to follow up3
- Improves access to testing for those at highest risk: HCV RNA point-of-care testing can be delivered in settings to reach and diagnosis individuals at highest risk of infection3
- Provides same‑day results that support timely clinical decision‑making
1 Page and Feinberg. What Hepatitis C Virus (HCV) Diagnostic Tools Are Needed to Advance Diagnosis of Current HCV Infection in Outreach Settings and in a Nonclinical Setting? JID 2024, https://doi.org/10.1093/infdis/jiad269
2 Applegate TL, Fajardo E, Sacks JA. Hepatitis C Virus Diagnosis and the Holy Grail. Infect Dis Clin North Am. 2018;32(2):425-445. doi:10.1016/j.idc.2018.02.010
2 Applegate TL, Fajardo E, Sacks JA. Hepatitis C Virus Diagnosis and the Holy Grail. Infect Dis Clin North Am. 2018;32(2):425-445. doi:10.1016/j.idc.2018.02.010
A Call to Action
The Viral Hepatitis National Strategic Plan for the United States calls for greater than 80% of people with hepatitis C to achieve viral clearance by 2030*. Currently, the diagnostic pathway for detection of hepatitis C faces many barriers, including complicated multi-step diagnostic algorithms based on antibody screening and RNA confirmation**. These algorithms require centralized testing technologies that may result in treatment delays and discourage at-risk populations from accessing testing and receiving care.
* US Department of Health and Human Services. Viral Hepatitis National Strategic Plan for the United States: a roadmap to elimination for the United States, 2021–2025. Washington, DC: US Department of Health and Human Services; 2020. https://www.hhs.gov/sites/default/files/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf
** Karon C Lewis, Laurie K Barker, Ruth B Jiles, Neil Gupta, Estimated Prevalence and Awareness of Hepatitis C Virus Infection Among US Adults: National Health and Nutrition Examination Survey, January 2017–March 2020, Clinical Infectious Diseases, Volume 77, Issue 10, 15 November 2023, Pages 1413–1415.
Transforming Patient Care
With Cepheid’s Xpert® HCV, patients can undergo testing, receive a diagnosis, and seamlessly connect to treatment and care in a single visit. This efficient process has the potential to save time and can ensure more patients stay in care, leading to more people cured of hepatitis C.
“This simple to use test detects the full range of relevant HCV genotypes in about an hour and can be performed on a small volume of blood collected via fingerstick.”
David H. Persing, M.D., Ph.D.
Cepheid's Chief Medical and Technology Officer
This simple to use test detects the full range of relevant HCV genotypes in about an hour and can be performed on a small volume of blood collected via fingerstick.
Ease of Use
1
Collect 250-500uL fingerstick whole blood in BD Microtainer®^
2
Transfer 100uL of the sample into the cartridge using the pipette provided
3
Insert cartridge and start test
IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.
*K2 EDTA Microtainer (BD part number: 365974) not provided in the kit.
Cepheid’s CLIA waived Xpert® HCV test, authorized by the FDA, allows complete hepatitis C RNA testing at the point-of-care. The test runs on the Xpert® GeneXpert system, enabling any trained healthcare professional, regardless of skill level, to administer the test. This easy-to-use solution provides Lab in a Cartridge™ results when and where they are needed.
The Impact of Point of Care Hepatitis C Testing Globally
3. Centers for Disease Control (2023, December 23). Treatment of Hepatitis C. CDC https://www.cdc.gov/hepatitis-c/treatment/index.html
4. CDC (2023, August 7). Hepatitis C Surveillance 2021. CDC Viral Hepatitis. Retrieved May 28, 2024, from https://www.cdc.gov/hepatitis-surveillance-2021/hepatitis-c/
5. World Health Organization (2024, April 9). Hepatitis C. Retrieved June 4, 2024, from https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
7. Centers for Disease Control (2024, March 14). Hepatitis C Surveillance Guidance. CDC Viral Hepatitis. https://www.cdc.gov/hepatitis/statistics/surveillanceguidance/HepatitisC.htm
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