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November 18, 2024
COMMUNITY AND GLOBAL HEALTH
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December 10, 2025
COMMUNITY AND GLOBAL HEALTH
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The Need
- Diagnosis of HCV viremia can be complex with up to five clinical visits.1
- Confirmation of viremia with HCV RNA for positive antibody-based tests requires venipuncture, preparation and transport of blood specimens, laboratory expertise, and days/weeks to obtain results.2
- An HCV RNA test at the point of care, has potential to simplify testing algorithms, increase diagnosis rates, and lead to increased linkage to care.
1 Grebely J., et al (2017): Hepatitis C point-of-care diagnostics: in search of a single visit diagnosis, Expert Review of Molecular Diagnostics, DOI:10.1080/14737159.2017.1400385
2 Updated recommendations on simplified service delivery and diagnostics for hepatitis C infection: policy brief 2022
2 Updated recommendations on simplified service delivery and diagnostics for hepatitis C infection: policy brief 2022
The Solution
- The Xpert® HCV VL Fingerstick test is intended to be used as an aid in the initial diagnosis in individuals at high risk of HCV infection or in anti-HCV positive individuals, as well as an aid in the management of HCV infected patients undergoing antiviral therapy.
- The point-of-care test simplifies diagnosis of Hepatitis C infections by providing patients with viral load results in a single visit in less than an hour, thereby offering immediate linkage to care.
The Impact
- Simplifies HCV diagnosis: shifting from five steps1 to a one step test-and-treat model of care speeds up time to treatment and reduces loss to follow-up.3
- Improves access to testing for those at highest risk: point-of-care testing in community settings enables reaching the populations most vulnerable to HCV infection.
- Increases diagnosis and linkage to care: increased uptake for HCV treatment and transmission prevention.
3 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