Simplification and Test and Treat Strategies Towards Hepatitis C Eliminationplatform" in China(STAT)

Fudan University

Status: Enrolling

Conditions: Hepatitis C Virus Infection

Treatments: Diagnostic Test: Anti-HCV antibody and HCV core antigen testing

Study type: Observational

Funder types: Other

Identifiers

NCT05906459

STAT

Details and patient eligibility

About

The present study aims to establish a " one-sample testing platform " and assess the prevalence of hepatitis C in individuals taking routine physical examination or outpatient visit in mainland China.

Full description

Investigators intend to establish a one-sample testing platform to improve diagnosis and linkage to care process in participants under routine physical examination or outpatient visit. The platform is based on rapid diagnostic tests (RDTs) for HCV screening and HCV core antigen for confirmation. RDTs was used to screen for anti-HCV antibodies. The result of RDT will be interpreted within 15 minutes with the sensitivity of 98.9% (95%CI, 94.5% to 99.8%) and specificity of 98.9% (95%CI, 97.5% to 99.9%) using whole blood or finger-stick blood sample [3-5]. HCV core antigen is a marker of HCV replication and has a good correlation with HCV RNA in HCV-positive patients (R=0.98). A recent study suggested HCV core antigen testing could be used alternative testing for HCV RNA testing for diagnosis when HCV RNA testing was unavailable. The process of HCV core antigen test only takes 2-3 hours. "one-sample" means only one drop (10ul) of finger-stick blood or residual blood samples from other routine tests collected from patients was needed for anti-HCV antibody testing and HCV core antigen testing, which means they will not have to take another venepuncture. In addition, the use of RDT and HCV core antigen are also less costly. This approach might improve access to care, particularly in low-income and middle-income countries.

The present study aims to establish a " one-sample testing platform " in several medical institution to assess the prevalence of hepatitis C in individuals taking routine physical examination and further promote rapid diagnosis platform in mainland China, so as to achieve the goal in 2030.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. 18 years of age and older, regardless of age or gender.
• 2. The residual blood sample needs to be not less than 1ml.
• 3. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Exclusion criteria

• 1. Pregnant, lactating female and who is planning pregnancy during study period.
• 2. History of tumor or other severe, life-threating diseases.
• 3. Samples not meet collection requirements.
• 4. repeated enrollment.
• 5. HCV infection has been diagnosed.
• 6. Recent HCV RNA testing confirmed that there is no HCV infection.

Termination criteria:

• 1. Subject asked to withdraw consent.
• 2. Subjects may suffer adverse impact from the study at investigator's discretion.