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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Establishment of Rapid Diagnostic Procedure of HCV Single-sample Detection Platform in China

Conditions
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Hepatitis C Virus Infection

Intervention / Treatment
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* Diagnostic Test: Anti-HCV antibody and HCV core antigen testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Anti-HCV antibody and HCV core antigen testing|HCV antibody screening were carried out with rapid diagnostic testings (RDTs) by colloidal gold method, using fingertip blood or residual blood from other testings. For samples with positive HCV antibody RDTs screening results, HCV core antigen detection will be carried out subsequently as diagnostic test. HCV core antigen detection will be conducted with chemiluminescent particle immunoassay using residual blood from other testings.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of rapid diagnostic processes | Completion rate of rapid diagnostic processes | 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of HCV infection | The prevalence of HCV infection in the population attending each center (including physical examination) | 1 day | 
| The proportion of abnormal fibroscan results, liver function, blood routine, and ultrasound data in HCV-infected people | For example, the confirmed rate of HCV infection in the screening population was much higher than that of HCV infection in the region in the epidemiological survey, and the degree of liver fibrosis and cirrhosis assessed by the confirmed population through this process was significantly lower than the mean HCV population reported in the literature, which indirectly reflected the potential benefit of rapid diagnosis process in helping to detect HCV infection missed in routine visits (including physical examination). | 30 days | 
| Additional time required by the testing process | Additional time required by the testing process | 1 day | 
| The feedback and evaluation from study participants | Feedback and assessments of study participants were collected using the Clinical Trial Participant Satisfaction Questionnaire (including whether it affects routine visits (including physical examination) procedures, and the acceptance of this process, etc.) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus Infection, Rapid diagnostic tests, RDTs, Anti-HCV antibody, HCV core antigen