NCT05906459

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-26
• Primary completion: 2023-12-30
• Completion: 2024-06-30
• First posted: 2023-06-15
• Last updated: 2023-07-17

Locations

3 sites across 1 country: China