HCV Microfluidic Diagnostics

Completed

• Conditions: Hepatitis C

• Registration Number: NCT06047275
• Lead Sponsor: University of Hull

Brief Summary

Hepatitis C diagnostic devices have been developed at the University of Hull to detect and quantify the Hepatitis C virus in patients' plasma and serum samples. This study aims to test the new point-of-care devices that are designed to be low cost and user-friendly.

Excess, stored, HCV patients' plasma, serum and blood samples will be supplied by the Virology laboratory (Hull University Teaching Hospital's Trust; HUTH). These samples were taken and analysed as part of patients' clinical monitoring, and are stored prior to disposal in the Virology laboratory. The proposed study will use the samples in a fully anonymised manner.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Blood sample taken

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of Microfluidic device with serum and plasma	30 minutes	A new paper and electrochemical microfluidic device was tested with serum and plasma samples from known HCV positive samples and normal controls. The controls allowed a threshold level to be determined and all plasma and serum samples gave positive results and these were correlated with the previously acquired clinical data.

Trial Locations

Locations (1)

University of Hull; 🇬🇧 Kingston upon Hull, United Kingdom