A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases

• Conditions: HIV; Viral Hepatitis

• Registration Number: NCT04304612
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The consortium will develop a new in vitro diagnostic (IVD) test to screen donated blood for bloodborne infectious pathogens, saving blood banks time and costs required for analysis of mandatory pathogens. The IVD test is a multiplex immunoassay that simultaneously screens for six bloodborne infectious diseases per blood sample. In this project, a mix of diagnostic protein markers will be developed and validated to lowdown an IVD test ready for commercial scale-up and CE-IVD certification.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-14
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Analytical performances	day 1	Analytical performances

Secondary Outcome Measures

Name	Time	Method
Number of Field evaluation	day 1	Field evaluation

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France