A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases (SAFE-Blood)

A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases (SAFE-Blood)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Viral Hepatitis

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Edouard TUAILLON, MD, PhD; Phone Number: 33 467 338 469; Email: e-tuaillon@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Collection of human biological samples integrated into the laboratory's declared collections. These samples come from major subjects taken as part of a diagnostic or monitoring procedure for infection with viral hepatitis or HIV

Description

Inclusion criteria:

- Samples having been tested positive or negative for the serological markers explored in the study

Exclusion criteria:

- to refuse to participate to the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Analytical performances	Analytical performances	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Field evaluation	Field evaluation	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Edouard TUAILLON, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (ACTUAL): March 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Serological assays
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: RECHMPL20_0141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No