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

University Hospital Center (CHU)

Status: Unknown

Conditions: HIV; Viral Hepatitis

Study type: Observational

Funder types: Other

Identifiers

NCT04304612

RECHMPL20_0141

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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