HIV Clinical Trial
— SAFE-BloodOfficial title:
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | December 30, 2023 |
| Est. primary completion date | December 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Uhmontpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Analytical performances | Analytical performances | day 1 | |
| Secondary | Number of Field evaluation | Field evaluation | day 1 |
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|---|---|---|---|
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