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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04304612

Acronym

SAFE-Blood

Enrollment

500

Registered

2020-03-11

Start date

2020-01-01

Completion date

2023-12-30

Last updated

2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Viral Hepatitis

Keywords

Serological assays

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Analytical performances	day 1	Analytical performances

Secondary

Measure	Time frame	Description
Number of Field evaluation	day 1	Field evaluation

Countries

France

Contacts

Primary ContactEdouard TUAILLON, MD, PhD

e-tuaillon@chu-montpellier.fr467 338 469

Outcome results