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

NCT04304612 — Unknown, 500 participants, University Hospital, Montpellier
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A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases (SAFE-Blood)

RegistryNCT04304612, acronym SAFE-Blood
StatusUnknown
Study typeObservational
Enrollment500 (Estimated)
SponsorUniversity Hospital, Montpellier (Other)
ConditionsHIV, Viral Hepatitis
Datesstart 2020-01-01, primary completion 2023-12-01 (estimated), completion 2023-12-30 (estimated), first posted 2020-03-11, last updated 2021-09-14
Locations1 site in France

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-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.

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+Outcome measures

Primary outcomes

  • Number of Analytical performances [day 1]: Analytical performances

Secondary outcomes

  • Number of Field evaluation [day 1]: Field evaluation

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
UhmontpellierMontpellierFranceRecruiting

+Investigators

  • Edouard TUAILLON, Study director, University Hospital, Montpellier