NCT06082336

Brief Summary

Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV antibodies (HIV-Ab), anti-HCV antibodies (HCV-Ab), and HBs antigens (HBs-Ag) in serum, plasma, venous blood and capillary blood. If not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study. The Study includes a Technical Adjustment Phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a Validation Phase (to validate the concordance between the matrices and to evaluate the Specificity and the Sensibility of the diagnostics). Validation Phase is between Sept. 2024 and still ongoing.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Sep 2024Nov 2026

First Submitted

Initial submission to the registry

October 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

October 2, 2023

Last Update Submit

January 30, 2026

Conditions

Combined Point of Care Diagnostic of HIV, HBV and HCV

Keywords

point of care diagnosticHIVHCVHBV

Outcome Measures

Primary Outcomes (1)

  • Clinical Performance of the MagIA IBC test in determining the serological status of HIV infection, HCV infection (current infection only) and HBV infection

    For each of the 3 diagnostics, the corresponding Endpoints are the Sensitivity (Se) and Specificity (Sp) of MagIA IBC.

    baseline

Secondary Outcomes (2)

  • Concordance of the results delivered by MagIA IBC for HIV and HBV, on each of the selected matrices (i.e. serum, plasma, venous and capillary blood).

    baseline

  • Adverse events of MagIA IBC test

    1 day

Study Arms (1)

Single arm

EXPERIMENTAL

This study is single arm.

Diagnostic Test: MagIA IBC test in capillary bloodDiagnostic Test: MagIA IBC test in other blood matrices

Interventions

MagIA IBC test in capillary bloodDIAGNOSTIC_TEST

After a finger prick, patients will be taken a drop of capillary drop. This drop will be used to perform the MagIA IBC test.

Single arm
MagIA IBC test in other blood matricesDIAGNOSTIC_TEST

Blood samples will be taken and used to perform the MagIA IBC in veinous blood, serum and plasma, except for outdoor tested subjects

Single arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IC1. A Male or Female aged of at least 18 years
  • IC2. A person responding to one of the following conditions:
  • known having HIV infection
  • or known having HBV infection
  • or known or suspected having HCV infection with anti-HCV RDT positive. IC3. A person having given consent to participate the study, IC4. A person covered by a medical insurance or being enrolled during an outdoor testing campaign.

You may not qualify if:

  • EC1. A person for whom blood sampling would represent a risk, EC2. A person protected by law (minor, under guardianship or curatorship, childbearing, or breastfeeding female, hospitalized without consent, under administrative or judicial supervision)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Européen de Marseille

Marseille, France, 13003, France

COMPLETED

Centre Hospitalier de Perpignan - Equipe Mobile Hépatites

Perpignan, 66000, France

RECRUITING

MeSH Terms

Conditions

Hepatitis BHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae InfectionsRNA Virus Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 13, 2023

Study Start

September 16, 2024

Primary Completion

August 26, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

FR(2)