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Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C

NCT06082336 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2026-02-03

No results posted yet for this study

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.

Conditions

  • Combined Point of Care Diagnostic of HIV, HBV and HCV

Interventions

DIAGNOSTIC_TEST

MagIA IBC test in capillary blood

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

DIAGNOSTIC_TEST

MagIA IBC test in other blood matrices

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

Sponsors & Collaborators

  • MagIA Diagnostics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2025-08-26
Completion
2026-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06082336 on ClinicalTrials.gov