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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

ConditionCombined Point of Care Diagnostic of HIV, HBV and HCV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorMagIA Diagnostics

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • MagIA IBC test in capillary blood

    Diagnostic 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.

  • MagIA IBC test in other blood matrices

    Diagnostic test

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

Treatment groups

252 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
baseline

Secondary outcomes

1

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).

For HIV and HBV, the corresponding Endpoint is the Kappa coefficient calculated for each of the 6 concordance tables comparing the results in the selected matrices.

Time frame
baseline
2

Adverse events of MagIA IBC test

Adverse events will be collected to assess safety of the device.

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MagIA Diagnostics

Lead sponsor

Source ClinicalTrials.gov
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