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One test, four diseases: could this be the end of missed diagnoses?

NCT ID NCT07170748

Diagnosis Sponsor: MagIA Diagnostics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called MagIA H3S that can screen for HIV, hepatitis B, hepatitis C, and syphilis using a single blood sample. Researchers will enroll about 2,950 people in Ivory Coast and Kenya to see how accurate the device is compared to standard lab tests. If it works well, it could make widespread screening easier in areas with limited healthcare resources.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MagIA H3S diagnostic device
What this could lead to
If successful, this could provide a fast, affordable way to test for four major infections at once, improving early detection in remote areas.
What could go wrong
This is a performance evaluation, not a treatment trial. The device may not be as accurate as lab tests, and results may vary across populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,950 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of blood samples from individuals recruited from those seeking viral load testing and diagnostic services for HIV, HBV, HCV, and syphilis or from individuals belonging to one of the target populations of the study

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Provide informed consent for participation in this study. * Patient sample must meet at least one of the criteria below: 1\. Positive samples (serum or plasma) from individuals who meet at least one of the following conditions: * HIV-1 Ab positive * HIV-2 Ab positive * HCV-Ab positive * HBsAg positive * Positive for at least TPHA, with those positive for both TPHA and VDRL ideally included 2. Negative samples (serum or plasma) from individuals who meet at least one of the following conditions: * Blood donors * Hospitalized patients or individuals coming to the clinic * Vulnerable populations (such as: drug users, prison population, ...) 3. Negative samples (serum or plasma) containing potential interfering substances from individuals who meet at least one of the following conditions: * Being a pregnant woman * Infected with at least one of the following viruses or bacteria: hepatitis A virus (HAV), hepatitis E virus (HEV), tuberculosis (TB), gonorrhoea, chlamydia, influenza virus, Covid-19 * Presenting any of the following criteria: * High IgG levels * High rheumatoid factor (\>15 IU/mL) * High cholesterol levels (\>0.24 md/dL) * High bilirubin levels (\>0.25 mg/mL) * High triglyceride levels (\>500 mg/dL) * Diagnosis of cancer Exclusion Criteria: * Samples from patients below 18 years of age

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection hepatitis C virus infection HIV infectious disease syphilis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HBV HCV HIV Multiplex testing of HIV, HBV, HCV and syphilis Point of care testing Syphilis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville

    RECRUITING

    Abidjan, Côte d’Ivoire

  • Kenya Medical Research Institute (KEMRI)

    RECRUITING

    Nairobi, Kenya

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