Multiplex Testing of HIV, HBV, HCV and SyphilisMAGICS IBCSNCT07170748
Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
An observational study of Multiplex Testing of HIV, HBV, HCV and Syphilis and HIV, run by MagIA Diagnostics at 2 sites in 2 countries.
Trial summary
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from serum, plasma samples collected prospectively or retrospectively in Ivory… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV
- How many people
- 2,950 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Jul 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- Samples from patients below 18 years of age
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville
Abidjan
Andre INWOLEY, Pr, (+225) 27 21 39 15 26, andre.inwoley@cedres.org
Andre INWOLEY, Pr
Kenya1 site, 1 recruiting
- Recruiting
Kenya Medical Research Institute (KEMRI)
Nairobi
Samoel KHAMADI, Dr, (+254) 0722 205 901, skhamadi@kemri.go.ke
Samoel KHAMADI, Pr
About this study
Official title: Clinical Performance Evaluation of MagIA In-vitro Diagnostic Medical Device for Multiplex Screening of Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C and Syphilis in Sub-Saharan Africa
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from serum, plasma samples collected prospectively or retrospectively in Ivory Coast and Kenya.
- Conditions
- Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV, Syphilis, Point of Care Testing
- Keywords
- point of care test, HIV, HBV, HCV, Syphilis, multiplex testing
- Medical subject headings
- Hepatitis B, Hepatitis C, Syphilis
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab
Diagnostic sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) of the MagIA H3S device for detecting each of the four markers: HIV-Ab, HCV-Ab, HBsAg, and TP-Ab, compared to reference standard testing.
Measured: Baseline
Secondary outcomes (2)
Evaluation of cross-reactivity with any potentially interfering substances or interferences with any co-infection or comorbidity
Identification and collection of suspected and predefined cross-reacting or interfering substances (e.g. alcohol, tobacco, concomitant medication) and comorbidities (e.g. HTLV, EBV, CMV, HSV, malignancy).
Samples with inconclusive results from MagIA test and those with discordant results between MagIA and reference tests will be further examined for the presence of cross-reacting substances or underlying comorbidities that may influence the signal of the MagIA H3S test. Identified interfering substances will be documented through eCRF and additional analytical investigations will be conducted to confirm their impact.
Measured: Baseline
Evaluation of performance of MagIA H3S in determining on-going HCV infection
Sensitivity, specificity, positive predictive value, and negative predictive value of the MagIA H3S HCV score to detect on-going HCV infection compared to the gold standard, considering only those with positive RNA viral load assay as positive for HCV.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start29 Jul 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiplex Testing of HIV, HBV, HCV and SyphilisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MagIA Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur, Kenya Medical Research Institute, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170748
- Sponsor's protocol ID
- MAGIA-H3S-EP-01
- Acronym
- MAGICS IBCS
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD belonging to the patients are confidential and shall not be shared. It is not planned in the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of MagIA In-vitro Diagnostic Medical Device for Multiplex Screening of Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C and Syphilis in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT07170748
- Acronym / sponsor ID
- MAGICS IBCS / MAGIA-H3S-EP-01
- Conditions
- Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV, Syphilis, Point of Care Testing
- Keywords
- point of care test, HIV, HBV, HCV, Syphilis, multiplex testing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,950 participants (estimated)
- Lead sponsor
- MagIA DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur, Kenya Medical Research Institute, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from serum, plasma samples collected prospectively or retrospectively in Ivory Coast and Kenya.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (1 listed)
- Samples from patients below 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab
Time frame: Baseline
Diagnostic sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) of the MagIA H3S device for detecting each of the four markers: HIV-Ab, HCV-Ab, HBsAg, and TP-Ab, compared to reference standard testing.
2 secondary outcomes
Evaluation of cross-reactivity with any potentially interfering substances or interferences with any co-infection or comorbidity
Time frame: Baseline
Evaluation of performance of MagIA H3S in determining on-going HCV infection
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD belonging to the patients are confidential and shall not be shared. It is not planned in the protocol.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville
Abidjan, Côte d’Ivoire
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiplex Testing of HIV, HBV, HCV and Syphilis and HIV, run by MagIA Diagnostics at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Côte d’Ivoire, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.