Testing a rapid blood test for HIV, hepatitis B, hepatitis C and syphilis
Checks how well a point-of-care blood test detects several infections in adults.
Plain-language title generated from the registry record
Registry title: Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Key facts
- Where
- Nairobi, KenyaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who give blood samples to test a new rapid test for HIV, hepatitis B, hepatitis C and syphilis. Samples come from people with and without these infections.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Samples from people who test positive for HIV-1, HIV-2, hepatitis C, hepatitis B or syphilis, or negative samples from donors, clinic patients, vulnerable groups, or people with other conditions that might disturb the test.
- Biomarker or test result
- Positive samples need at least one: HIV-1 antibody, HIV-2 antibody, HCV antibody, HBsAg, or TPHA positive.
Main reasons for not taking part
- Samples from people under 18 years of age
Read by machine on 9 November 2026.
Where in Kenya
- Kenya Medical Research Institute (KEMRI)Nairobi, KenyaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MagIA Diagnostics
- Trial code
- NCT07170748
- Record updated
- 2 February 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Provide informed consent for participation in this study; Patient sample must meet at least one of the criteria below:; 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: Samples from patients below 18 years of age.