HBV, HCV, HIV, Multiplex Testing of HIV, HBV, HCV and Syphilis, Point of Care Testing, Syphilis
Conditions
Keywords
point of care test, HIV, HBV, HCV, Syphilis, multiplex testing
Brief 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 Coast and Kenya.
Interventions
None listed
Sponsors
MagIA Diagnostics
Institut Pasteur
Kenya Medical Research Institute
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of cross-reactivity with any potentially interfering substances or interferences with any co-infection or comorbidity | Baseline | 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. |
| Evaluation of performance of MagIA H3S in determining on-going HCV infection | Baseline | 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. |
Countries
Côte d’Ivoire, Kenya
Outcome results
None listed