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| Name | Class |
|---|---|
| Institut Pasteur | INDUSTRY |
| Kenya Medical Research Institute | OTHER |
| Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville | Recruiting | Abidjan | Côte d’Ivoire |
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| Label | URL |
|---|---|
| Related Info | View source |
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IPD belonging to the patients are confidential and shall not be shared. It is not planned in the protocol.
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| 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. | Baseline |
| Kenya Medical Research Institute (KEMRI) | Recruiting | Nairobi | Kenya |
|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |