[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MagIA Diagnostics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100606069","clinical-performance-evaluation-of-magia-ivd-md-multiplex-testing-hivhbvhcvsyphilis-100606069",false,"NCT07170748","Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV\u002FHBV\u002FHCV\u002FSyphilis)","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","MAGICS IBCS","Inclusion Criteria:\n\n* Provide informed consent for participation in this study.\n* Patient sample must meet at least one of the criteria below:\n\n  1\\. Positive samples (serum or plasma) from individuals who meet at least one of the following conditions:\n* HIV-1 Ab positive\n* HIV-2 Ab positive\n* HCV-Ab positive\n* HBsAg positive\n* 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:\n* Blood donors\n* Hospitalized patients or individuals coming to the clinic\n* 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:\n* Being a pregnant woman\n* 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\n* Presenting any of the following criteria:\n\n  * High IgG levels\n  * High rheumatoid factor (\\>15 IU\u002FmL)\n  * High cholesterol levels (\\>0.24 md\u002FdL)\n  * High bilirubin levels (\\>0.25 mg\u002FmL)\n  * High triglyceride levels (\\>500 mg\u002FdL)\n  * Diagnosis of cancer\n\nExclusion Criteria:\n\n* Samples from patients below 18 years of age",true,"ALL","18 Years",{"count":21,"type":22},2950,"ESTIMATED","OBSERVATIONAL","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.",[26,27,28,29,30,31],"Multiplex Testing of HIV, HBV, HCV and Syphilis","HIV","HBV","HCV","Syphilis","Point of Care Testing",[33,27,28,29,30,34],"point of care test","multiplex testing","RECRUITING","2026-01-30",{"date":38,"type":39},"2026-02-02","ACTUAL",{"date":41,"type":39},"2025-07-29",{"date":43,"type":22},"2026-04",{"name":45,"class":46},"MagIA Diagnostics","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":17,"sex":54,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":5},"100522416","prospective-clinical-performance-evaluation-of-the-in-vitro-diagnostics-medical-device-magia-ibc-for-the-combined-screening-of-hiv-hepatitis-b-and-hepatitis-c-100522416","NCT06082336","Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C","MAGICIEN","Inclusion Criteria:\n\nIC1. A Male or Female aged of at least 18 years\n\nIC2. A person responding to one of the following conditions:\n\n* known having HIV infection\n* or known having HBV infection\n* or known or suspected having HCV infection with anti-HCV RDT positive. IC3. A person having given consent to participate the study, IC4. A person covered by a medical insurance or being enrolled during an outdoor testing campaign.\n\nExclusion Criteria:\n\nEC1. A person for whom blood sampling would represent a risk, EC2. A person protected by law (minor, under guardianship or curatorship, childbearing, or breastfeeding female, hospitalized without consent, under administrative or judicial supervision)","MALE",{"count":56,"type":22},252,"INTERVENTIONAL",[59],"NA","Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV antibodies (HIV-Ab), anti-HCV antibodies (HCV-Ab), and HBs antigens (HBs-Ag) in serum, plasma, venous blood and capillary blood. If not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study.\n\nThe Study includes a Technical Adjustment Phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a Validation Phase (to validate the concordance between the matrices and to evaluate the Specificity and the Sensibility of the diagnostics).\n\nValidation Phase is between Sept. 2024 and still ongoing.",[62],"Combined Point of Care Diagnostic of HIV, HBV and HCV",[64,27,29,28],"point of care diagnostic",{"date":66,"type":39},"2026-02-03",{"date":68,"type":39},"2024-09-16",{"date":70,"type":22},"2026-11",{"name":45,"class":46},""]