Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMagIA Diagnostics
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provide informed consent for participation in this study.
HIV-1 Ab positive
HIV-2 Ab positive
HCV-Ab positive
Disqualifiers
Samples from patients below 18 years of age
Trial 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
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
BaselineSecondary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
MagIA Diagnostics
Lead sponsor
Institut Pasteur
Collaborator
Kenya Medical Research Institute
Collaborator
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
Collaborator
Source ClinicalTrials.gov