Evaluation of Dried Blood Spot for HCV RNA Testing - Trial NCT03896087
Access comprehensive clinical trial information for NCT03896087 through Pure Global AI's free database. This phase not specified trial is sponsored by Foundation for Innovative New Diagnostics, Switzerland and is currently Completed. The study focuses on Hepatitis C, Chronic. Target enrollment is 942 participants.
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Study Focus
Sponsor & Location
Foundation for Innovative New Diagnostics, Switzerland
Timeline & Enrollment
N/A
Apr 01, 2019
Dec 01, 2020
Primary Outcome
Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site,Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV viral load level in plasma determined by Abbott RealTime HCV VL assay performed at the clinical site
Summary
FIND is preparing a study to evaluate the performance, as measured by sensitivity and
 specificity, of four centralized assays for the detection of HCV RNA using capillary blood
 collected on dried blood spots (DBS) and plasma separation card (PSC).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT03896087
Non-Device Trial