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NCT03896087

Evaluation of Dried Blood Spot for HCV RNA Testing

Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
Foundation for Innovative New Diagnostics, Switzerland·ClinicalTrials.gov·diagnostic testCompleted
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Study focus
Disease/Condition
Hepatitis C, Chronic
Drug/Device/Intervention
Abbott RealTime HCV assay from DBS
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Foundation for Innovative New Diagnostics, Switzerland
Location
Victoria Park,Yaoundé,Tbilisi,Athens,Kigali, Australia,Cameroon,Georgia,Greece,Rwanda
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2019
End date
Dec 01, 2020
Enrollment
942 participants
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
Chronic viral hepatitis CAcute hepatitis CChronic hepatitis, unspecifiedChronic viral hepatitisChronic viral hepatitis, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03896087
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.