Hepatitis C Lab Testing Comparison Study - Trial NCT06380166
Access comprehensive clinical trial information for NCT06380166 through Pure Global AI's free database. This phase not specified trial is sponsored by HealthPartners Institute and is currently Not yet recruiting. The study focuses on Hepatitis C. Target enrollment is 25 participants.
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Study Focus
Sponsor & Location
HealthPartners Institute
Timeline & Enrollment
N/A
May 01, 2024
Sep 01, 2024
Primary Outcome
Serum on the clot stability,Serum off the clot stability,Plasma on the gel stability,Plasma off the gel stability
Summary
Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV,
 but confirmation of acute infection is relegated in the current US guidelines to polymerase
 chain reaction (PCR) which often takes multiple days and may result in a loss to follow up
 and treatment, especially in high prevalence populations. HCV core antigen is a new, research
 use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared
 instrument for clinical chemistry and immunoassay testing. The aim of the study is to
 evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens
 collected from individuals with a detectable HCV viral load (HCL VL), as per a recent
 antibody assay test, under multiple specimen storage conditions mirroring those employed in
 clinical laboratories.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06380166
Non-Device Trial