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NCT06380166Not yet recruiting

Hepatitis C Lab Testing Comparison Study

HealthPartners InstituteClinicalTrials.govdiagnostic test
Study focus
Disease/Condition
Hepatitis C
Drug/Device/Intervention
Hepatitis C core antigen
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
HealthPartners Institute
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Sep 01, 2024
Enrollment
25 participants
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
Acute hepatitis CChronic viral hepatitis CViral hepatitisChronic viral hepatitisUnspecified viral hepatitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06380166
Type
Non-Device Trial
About this record

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.

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.