MedTrace Logo

Hepatitis C Lab Testing Comparison Study

NCT06380166 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2025-01-06

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DIAGNOSTIC_TEST

Hepatitis C core antigen

Semi-quantitative, automated immunoassay detecting core antigen of hepatitis C virus.

Sponsors & Collaborators

  • HealthPartners Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-24
Primary Completion
2024-08-20
Completion
2024-12-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06380166 on ClinicalTrials.gov