Hepatitis C Lab Testing Comparison Study
Stopped early
Conditions studied: Hepatitis C
In brief
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.
Key facts
- Study ID
- NCT06380166
- Run by
- HealthPartners Institute
- People needed
- 1
- Starts
- 2024-07-24
- Expected to finish
- 2024-12-06
- Last updated by the study team
- 2025-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able to provide informed consent
- Had detectable HCV VL in a standard of care Hepatitis C RNA Quantitative test
- Initial hepatitis C VL testing took place at any HealthPartners lab
- Able to undergo a study blood draw within 3 weeks of initial hepatitis C VL testing
- Ability to sign e-consent prior to presenting for a study lab draw
You may not qualify if…
- Age <18 years
- On the HealthPartners research opt-out list
- HCV VL not detectable at follow-up lab draw (screen fail)
Where it is running
- HealthPartners — Bloomington, Minnesota, United States
Full record on ClinicalTrials.gov
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