Hepatitis C Lab Testing Comparison Study
Reason given: We had difficulty recruiting this population and enrolled only one patient.
Key facts
- Where
- Bloomington, United StatesSee the site
Where in United States
- HealthPartnersBloomington, United StatesNo longer taking part
Trial details
- Who runs it
- HealthPartners Institute
- Trial code
- NCT06380166
- Record updated
- 6 January 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: HCV VL not detectable at follow-up lab draw (screen fail); Age <18 years; On the HealthPartners research opt-out list.