Core Antigen Test for Hepatitis C

Overseen By Ian Gunsolus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Age <18, Research opt-out, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals who can electronically consent, have recently tested positive for Hepatitis C with a detectable viral load at a HealthPartners lab, and are able to provide informed consent. They must be available for a blood draw within three weeks of their initial test.

Inclusion Criteria

I can understand and agree to the study's details.

My Hepatitis C virus levels are detectable.

I had my initial hepatitis C test at a HealthPartners lab.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Sample Collection and Testing

Participants with a recent positive HCV viral load test have additional blood drawn for HCV core antigen testing. Stability of the antigen is tested under various conditions.

6 days

Follow-up

Participants are monitored for safety and effectiveness after sample collection and testing

4 weeks

Treatment Details

Interventions

• Hepatitis C core antigen

Trial Overview The study is testing the stability of HCV core antigen in serum and plasma samples under various storage conditions using the Abbott Alinity i system. It aims to see if this new assay could be an alternative to PCR tests for confirming acute Hepatitis C infection.

Participant Groups

Group I: In vitro stability investigation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+