Hepatitis C Lab Testing Comparison Study

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.

Study Overview

• Status: Terminated
• Conditions: Hepatitis C
• Intervention / Treatment: Diagnostic test: Hepatitis C core antigen

Detailed Description

This study seeks to test the stability of a novel method of hepatitis-C testing called HCV core antigen testing. This will be accomplished by prospectively consenting patients who have had a recent, positive standard of care HCV viral load test, and drawing additional blood to conduct HCV core antigen testing within the infectious period. Viral load amount of the core antigen test will be recorded at baseline and subsequent timepoints. Stability is defined as <10% change from baseline and will be recorded at various timepoints up to 144 hours post-draw. Stability will also be tested at room temperature vs. refrigerated storage and on the gel vs. off the gel processing techniques. This information is necessary to ensure HCV core antigen is sufficiently stable following specimen collection to enable robust, accurate, and precise measurement using the HCV core antigen assay.

• Study Type: Observational
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • HealthPartners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals who have tested positive for Hepatitis C

Description

Inclusion Criteria:

• 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 Criteria:

• Age <18 years
• On the HealthPartners research opt-out list
• HCV VL not detectable at follow-up lab draw (screen fail)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
In vitro stability investigation	Diagnostic test: Hepatitis C core antigen; Semi-quantitative, automated immunoassay detecting core antigen of hepatitis C virus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum on the clot stability	Determine the 48-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at ambient temperatures (20.0-25.0 C) and collected from patients with detectable HCV VLs who completed standard of care Hepatitis C RNA Quantitative testing within the prior 2 weeks. Determine the 144-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at refrigerated temperatures (2.0-8.0 C) and collected from patients with detectable HCV VLs who completed standard of care Hepatitis C RNA Quantitative testing within the prior 2 weeks.	6 days
Serum off the clot stability	Determine the 48-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at ambient temperatures (20.0-25.0 C) and collected from patients with detectable HCV VLs who completed standard of care Hepatitis C RNA Quantitative testing within the prior 2 weeks. Determine the 144-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at refrigerated temperatures (2.0-8.0 C) and collected from patients with detectable HCV VLs who completed standard of care Hepatitis C RNA Quantitative testing within the prior 2 weeks.	6 days
Plasma on the gel stability	Determine the 48-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at ambient temperatures (20.0-25.0 C) and collected from patients with detectable HCV VLs who completed standard of care Hepatitis C RNA Quantitative testing within the prior 2 weeks. Determine the 144-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at refrigerated temperatures (2.0-8.0 C) and collected from patients with detectable HCV VLs who completed standard of care Hepatitis C RNA Quantitative testing within the prior 2 weeks.	6 days
Plasma off the gel stability	Determine the 48-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at ambient temperatures (20.0-25.0 C) and collected from patients with detectable HCV VLs who completed standard of care Hepatitis C RNA Quantitative testing within the prior 2 weeks. Determine the 144-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at refrigerated temperatures (2.0-8.0 C) and collected from patients with detectable HCV VLs who completed standard of care Hepatitis C RNA Quantitative testing within the prior 2 weeks.	6 days

Collaborators and Investigators

• Sponsor: HealthPartners Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): December 6, 2024

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; Flaviviridae Infections; Hepatitis A; Hepatitis; Hepatitis C
• Other Study ID Numbers: A23-356

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No