Hepatitis C Lab Testing Comparison Study

Terminated

• Conditions: Hepatitis C
• Interventions: Diagnostic Test: Hepatitis C core antigen

• Registration Number: NCT06380166
• Lead Sponsor: HealthPartners Institute

Brief 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.

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 Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-23
• Study Start: 2024-07-24
• Primary Completion: 2024-08-20
• Study Completion: 2024-12-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
In vitro stability investigation	Hepatitis C core antigen	-

Primary Outcome Measures

Name	Time	Method
Serum off the clot stability	6 days	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.
Serum on the clot stability	6 days	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.
Plasma on the gel stability	6 days	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.
Plasma off the gel stability	6 days	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.

Trial Locations

Locations (1)

HealthPartners; 🇺🇸 Bloomington, Minnesota, United States