Hepatitis C Lab Testing Comparison Study

NCT06380166 | Terminated FDA Device

• 1 other identifier: A23-356
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

In vitro stability investigation

Diagnostic Test: Hepatitis C core antigen

Interventions

Hepatitis C core antigen DIAGNOSTIC_TEST

Semi-quantitative, automated immunoassay detecting core antigen of hepatitis C virus.

In vitro stability investigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have tested positive for Hepatitis C

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)

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners

Bloomington, Minnesota, 55425, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Participants will be asked to undergo a blood draw

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Scientific Medical Laboratory

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 23, 2024
• Study Start: July 24, 2024
• Primary Completion: August 20, 2024
• Study Completion: December 6, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

US (1)