Hepatitis C Lab Testing Comparison Study

Hepatitis C Clinical Trial

Official title:

Hepatitis C Lab Testing Comparison Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380166
• Other study ID #: A23-356
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: HealthPartners Institute
• Contact: Ian Gunsolus
• Phone: 952-993-5303
• Email: ian.l.gunsolus[@]healthpartners.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Diagnostic Test:
• Hepatitis C core antigen
Semi-quantitative, automated immunoassay detecting core antigen of hepatitis C virus.

Locations

Country	Name	City	State
United States	HealthPartners	Bloomington	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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