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Core Antigen Test for Hepatitis C

N/A
Recruiting
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 days
Awards & highlights

Summary

This trial aims to study the stability of a new test called HCV core antigen in blood samples from people with hepatitis C virus (HCV). This test is faster than the current standard test, polymer

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves standard blood draws and laboratory testing without direct medical interventions, typical side effects may include minor pain or bruising at the needle insertion site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma off the gel stability
Plasma on the gel stability
Serum off the clot stability
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: In vitro stability investigationExperimental Treatment1 Intervention

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Who is running the clinical trial?

HealthPartners InstituteLead Sponsor
191 Previous Clinical Trials
3,721,632 Total Patients Enrolled
~8 spots leftby Nov 2024
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