Core Antigen Test for Hepatitis C

Overseen By Ian Gunsolus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Age <18, Research opt-out, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to quickly confirm active Hepatitis C infections. Current methods can take days, potentially delaying treatment for those in need. The new test detects a protein linked to the virus, specifically the Hepatitis C core antigen, and aims to deliver results in just 48 hours. Individuals who recently tested positive for Hepatitis C and can undergo a follow-up blood draw within three weeks may be suitable for this trial.

As a Phase 2 trial, the study measures the effectiveness of the new test in an initial, smaller group, offering participants a chance to contribute to important research.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this core antigen test is safe for use?

Research has shown that the Hepatitis C core antigen test is generally easy for people to handle. This test detects a specific part of the Hepatitis C virus and identifies infections faster than some other tests. Conducted in a lab, it does not involve any medicine or treatments that affect the whole body.

No safety concerns have been reported with this type of test. Since these tests do not interact directly with the body, they are considered safe. Machines used for these tests, such as the Abbott Alinity i system, have FDA approval, indicating they meet certain safety standards.

Overall, for those considering joining a trial using this test, the risk to safety is very low. The test aims to improve the speed and accuracy of Hepatitis C detection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Hepatitis C core antigen test is unique because it offers a different approach to diagnosing Hepatitis C compared to the standard antibody tests. Most current tests detect antibodies, which can take weeks to develop after infection, potentially delaying diagnosis. This new test targets the core antigen, a part of the virus itself, allowing for the possibility of detecting the infection earlier. Researchers are excited about this because earlier detection can lead to faster treatment and potentially better outcomes for patients.

What evidence suggests that this core antigen test is effective for detecting Hepatitis C?

Research shows that the Hepatitis C core antigen test, investigated in this trial, effectively diagnoses Hepatitis C. Studies have found that this test correctly identifies people with the disease 87.1% to 100% of the time. One study reported it was 91% accurate in detecting the disease and 99% accurate in confirming those without it. This indicates the test's strong ability to determine Hepatitis C presence. Another review found that this test can match the accuracy of more complex tests like NAT (nucleic acid testing) for detecting active infections. These findings suggest the test is reliable and provides quick results. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can understand and agree to the study's details.

My Hepatitis C virus levels are detectable.

I had my initial hepatitis C test at a HealthPartners lab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Sample Collection and Testing

Participants with a recent positive HCV viral load test have additional blood drawn for HCV core antigen testing. Stability of the antigen is tested under various conditions.

6 days

Follow-up

Participants are monitored for safety and effectiveness after sample collection and testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hepatitis C core antigen

Trial Overview 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.

How Is the Trial Designed?

Group I: In vitro stability investigation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12531625/

HCV Core Antigen Diagnostic Performance for Acute ... The sensitivity of the HCVcAg test in the diagnosis of acute or recent HCV infection across the 4 included studies ranged from 87.1% to 100%, ...

2. idpjournal.biomedcentral.com idpjournal.biomedcentral.com/articles/10.1186/s40249-024-01264-7

Diagnostic performance of hepatitis C virus core antigen ... Our findings demonstrate that the Abbott ARCHITECT HCV Ag assay exhibits high accuracy (sensitivity 91%, specificity 99%) and excellent ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5345254/

HCV Core Antigen Testing for Diagnosis of HCV Infection This systematic review concludes that a well-performing HCVcAg test can achieve similar diagnostic accuracy to NAT for identification of active HCV infection ...

4. journals.asm.org journals.asm.org/doi/10.1128/jcm.01331-22

Diagnostic Performance of the HCV Core Antigen Test To ... In conclusion, the accuracy of the Abbott ARCHITECT HCV Ag assay was very good for HCV screening in serum/plasma samples from PLWHA. The ...

5. journals.lww.com journals.lww.com/ajg/fulltext/2024/10001/s1855_diagnostic_accuracy_of_hcv_core_antigen.1856.aspx

S1855 Diagnostic Accuracy of HCV Core Antigen Testing in... Results: The pooled sensitivity of HCVcAg was 95% (95% CI: 86%-98%) with significant heterogeneity (I 2 = 90%). The pooled specificity was 98% (95% CI: 97%-99%) ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190011B.pdf

summary of safety and effectiveness data (ssed) There are currently several FDA approved in vitro diagnostic tests commercially available for serological markers of hepatitis C virus (HCV) ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf8/P080027b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The data from the stability study for the OraQuick® HCV Rapid Antibody Test Kit Controls substantiates a twelve (12) month shelf life at storage conditions of ...

8. extranet.who.int extranet.who.int/prequal/sites/default/files/whopr_files/PQDx_0374-130-00_ARCHITECT-HCV_v1.0.pdf

ARCHITECT HCV Ag assay WHO reference number: PQDx ... The ARCHITECT HCV Ag assay is a two-step immunoassay for the quantitative determination of core antigen of Hepatitis C virus using CMIA ...

9. hepatitisc.uw.edu hepatitisc.uw.edu/go/screening-diagnosis/diagnostic-testing/core-concept/all

Core Concepts - Hepatitis C Diagnostic Testing Sensitivity of EIA and False-Negative Results: The third-generation HCV EIA has a sensitivity of approximately 98%.[8,9,10] Circumstances ...

10. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf9/P090009b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Elecsys Anti-HCV assay is an in vitro diagnostic test for the qualitative detection of total antibodies to hepatitis C virus (anti-HCV) in human serum ...