Clinical trial NCT06380166: Hepatitis C Lab Testing Comparison Study
Official title: Hepatitis C Lab Testing Comparison Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have tested positive for Hepatitis C

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Serum on the clot stability
timeFrame: 6 days
measure: Serum off the clot stability
timeFrame: 6 days
measure: Plasma on the gel stability
timeFrame: 6 days
measure: Plasma off the gel stability
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: HealthPartners
state: Minnesota
Study officials:
References: