Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23)

NCT06289868 | Completed

• 2 other identifiers: DC-TR23-0222HAV-EU-11-23
• Study Type: observational
• Target: 1,409
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and of the Access anti-HAV IgM assay as an aid in the laboratory diagnosis of acute or recent HAV infection, on the DxI 9000 Access Immunoassay Analyzer. This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays.

Conditions

HAV

Keywords

Hepatitis A Virus (HAV); IgM antibody to Hepatitis A Virus (HAV IgM); antibody to Hepatitis A Virus

Outcome Measures

Primary Outcomes (2)

• Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity

  The endpoints will be diagnostic accuracy measured as clinical sensitivity and specificity of Access anti-HAV assay compared to final anti-HAV status

  Baseline

• Access Anti-HAV IgM diagnostic accuracy measured as sensitivity and specificity

  The endpoints will be diagnostic accuracy measured as clinical sensitivity and specificity of Access anti-HAV IgM assay compared to final anti-HAV IgM status.

  Baseline

Study Arms (3)

At-risk and/or signs and symptoms patients of HAV infection and/or HAV test ordered patients

Frozen leftover serum samples from adult and pediatric patients: * From subjects exhibiting either jaundice or elevated total bilirubin or elevated serum ALT enzymes and one or more primary signs and symptoms of hepatitis infection, and/or * From subjects at-risk of HAV infection, and/or * From subjects for whom laboratory testing for hepatitis A was ordered by their healthcare providers.

Diagnostic Test: Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays

Known anti-HAV IgM positive patients

Frozen serum or EDTA retrospective known anti-HAV IgM positive leftover samples procured from sample vendors . These samples are known Positive for HAV IgM AND at least one of the following : * Positive HAV PCR result (within the last 28 days) OR * Jaundice (clinical assessment OR Total bilirubin result \>3.0 mg/dL) OR * Elevated ALT result (\> 200 IU/L)

Diagnostic Test: Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays

HAV Pre- and post-vaccinated patients

Frozen serum leftovers. A first sample was collected, and the US licensed and CE-marked vaccination series administered. A second sample was collected four (4) to ten (10) weeks after the complete vaccination series has been administered according to vaccine dosing instructions.

Diagnostic Test: Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays

Interventions

Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays DIAGNOSTIC_TEST

Samples will be tested by comparing Access anti-HAV assay results to final anti-HAV sample status, and Access anti-HAV IgM results to final anti-HAV IgM status, according to respective instructions for use (IFU) or study guide, as applicable, to determine to determine non-reactive (NR), reactive (R), Negative, Positive or Equivocal (EQ). For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT). For evaluation of the clinical performance of Access anti-HAV IgM assay, all clinical samples, except pre- and post-vaccinated patient samples, will be tested with the reference assays Abbott - ARCHITECT® HAVAb-IgM, DiaSorin - LIAISON® Anti-HAV IgM, and SIEMENS Healthineers Atellica IM® Hepatitis A IgM (aHAVM).

At-risk and/or signs and symptoms patients of HAV infection and/or HAV test ordered patients; Known anti-HAV IgM positive patients

Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays DIAGNOSTIC_TEST

All samples will be tested pre- and post-vaccination by comparing Access anti-HAV assay results to final anti-HAV status, according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT).

HAV Pre- and post-vaccinated patients

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population is the hepatitis A infection diagnostic population, and pre- and post-HAV vaccinated patients for Access anti-HAV assay only. Population will include approximately 1,030 subjects as follows: * ≥ 930 samples from adult and pediatric patients were collected as part of the US HAV trial prospective and retrospective sample enrollment : * From subjects exhibiting either jaundice or elevated bilirubin or elevated serum ALT enzymes and one or more primary signs and symptoms of hepatitis infection, and/or * From subjects at-risk of HAV infection, and/or * From subjects for whom laboratory testing for hepatitis A was ordered by their healthcare providers. * ≥ 100 retrospective known anti-HAV IgM positive samples. In addition, for the Access anti-HAV assay only, at least 60 subjects from the US vaccination study will be tested pre and post vaccination in this EU HAV assay clinical trial.

You may qualify if:

• Subjects ≥ 2 years of age
• Subject or legal guardian has signed the Informed Consent Form (ICF) (a minor may need to sign an Assent Form (AF) if required by IRB)
• Subjects who are willing to donate the required amount of blood
• Subjects qualified for one (1) or more of the following four (4) Cohorts:
• Signs and symptoms (S/S);
• At risk (A/R);
• Presumed S/S or A/R (HAV test ordered) and
• Acute HAV Infection (known anti-HAV IgM positive samples) - these samples are not subject to the individual informed consent and volume criteria.
• Subjects 2 years of age or older
• Subjects able to understand and willing to sign the ICF at both pre and post vaccination time points. Subject or legal guardian has signed the Informed Consent Form (a minor may need to sign an assent form if required by IRB)
• Subjects who are willing to donate the required amount of blood: 30 mL
• Subjects with no signs or symptoms of hepatitis as determined by a medical provider, no history of known exposure to HAV
• Subjects previously unvaccinated for HAV

You may not qualify if:

• Subjects who previously participated in the study
• Subjects who have received experimental or investigational drugs or treatments within four weeks of phlebotomy
• Note for vaccination study: Subjects were screened for anti-HAV prior to vaccination, if positive they were excluded from the study.

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (2)

Cerba Xpert

Frépillon, 95740, France

Location

Eurofins Biomnis

Ivry-sur-Seine, 94208, France

Location

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: February 27, 2024
• Primary Completion: August 13, 2024
• Study Completion: August 29, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)