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

Last updated: December 2, 2024
Sponsor: Beckman Coulter, Inc.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

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

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

Clinical Study ID

NCT06289868
DC-TR23-0222
HAV-EU-11-23
  • Ages > 2
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subject inclusion criteria for the signs and symptoms (S/S), at risk (A/R), HAV test ordered, and Acute HAV Infection cohorts:

  • Subjects ≥ 2 years of age

  • Subject or legal guardian has signed the Informed Consent Form (ICF) (a minor mayneed 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 arenot subject to the individual informed consent and volume criteria.

Subject inclusion criteria for the vaccination cohort

  • Subjects 2 years of age or older

  • Subjects able to understand and willing to sign the ICF at both pre and postvaccination time points. Subject or legal guardian has signed the Informed ConsentForm (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

Exclusion

Exclusion Criteria:

  • Subjects who previously participated in the study

  • Subjects who have received experimental or investigational drugs or treatmentswithin 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.

Study Design

Total Participants: 1409
Treatment Group(s): 2
Primary Treatment: Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
Phase:
Study Start date:
February 27, 2024
Estimated Completion Date:
August 29, 2024

Study Description

The objective of this study is to determine the diagnostic accuracy of Access anti-HAV and Access anti-HAV IgM assays on the DxI 9000 Access Immunoassay Analyzer, measured as clinical sensitivity and specificity.

The testing will be performed using banked, de-identified, prospective and retrospective US leftover clinical samples, and fully-anonymized retrospective known anti-HAV IgM positive patient samples procured from sample vendors.

Connect with a study center

  • Cerba Xpert

    Frepillon, 95740
    France

    Site Not Available

  • Eurofins Biomnis

    Ivry-sur-Seine, 94208
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.