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

Evaluation of the Access Anti-HAV and Access Anti-HAV IgM Assays As an Aid in the Diagnosis of HAV Infection, and for Detection of Anti-HAV After Vaccination: EU Clinical Trial Protocol

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.

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.

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 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.

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 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

Exclusion Criteria:

• 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.