Phase
Condition
N/ATreatment
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
Ages > 2 All Genders
Study Summary
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
Study Description
Connect with a study center
Cerba Xpert
Frepillon, 95740
FranceSite Not Available
Eurofins Biomnis
Ivry-sur-Seine, 94208
FranceSite Not Available
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