HAV
Conditions
Keywords
Hepatitis A Virus (HAV), IgM antibody to Hepatitis A Virus (HAV IgM), antibody to Hepatitis A Virus
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTAccess anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
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).
DIAGNOSTIC_TESTAccess anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
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).
Sponsors
Beckman Coulter, Inc.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity | Baseline | The endpoints will be diagnostic accuracy measured as clinical sensitivity and specificity of Access anti-HAV assay compared to final anti-HAV status |
| Access Anti-HAV IgM diagnostic accuracy measured as sensitivity and specificity | Baseline | 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. |
Countries
France
Outcome results
None listed