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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,409
- 试验地点
- 2
- 主要终点
- Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点