Alinity s Anti-HCV II - Clinical Evaluation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16,388
- 试验地点
- 8
- 主要终点
- Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay.
研究概览
简要总结
The objective of this study is to demonstrate the performance and intended use of the Alinity s Anti-HCV II investigational assay in a donor screening environment using clinical samples to evaluate assay performance. The Alinity s Anti-HCV II assay performance will be evaluated utilizing the Food and Drug Administration (FDA) licensed Alinity s Anti-HCV assay as the comparator method. The data will be used to support regulatory submissions and/or publications.
详细描述
This study evaluates the Alinity s Anti-HCV II investigational assay using the Alinity s System.
The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System. The Alinity s Anti-HCV II assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV.
The performance of the Alinity s Anti-HCV II assay will be evaluated by performing specificity, and sensitivity testing of the Alinity s Anti-HCV II assay.
To evaluate specificity, approximately 15,000 random unique donor specimens will be collected.
To evaluate sensitivity, Abbott will provide a minimum of 400 frozen samples from U.S. individuals characterized as HCV positive and a minimum of 400 frozen specimens from U.S. individuals at increased risk for HCV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.
排除标准
- •Previous participation in this study. Each subject must be represented only once in the study.
- •Note: Frozen samples (sensitivity) provided by Abbott (403 specimens characterized as positive for HCV and 404 specimens with Increased risk of HCV infection) have no specific inclusion/exclusion criteria that the clinical sites need to verify prior to testing. Inclusion and exclusion criteria only apply to specificity specimens.
结局指标
主要结局
Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay.
时间窗: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
A total of 15,526 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with the investigational Alinity s Anti-HCV II assay. Repeatedly reactive specimens were tested further with supplemental assays, if required, to determine final status. Anti-HCV II Repeatedly Reactive, Final Status Indeterminate = B Anti-HCV II Repeatedly Reactive, Final Status Negative = C Anti-HCV II Nonreactive, Final Status Negative = F Specificity is calculated as the proportion of nonreactive specimens from specimens with negative status: F / (C+F) × 100% Specificity can be also calculated as the proportion of nonreactive specimens with negative status from specimens with negative status and repeatedly reactive specimens with indeterminate status: F / (C + B + F) × 100%
Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay.
时间窗: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
A total of 403 specimens characterized as positive for HCV were obtained from specimen vendors and tested with the investigational Alinity s Anti-HCV II assay. Anti-HCV II Repeatedly Reactive, Final Status Positive = A Anti-HCV II Nonreactive, Final Status Positive = D Anti-HCV II Nonreactive, Final Status Indeterminate = E Sensitivity is calculated as the proportion of repeatedly reactive specimens from specimens with positive final status: A / (A+D) × 100% Sensitivity can also be calculated as the proportion of repeatedly reactive specimens with positive status from specimens with positive status and nonreactive specimens with indeterminate status: A / (A + D + E) × 100%
次要结局
- Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay.(Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.)