Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106,881
- 试验地点
- 10
- 主要终点
- Alinity s Anti-HCV Assay Specificity
研究概览
简要总结
The objective of this study is to demonstrate the performance and intended use of each of the Alinity s investigational assays in a donor screening environment using clinical specimens to evaluate assay performance characteristics. A comparison of assay performance will be done versus the Food and Drug Administration (FDA) licensed assays. The data will be used to support regulatory submissions and/or publications.
详细描述
This study evaluates Alinity s investigational assays using the Alinity s System. The Alinity s System is a high-volume, automated, blood-screening analyzer that is designed to determine the presence of specific antigens and antibodies by using chemiluminescent microparticle immunoassay (CMIA) detection technology. The system performs high-throughput routine and stat processing that features continuous access and automated retesting.
The Alinity s System is used for infectious disease marker testing in blood-screening and plasma laboratories for the following assays: Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory and HIV Ag/Ab Combo.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy donors who consented to participate in the study.
排除标准
- •For testing with the Alinity s Chagas assay, exclude donors that have been screened on a previous donation using a licensed test for antibodies to T cruzi.
- •Note: A subject may participate at different times during the study for separate assay studies, but each subject should be represented only once for each assay.
- •The protocol does not define an age limit. A donor must be at least 17 years old to donate to the general blood supply, or 16 years old with parental/guardian consent, if allowed by state law.
研究组 & 干预措施
Screening
All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.
干预措施: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay (Device)
Screening
All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.
干预措施: Alinity s HTLV I/II Assay (Device)
Screening
All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.
干预措施: Alinity s Anti-HCV Assay (Device)
Screening
All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.
干预措施: Alinity s HIV Ag/Ab Combo Assay (Device)
Screening
All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.
干预措施: Alinity s Anti-HBc Assay (Device)
Screening
All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.
干预措施: Alinity s Chagas Assay (Device)
结局指标
主要结局
Alinity s Anti-HCV Assay Specificity
时间窗: 10 months
Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.
Alinity s HBsAg Assay Specificity
时间窗: 10 months
Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.
Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity
时间窗: 10 months
Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.
Alinity s HTLV I/II Assay Specificity
时间窗: 10 months
Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.
Alinity s HTLV I/II Assay Sensitivity
时间窗: 10 months
Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following: Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100
Alinity s Anti-HCV Assay Sensitivity
时间窗: 10 months
Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.
Alinity s HIV Ag/Ab Combo Assay Specificity
时间窗: 10 months
Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
Alinity s HIV Ag/Ab Combo Assay Sensitivity
时间窗: 10 months
Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.
Alinity s Anti-HBc Assay Specificity
时间窗: 10 months
Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
Alinity s Anti-HBc Assay Sensitivity
时间窗: 10 months
Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following: Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279
Alinity s Chagas Assay Specificity
时间窗: 10 months
Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.
Alinity s Chagas Assay Sensitivity
时间窗: 10 months
Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.
次要结局
- Alinity s HBsAg Assay Increased Risk of HBV Infection(10 months)
- Alinity s HBsAg Assay Recovered HBV Infection(10 months)
- Alinity s HTLV Assay Increased Risk of HTLV Infection(10 months)
- Alinity s HTLV I/II Assay Endemics(10 months)
- Alinity s Anti-HCV Assay Increased Risk for HCV(10 months)
- Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2(10 months)
- Alinity s HIV Ag/Ab Combo Assay Endemics(10 months)
- Alinity s Anti-HBc Assay Increased Risk for HBV(10 months)
- Alinity s Chagas Assay Endemics(10 months)