Blood Donation Screening for Babesia Microti by Real-time Polymerase Chain Reaction (PCR) and by Indirect Flourescent Antibody (IFA) Assays
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90,116
- 试验地点
- 2
- 主要终点
- number of blood donors testing positive for evidence of Babesia infection
研究概览
简要总结
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection.
Two laboratory methodologies will be utilized:
-
- PCR, to look for the presence of B.microti in whole blood
-
- IFA, to look for significant titers of B.microti antibody
详细描述
Retrospective study will involve archived specimens from blood donors whose units have already been released and transfused into recipients.
Prospective study will be real time and units testing positive by either PCR or IFA will be not released and will be disgarded, and the donors advised and deferred from further blood donation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •same as for donating blood
排除标准
- •donor refusual to sign informed consent for this investigational babesia testing
研究组 & 干预措施
retrospective
archived specimens from blood donors whose units have already been released and transfused into recipients will be tested. Attempts will be made to contact and obtain follow up specimens from both the donor and recipient of units initially testing positive for B.microti. the interventions are investigational diagnostic tests for B.microti (PCR and IFA).
干预措施: B.microti diagnostic blood tests (Biological)
prospective, real time
specimens from current blood donors will be tested and those testing positive for B.microti will not be released and the units will be disgarded, and the donors notified and deferred from future blood donation. the interventions are investigational diagnostic tests for B.microti (PCR and IFA).
干预措施: B.microti diagnostic blood tests (Biological)
结局指标
主要结局
number of blood donors testing positive for evidence of Babesia infection
时间窗: goal is up to one year (all specimens by end 2012)
次要结局
- the number of cases of transfusion transmitted babesia infection identified(goal is up to one year (all specimens by end 2012))