Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- congruence of Toxoplasma ICT IgG-IgM test and standard predicate test
研究概览
简要总结
This is part of a feasibility study to compare the predicate standard FDA cleared test for serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The specificity and sensitivity in testing serum and whole blood will be compared. This study includes 70 persons either pregnant or non pregnant.
This is being done in accordance with FDA requirements for clearance of a testing device . The investigators will use a standard FDA cleared test in all studies. The FDA has suggested that the investigators submit a pre subQ for a 510K and dual CLIA waiver.
This allows the investigators also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.
详细描述
This study will determine the feasibility of using the point of care Toxoplasma ICT IgG-IgM BK test produced by LD Bio Diagnostic to detect Toxoplasma gondii in clinical settings. The result of testing from Toxoplasma ICT IgG-IgM BK test will be compared with the standard predicate test. These results will be provided to FDA for consideration for clearance of this test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •any adult who is willing to participate in the study
排除标准
- •pregnant women who are in their 17-27 weeks of gestation.
结局指标
主要结局
congruence of Toxoplasma ICT IgG-IgM test and standard predicate test
时间窗: two weeks for initial result and a year for whole study
Toxoplasma ICT IgG-IgM test is feasible and the test result of the study device is same with the result of standard cleared test
次要结局
未报告次要终点