NCT01803113已完成不适用
Sofia hCG FIA Field Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 975
- 试验地点
- 5
- 主要终点
- Determination of presence of hCG in urine
研究概览
简要总结
The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.
详细描述
Subjects presenting for pregnancy testing will provide urine specimens that will be tested with the Sofia hCG FIA test and the comparator pregnancy test that will detect levels of hCG of 20mIU as positive for pregnancy.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent
排除标准
- •Subject is post-menopausal.
- •Subject within the past six weeks has experienced any of the following: delivered a newborn; had an abortion or a natural termination (miscarriage); or, received hCG supplements.
- •Subject has had a hysterectomy.
- •Unable to understand and consent to participation.
结局指标
主要结局
Determination of presence of hCG in urine
时间窗: 1 day
Clinical performance will be based on comparison of Sofia hCG FIA test results to those obtained from an FDA-cleared hCG test.
次要结局
未报告次要终点
研究者
研究点 (5)
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