Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA CENTAUR® PREGNANCY ASSOCIATED PLASMA PROTEIN A and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin ASSAYS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sample handling
研究概览
简要总结
Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.
详细描述
Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required.
Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:
- •Subject is ≥ 18 years of age
- •Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent.
- •Women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm
排除标准
- •A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment:
- •Subject is unable to give consent
- •Subject has already participated in the study
结局指标
主要结局
Sample handling
时间窗: 3 months
Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test.
次要结局
未报告次要终点