A Clinical Study to Evaluate the Clinical Performance of the SEQureDx Trisomy 21 Test in the Detection of the Relative Quantity of Chromosome 21 in Circulating Cell-Free DNA Extracted From a Maternal Blood Sample Obtained From Pregnant Women With One or More High Risk Indicators for Fetal Chromosome 21 Aneuploidy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,062
- 试验地点
- 28
- 主要终点
- Clinical Assay Performance
研究概览
简要总结
Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman 18 years of age or older at 10 - 22 weeks gestation inclusive
- •Subject has one or more high risk indicator for fetal chromosome 21 aneuploidy
- •Subject provides signed and dated informed consent
- •Subject agrees to provide a whole blood sample
排除标准
- •Fetal demise at the time of the blood draw
- •Previous specimen donation under this protocol
结局指标
主要结局
Clinical Assay Performance
时间窗: Performance of the assay will be based upon a single blood sample collected during the only study visit from a high risk pregnancy prior to the subject undergoing an invasive procedure (amniocentesis or CVS) to confirm fetal karyotype.
Each subject will provide a single blood sample prior to undergoing an amniocentesis/CVS that will be processed to plasma and stored frozen until the end of the study. Frozen plasma samples will then be analyzed using the SEQureDx Trisomy Test and the sensitivity and specificity of the assay will be determined by comparing the plasma test results to the fetal karyotyping results obtained via aminiocentesis or CVS. A subject's participation ends after the results of the fetal karyotype are obtained and recorded.
次要结局
- Subject selection bias assessment(A single blood sample will be collected at a single clinic visit from high risk pregnancies that refuse to undergo an invasive procedure.)