First To Know Pregnancy Test Clinical Evaluation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 892
- 试验地点
- 4
- 主要终点
- First To Know Pregnancy test OTC evaluation
研究概览
简要总结
This study is evaluating the ADEXUSDx® hCG CLIA moderately complex, FDA-cleared test for potential over the counter (OTC) use and marketing as the First To Know® (FTK) Pregnancy test. The investigational FTK Pregnancy test will be used to assess its clinical performance in the intended use population (i.e., lay users) through self-testing in a simulated home setting.
详细描述
The Investigational First to Know® Pregnancy test has been adapted from the CLIA moderately complex, FDA-cleared ADEXUSDx® hCG test for clinical evaluation to enable lay users to self-test in a simulated home environment in the US. The First To Know® Pregnancy test is currently CE marked in the EU for OTC use. The assays remain identical in their formulation and performance characteristics.
The clinical evaluation includes lay users self-testing and additional blood being drawn for comparator testing. All negative test results will be followed up for outcome. All subjects with positive test results or reporting negative results later resulted in pregnancy will be confirmed by obtaining data from standard of care assessment(s) for diagnosis of pregnancy.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females whose pregnancy status is unknown (e.g., have not used urine test at home)
- •Not menstruating at the time of the initial study visit
- •Must be willing to complete all study activities, provide all specimens/samples, and conduct all required testing
- •Willing to provide information regarding the diagnosis of pregnancy or details from their standard of care follow-up visit after initial visit
- •Sexually active
- •Not using contraceptives
- •English/Spanish speaking
排除标准
- •Females <14 years of age
- •People with limited or no reading skills
研究组 & 干预措施
Cohort A: Women of unknown pregnancy status
Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, and from different age groups.
干预措施: Diagnostic Test (Device)
Cohort B: Duplicate Testing Cohort
Subset of Cohort A will be enrolled for duplicate testing.
干预措施: Diagnostic Test (Device)
结局指标
主要结局
First To Know Pregnancy test OTC evaluation
时间窗: Through study completion, an average of 6 months
Evaluate the accuracy and sensitivity of the First To Know Pregnancy test in an OTC setting compared to a legally marketed quantitative blood-based hCG assay as the clinical comparator.
Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay
时间窗: Through study completion, an average of 6 months
Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay (e.g., Siemens Dimension® hCG Flex® Reagent Cartridge, Roche Cobas® Elecsys HCG STAT) as the clinical comparator
次要结局
- Assess the performance of the FTK Pregnancy test near the cutoff range(Through study completion, an average of six months)
- Evaluate the test's specificity in pre-menopausal, peri-menopausal and post-menopausal women(through study completion, an average of 6 months)
- Evaluate testing precision(through study completion, an average of 6 months)
- Follow subjects to confirm pregnancy status(through study completion, an average of 6 months)
- Evaluate lay user performance under real-world conditions(through study completion, an average of 6 months)
- Assess the usability of the test(through study completion, an average of 6 months)