First To Know Pregnancy Test Clinical Evaluation Protocol
NOWDiagnostics, Inc.
Summary
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.
Description
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 r…
Eligibility
- Age range
- 14+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Females whose pregnancy status is unknown (e.g., have not used urine test at home) * Age Selection - must meet one of the following age groups: * Cohort A1 - Pre-menopausal: ≥14 years of age and ≤ 40 years of age with menstrual cycles (cycle lengths of 25-35 days) * Cohort A2 - Peri-menopausal: ≥41 years of age and ≤ 54 years of age * Cohort A3 - Post-menopausal: ≥55 years of age * 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…
Interventions
- DeviceDiagnostic Test
For this observational trial , the Intervention of interest is the First To Know Pregnancy Test
Locations (2)
- Matrix Clinical Research Los AngelesLos Angeles, California
- ERA Health ResearchMidland, Texas