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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay
Timeframe: Through study completion, an average of 6 months