Evaluation of the First To Know Pregnancy Test for Self-Use in Women Ages 14 and Older Assessing Accuracy and Usability Across Pre-, Peri-, and Post-Menopausal Groups

What this Trial Is About

Researchers are evaluating the First To Know4 Pregnancy test, an investigational device adapted from the FDA-cleared ADEXUSDx4 hCG test, for potential over-the-counter use by lay users in a simulated home setting. The study involves females with unknown pregnancy status across different age groups, including pre-menopausal, peri-menopausal, and post-menopausal women, assessing how well the test performs compared to standard blood-based pregnancy tests. The study is organized into two cohorts Cohort A, which includes up to 100 pregnant participants divided into three age groups, will perform self-testing and provide blood samples for comparison with a reference method. Cohort B consists of a subset of Cohort A participants who will perform duplicate self-tests consecutively to evaluate the tests accuracy and precision. Participants will test themselves and interpret results independently without assistance. Participants will self-administer the pregnancy test and provide blood samples for comparison. Negative results will be followed up to confirm pregnancy status, and positive results will be verified using standard care data. The study will track outcomes over an average of six months, measuring the tests accuracy, sensitivity, specificity, usability, and precision in real-world conditions. Participants will also provide information about their pregnancy diagnosis from their healthcare providers follow-up visits.

First To Know Pregnancy Test - Clinical Evaluation Protocol