First To Know Pregnancy Test - Clinical Evaluation Protocol

Overview

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.

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. Two (2) cohorts are planned to assess: Cohort A: Cross sectional cohort evaluating clinical performance with enrollment up to 100 pregnant subjects across three (3) age groups conducted at clinical sites. Tests will be read and interpreted by the lay user. Blood will be collected at the time of testing for comparator method testing. Positive test results will be confirmed by obtaining data from standard of care assessment(s) for diagnosis of pregnancy. Cohort A1: pre-menopausal women age 14-40 Cohort A2: peri-menopausal women age 41-55 Cohort A3: post-menopausal women age \>55 Cohort B: Duplicate testing cohort designed to evaluate accuracy and precision in lay users. A subset of a minimum of 100 participants from Cohort A will co-enroll into Cohort B and conduct duplicate testing using the First To Know® Pregnancy test. Participants will independently self-administer two tests consecutively and visually interpret the results without assistance. Enrollment will reflect the observed prevalence of positive and negative pregnancy results in Cohort A, ensuring adequate representation across all age cohorts (pre-menopausal, peri-menopausal, and post-menopausal). The results from the first test will be used to assess accuracy, while the second test will evaluate precision and agreement with the first test.

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Central Contacts