First To Know Pregnancy Test - Clinical Evaluation Protocol

NOWDiagnostics, Inc.892 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

892

Conditions

Pregnancy Detection

Interventions

Diagnostic TestDEVICE

For this observational trial , the Intervention of interest is the First To Know Pregnancy Test

Eligibility

Sex: FEMALEMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Males * Females \<14 years of age * People with limited or no reading skills

Locations (2)

Matrix Clinical Research Los Angeles

Los Angeles, California, United States

ERA Health Research

Midland, Texas, United States

Outcomes

Primary Outcomes

First To Know Pregnancy test OTC evaluation

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.

Time frame: Through study completion, an average of 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.