Pregnancy Detection
Conditions
Keywords
NOWDx First To Know Pregnancy Detection Test
Brief 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.
Detailed 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 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.
Interventions
DEVICEDiagnostic Test
For this observational trial , the Intervention of interest is the First To Know Pregnancy Test
Sponsors
NOWDiagnostics, Inc.
MCRA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First To Know Pregnancy test OTC evaluation | Through study completion, an average of 6 months | 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. |
Countries
United States
Outcome results
None listed