Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center and provide a sample of urine from the same void for further testing. Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.
Eligible volunteers will be recruited into the study and provide informed consent. Volunteers will then test their urine sample with the investigational HPT according to the device Instructions For Use, and their results will be recorded. A sample of urine from the same void will be obtained for further testing by the healthcare provider (HCP) study technicians. The HCP technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires. True pregnancy status will be determined by laboratory tests and clinical information.
Study Type
OBSERVATIONAL
Enrollment
180
Multi-Level Pregnancy Test
Early Pregnancy Test
FPA Women's Health
Los Angeles, California, United States
Lay-Professional Comparison
Demonstration of agreement of pregnancy test reading. The agreement between lay participant test results and those of a technician testing the same urine sample.
Time frame: 1 day
Predicate Comparison
Demonstration of agreement of pregnancy test reading. The agreement between the predicate device and investigational device test results performed by a technician testing the same urine sample.
Time frame: 1 day
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