Pregnancy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEClara Pregnancy Test
Multi-Level Pregnancy Test
DEVICEProfessional Marketed Pregnancy Test
Early Pregnancy Test
Sponsors
Conceptra Biosciences, LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Females (persons assigned female at birth and not sterile) willing and able to provide written consent to Study participation * Able to read and write in English or Spanish
Exclusion criteria
* Persons employed in a healthcare or laboratory setting and/or with professional experience who conduct point of care urine tests * Previous or current enrollment in a Clara™ Study * Visually or otherwise impaired to a degree they are not able to readily read and follow instructions, or visualize the faint pink lines. * Unwilling or unable to provide at least 12mls of urine specimen and any urine testing they are expected to receive as a part of their non-Study related care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lay-Professional Comparison | 1 day | Demonstration of agreement of pregnancy test reading. The agreement between lay participant test results and those of a technician testing the same urine sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predicate Comparison | 1 day | 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. |
Countries
United States
Contacts
CONTACTRegulatory Conceptra
Outcome results
None listed