Clara Pregnancy TestProfessional Marketed Pregnancy Test
Clara Pregnancy Test: Multi-Level Pregnancy Test
Professional Marketed Pregnancy Test: Early Pregnancy Test
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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