Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NOWDiagnostics, Inc.
With
MCRA
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.
Age
14–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
Males
Females \<14 years of age
People with limited or no reading skills
Clareo Health | First To Know Pregnancy Test - Clinical Evaluation Protocol
