This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to: 1. Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG. 2. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test. 3. Assess user comprehension of the pregnancy test, especially assessment of the result.
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to: 1. Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG. 2. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test. 3. Assess user comprehension of the pregnancy test, especially assessment of the result.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
Planned Parenthood Mar Monte
Sacromento, California, United States
Stanford University School of Medicine
Stanford, California, United States
Family Planning Associates Medical
Chicago, Illinois, United States
To assess the correlation between this pregnancy test's results with serum values (as distinct from urine) hCG. 2. To assess whether or not urine concentration has any impact on the outcome
Time frame: 15 minutes pregnancy test reading
To assess user comprehension of the test.
Time frame: study duration
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