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:
- Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
- Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
- Assess user comprehension of the pregnancy test, especially assessment of the result.
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess user comprehension of the test. [ Time Frame: study duration ] [ Designated as safety issue: No ]
| Enrollment: |
400 |
| Study Start Date: |
November 2008 |
| Study Completion Date: |
September 2009 |
| Primary Completion Date: |
September 2009 (Final data collection date for primary outcome measure) |
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:
- Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
- Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
- Assess user comprehension of the pregnancy test, especially assessment of the result.
Purpose
