Trials / Completed
CompletedNCT01803113
Sofia hCG FIA Field Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 975 (actual)
- Sponsor
- Quidel Corporation · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.
Detailed description
Subjects presenting for pregnancy testing will provide urine specimens that will be tested with the Sofia hCG FIA test and the comparator pregnancy test that will detect levels of hCG of 20mIU as positive for pregnancy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sofia hCG FIA | Qualitative detection via immunofluorescence technology of increased level of hCG present in urine. |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2013-03-04
- Last updated
- 2013-03-13
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01803113. Inclusion in this directory is not an endorsement.