Pregnancy, Early Detection
Conditions
Keywords
Pregnancy, hCG
Brief 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.
Interventions
DEVICESofia hCG FIA
Qualitative detection via immunofluorescence technology of increased level of hCG present in urine.
Sponsors
Quidel Corporation
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent
Exclusion criteria
* Subject is post-menopausal. * Subject within the past six weeks has experienced any of the following: delivered a newborn; had an abortion or a natural termination (miscarriage); or, received hCG supplements. * Subject has had a hysterectomy. * Unable to understand and consent to participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of presence of hCG in urine | 1 day | Clinical performance will be based on comparison of Sofia hCG FIA test results to those obtained from an FDA-cleared hCG test. |
Countries
United States
Outcome results
None listed