Status:
COMPLETED
Sofia hCG FIA Field Study
Lead Sponsor:
Quidel Corporation
Conditions:
Pregnancy, Early Detection
Eligibility:
FEMALE
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 posi...
Eligibility Criteria
Inclusion
- Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
975 Patients enrolled
Trial Details
Trial ID
NCT01803113
Start Date
January 1 2013
End Date
March 1 2013
Last Update
March 13 2013
Active Locations (5)
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1
Jose Castaneda, MD
Boynton Beach, Florida, United States, 33435-7959
2
NECCR of Massachusetts, LLC
Fall River, Massachusetts, United States, 02720
3
New England Center for Clinical Research Fall River,LLC (NECCR)
Fall River, Massachusetts, United States, 02720
4
Partners In Obstetrics and Gynecology, Inc.
Pawtucket, Rhode Island, United States, 02860