Sofia hCG FIA Field Study

Completed

• Conditions: Pregnancy, Early Detection

• Registration Number: NCT01803113
• Lead Sponsor: Quidel Corporation

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-21
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 975

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

NECCR of Massachusetts, LLC; 🇺🇸 Fall River, Massachusetts, United States

Jose Castaneda, MD; 🇺🇸 Boynton Beach, Florida, United States

New England Center for Clinical Research Fall River,LLC (NECCR); 🇺🇸 Fall River, Massachusetts, United States

Partners In Obstetrics and Gynecology, Inc.; 🇺🇸 Pawtucket, Rhode Island, United States

Planned Parenthood Gulf Coast; 🇺🇸 Houston, Texas, United States