Sofia hCG FIA Field Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Quidel Corporation
ClinicalTrials.gov Identifier:
NCT01803113
First received: February 21, 2013
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Pregnancy, Early Detection
Device: Sofia hCG FIA

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Sofia hCG FIA Field Study

Resource links provided by NLM:


Further study details as provided by Quidel Corporation:

Primary Outcome Measures:
  • Determination of presence of hCG in urine [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Clinical performance will be based on comparison of Sofia hCG FIA test results to those obtained from an FDA-cleared hCG test.


Biospecimen Retention:   Samples Without DNA

Leftover urine specimens may be retained to be used for further product testing.


Enrollment: 975
Study Start Date: January 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Sofia hCG FIA
    Qualitative detection via immunofluorescence technology of increased level of hCG present in urine.
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any female of childbearing potential being screened for pregnancy

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803113

Locations
United States, Florida
Jose Castaneda, MD
Boynton Beach, Florida, United States, 33435-7959
United States, Massachusetts
New England Center for Clinical Research Fall River,LLC (NECCR)
Fall River, Massachusetts, United States, 02720
NECCR of Massachusetts, LLC
Fall River, Massachusetts, United States, 02720
United States, Rhode Island
Partners In Obstetrics and Gynecology, Inc.
Pawtucket, Rhode Island, United States, 02860
United States, Texas
Planned Parenthood Gulf Coast
Houston, Texas, United States, 77023
Sponsors and Collaborators
Quidel Corporation
  More Information

No publications provided

Responsible Party: Quidel Corporation
ClinicalTrials.gov Identifier: NCT01803113     History of Changes
Other Study ID Numbers: CS-0144-01
Study First Received: February 21, 2013
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Quidel Corporation:
Pregnancy
hCG

ClinicalTrials.gov processed this record on July 24, 2014