Sofia hCG FIA Field Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01803113
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : March 13, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pregnancy, Early Detection Device: Sofia hCG FIA

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 Type : Observational
Actual Enrollment : 975 participants
Time Perspective: Prospective
Official Title: Sofia hCG FIA Field Study
Study Start Date : January 2013
Primary Completion Date : March 2013
Study Completion Date : March 2013

Intervention Details:
    Device: Sofia hCG FIA
    Qualitative detection via immunofluorescence technology of increased level of hCG present in urine.

Primary Outcome Measures :
  1. Determination of presence of hCG in urine [ Time Frame: 1 day ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any female of childbearing potential being screened for pregnancy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01803113

United States, Florida
Jose Castaneda, MD
Boynton Beach, Florida, United States, 33435-7959
United States, Massachusetts
NECCR of Massachusetts, LLC
Fall River, Massachusetts, United States, 02720
New England Center for Clinical Research Fall River,LLC (NECCR)
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

Responsible Party: Quidel Corporation Identifier: NCT01803113     History of Changes
Other Study ID Numbers: CS-0144-01
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013

Keywords provided by Quidel Corporation: