Sofia hCG FIA Field Study

March 11, 2013 updated by: Quidel Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

975

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Any female of childbearing potential being screened for pregnancy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quidel Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Estimate)

March 13, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CS-0144-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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