Sofia hCG FIA Field Study

Quidel Corporation975 enrolled

Overview

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.

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

975

Conditions

Pregnancy, Early Detection

Interventions

Sofia hCG FIADEVICE

Qualitative detection via immunofluorescence technology of increased level of hCG present in urine.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (5)

Jose Castaneda, MD

Boynton Beach, Florida, United States

NECCR of Massachusetts, LLC

Fall River, Massachusetts, 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

Outcomes

Primary Outcomes

Determination of presence of hCG in urine

Clinical performance will be based on comparison of Sofia hCG FIA test results to those obtained from an FDA-cleared hCG test.

Time frame: 1 day

Data from ClinicalTrials.gov

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