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Completed

NCT Number: NCT01803113

Sofia hCG FIA Field Study

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.

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Key information

Conditions

Pregnancy, Early Detection

Sex eligibility

Female

Study type

Observational

Primary location

Jose Castaneda, MD, Boynton Beach, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sofia hCG FIA

Device

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Quidel Corporation

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2013
Registry last updated
Mar 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.