Sofia hCG FIA Field Study

Quidel

Status: Completed

Conditions: Pregnancy, Early Detection

Treatments: Device: Sofia hCG FIA

Study type: Observational

Funder types: Industry

Identifiers

NCT01803113

CS-0144-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 975 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.