An observational study in Pregnancy, Early Detection, sponsored by Quidel Corporation. Completed at 5 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2013-03-13.
Sponsored by Quidel Corporation · Observational
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.
Quidel Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any female of childbearing potential being screened for pregnancy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Qualitative detection via immunofluorescence technology of increased level of hCG present in urine.
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
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Quidel Corporation