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Completed No phase listed Observational

Sofia hCG FIA Field Study

ClinicalTrials.gov ID: NCT01803113

Public ClinicalTrials.gov record NCT01803113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 4, 2026, 12:10 PM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01803113
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Quidel Corporation
Industry
Enrollment
975 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
Not listed
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2013 (Type not available)
Primary completion
Mar 2013 (Actual)
Completion
Mar 2013 (Actual)
Last update posted
Mar 13, 2013

2013

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Jose Castaneda, MD Boynton Beach Florida 33435-7959 —
NECCR of Massachusetts, LLC Fall River Massachusetts 02720 —
New England Center for Clinical Research Fall River,LLC (NECCR) Fall River Massachusetts 02720 —
Partners In Obstetrics and Gynecology, Inc. Pawtucket Rhode Island 02860 —
Planned Parenthood Gulf Coast Houston Texas 77023 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01803113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 13, 2013 · Synced Nov 4, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01803113 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →