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Strep A Fluorescent Immunoassay and Analyzer Field Study
NCT01441479 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.
Conditions Studied
Interventions
- DEVICE In Vitro Diagnostic Device aid in diagnosing
Study Locations (7)
California
- La Costa Pediatrics — Carlsbad
- La Jolla Pediatrics — San Diego
Arizona
- Best Medical Group — Phoenix
Florida
- Teena Hughes — Tampa
New Jersey
- FastER Urgent Care — Morris Plains
New York
- Twelve Corners Pediatrics — Rochester
Virginia
- Advanced Pediatrics — Vienna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,282 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01441479
The ClinicalTrials.gov registry entry for NCT01441479 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Quidel Corporation, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Strep Throat appearing as the primary indexed condition, and to 1 intervention — of which In Vitro Diagnostic Device aid in diagnosing is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01441479 reports 7 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01441479 about?
NCT01441479 is a clinical study titled "Strep A Fluorescent Immunoassay and Analyzer Field Study". The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.
What is the current status of trial NCT01441479?
This trial is currently completed. The enrollment target is 1,282 participants. The study started on 2011-06. Estimated completion is 2012-12.
What conditions does trial NCT01441479 study?
This clinical trial studies the following conditions: Strep Throat. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01441479?
The interventions under investigation include: In Vitro Diagnostic Device aid in diagnosing (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01441479?
This trial is sponsored by Quidel Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01441479 being conducted?
This trial has 7 study locations across Arizona, California, Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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