Strep A Fluorescent Immunoassay and Analyzer Field Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Strep Throat

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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In Vitro Diagnostic Device aid in diagnosing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects three (3) years of age or older

Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis

* Extreme sore throat
* Redness of the posterior pharyngeal wall
* Difficulty Swallowing
* Fever, \>38.7C (100F) at presentation or within past 24 hours
* Pharyngeal exudate
* Tender cervical lymphadenopathy
* Absence of cough or other upper respiratory symptoms

Exclusion Criteria

* Subjects currently under treatment with antibiotics are not to be included in this study.
* At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No