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Strep A Fluorescent Immunoassay and Analyzer Field Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01441479
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Strep Throat Device: In Vitro Diagnostic Device aid in diagnosing

Study Design

Study Type : Observational
Actual Enrollment : 1282 participants
Time Perspective: Prospective
Official Title: Strep A Fluorescent Immunoassay and Analyzer Field Study
Study Start Date : June 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Streptococcus Group B identification [ Time Frame: Immediate ]
    The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects must be greater than 3 years of age and exhibiting symptoms characteristic of pharyngitis, possibly Group A Streptococcus.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441479


Locations
United States, Arizona
Best Medical Group
Phoenix, Arizona, United States, 85042
United States, California
La Costa Pediatrics
Carlsbad, California, United States, 92009
La Jolla Pediatrics
San Diego, California, United States, 92121
United States, Florida
Teena Hughes
Tampa, Florida, United States, 33613
United States, New Jersey
FastER Urgent Care
Morris Plains, New Jersey, United States, 07950
United States, New York
Twelve Corners Pediatrics
Rochester, New York, United States, 14618
United States, Virginia
Advanced Pediatrics
Vienna, Virginia, United States, 22180
Sponsors and Collaborators
Quidel Corporation
More Information

Responsible Party: Quidel Corporation
ClinicalTrials.gov Identifier: NCT01441479     History of Changes
Other Study ID Numbers: CS-0142-01
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: December 2012