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.

Study Overview

• Status: Completed
• Conditions: Strep Throat
• Intervention / Treatment: Device: In Vitro Diagnostic Device aid in diagnosing

• Study Type: Observational
• Enrollment (Actual): 1282

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Streptococcus Group B identification	The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done.	Immediate

Collaborators and Investigators

• Sponsor: Quidel Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimate): September 27, 2011

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 5, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections
• Other Study ID Numbers: CS-0142-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No