Strep A Fluorescent Immunoassay and Analyzer Field Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Quidel Corporation
ClinicalTrials.gov Identifier:
NCT01441479
First received: September 23, 2011
Last updated: February 5, 2013
Last verified: December 2012
  Purpose

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 Intervention
Strep Throat
Device: In Vitro Diagnostic Device aid in diagnosing

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Strep A Fluorescent Immunoassay and Analyzer Field Study

Resource links provided by NLM:


Further study details as provided by Quidel Corporation:

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


Enrollment: 1282
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Quidel Corporation
ClinicalTrials.gov Identifier: NCT01441479     History of Changes
Other Study ID Numbers: CS-0142-01
Study First Received: September 23, 2011
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Reagent Kits, Diagnostic
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014