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Sofia Strep A FIA 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. Identifier: NCT01494792
Recruitment Status : Terminated (Performance did not meet sponsor requirements.)
First Posted : December 19, 2011
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):
Quidel Corporation

Brief Summary:
The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.

Condition or disease Intervention/treatment
Group A Streptococcus Strep Throat Device: In Vitro Diagnositc aid for diagnosis

Study Type : Observational
Actual Enrollment : 2090 participants
Time Perspective: Prospective
Official Title: Sofia Strep A FIA Field Study
Study Start Date : November 2011
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 three (3) years of age or older and exhibiting symptoms characteristics of pharyngitis, possibly Group A Streptococcus.

Inclusion Criteria:

  • Presence of sore throat
  • Redness of the posterior pharyngeal wall
  • Tonsillar exudate
  • Tonsillar swelling
  • Tender anterior cervical adenopathy
  • Fever, > 38º C (100.4ºF) at presentation or within past 24 hours

Other symptoms that may be present, in addition to above symptoms for GAS:

  • Rash, typical of scarlet fever
  • Abnormal tympanic membranes
  • Palatal petechiae

Exclusion Criteria:

  • Subjects treated with antibiotics currently or within the previous week (7 days) 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.

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 identifier (NCT number): NCT01494792

United States, California
La Costa Pediatrics
Carlsbad, California, United States, 92009
Santo Nino Medical Clinic
Panorama City, California, United States, 91402
La Jolla Pediatrics
San Diego, California, United States, 92121
United States, Florida
Teena Hughes, MD
Tampa, Florida, United States, 33613
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614-3394
United States, New York
Twelve Corners Pediatrics
Rochester, New York, United States, 14618
United States, Ohio
Montrose Family Practice
Akron, Ohio, United States, 44333
United States, Virginia
Advanced Pediatrics
Vienna, Virginia, United States, 22180
Sponsors and Collaborators
Quidel Corporation

Responsible Party: Quidel Corporation Identifier: NCT01494792     History of Changes
Other Study ID Numbers: CS-0142-02
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012