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Completed

NCT Number: NCT01441479

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.

Completed

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Key information

Conditions

Strep Throat

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Best Medical Group, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In Vitro Diagnostic Device aid in diagnosing

Device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Quidel Corporation

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 27, 2011
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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