Strep A Fluorescent Immunoassay and Analyzer Field Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01441479

Enrollment

1282

Registered

2011-09-27

Start date

2011-06-30

Completion date

2012-12-31

Last updated

2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strep Throat

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.

Interventions

DEVICEIn Vitro Diagnostic Device aid in diagnosing

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026