Strep A FIA Field Study, Sofia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1708 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-07-01

Brief Summary

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To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.

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Detailed Description

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Conditions

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Group A Streptococcus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptomatic population for GAS

This study is a diagnostic study to aid in the detection of Strep throat. No intervention or medication is a part of this study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male and Female, 3 years of age or older
2. Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study.

For example:

1. Acute onset of sore throat
2. Redness of the posterior pharyngeal wall
3. Difficulty/pain on swallowing
4. Fever, \> 37.8º C (100ºF) at presentation or within past 24 hours
5. Pharyngeal exudate
6. Tender cervical lymphadenopathy
7. Absence of cough, runny nose or other upper respiratory symptoms.\*
8. Other, symptoms specific to Strep A not listed above.

* Must include at least one additional symptom from a-f and cannot be the only criteria used to meet inclusion for enrollment in the study.

Exclusion Criteria

1. Subjects currently under treatment with antibiotics are not to be included in this study.
2. At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No